Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

NCT01768559 | Completed Phase 3 Results

• 3 other identifiers: EFC126262012-004096-38U1111-1131-4936
• Study Type: interventional
• Target: 894
• Locations: 17 countries
• Sites: 195

Brief Summary

Primary Objective: \- To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin. Secondary Objectives: \- To compare the treatments/regimens on:

• The percentage of participants reaching the target of HbA1c \<7% or ≤6.5%,
• Body weight,
• Self-Monitored Glucose profiles,
• Fasting Plasma Glucose (FPG),
• Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants),
• Daily doses of insulins,
• Safety and tolerability.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Change in HbA1c From Baseline to Week 26

  Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.

  Baseline, Week 26

• Change in Body Weight From Baseline to Week 26

  Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID. Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.

  Baseline, Week 26

Secondary Outcomes (13)

• Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26

  Week 26

• Percentage of Participants With no Weight Gain at Week 26

  Week 26

• Change in Average 7-point SMPG Profiles From Baseline to Week 26

  Baseline, Week 26

• Change in FPG From Baseline to Week 26

  Baseline, Week 26

• Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)

  Baseline, Week 26

Study Arms (3)

Lixisenatide

EXPERIMENTAL

Lixisenatide 10 mcg once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.

Drug: Lixisenatide (AVE0010); Drug: Insulin Glargine (Mandatory background drug); Drug: Metformin (Background drug)

Insulin Glulisine QD

ACTIVE COMPARATOR

Insulin glulisine QD from randomization up to Week 26 on top of Insulin glargine with or without metformin.

Drug: Insulin glulisine QD; Drug: Insulin Glargine (Mandatory background drug); Drug: Metformin (Background drug)

Insulin Glulisine TID

ACTIVE COMPARATOR

Insulin glulisine thrice daily (TID) from randomization up to Week 26 on top of Insulin glargine with or without metformin.

Drug: Insulin glulisine TID; Drug: Insulin Glargine (Mandatory background drug); Drug: Metformin (Background drug)

Interventions

Lixisenatide (AVE0010) DRUG

Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection 30 to 60 minutes before breakfast or dinner.

Also known as: Lyxumia®, Device: Disposable self-injector prefilled pen (Delta 14®)

Lixisenatide

Insulin glulisine QD DRUG

Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before breakfast or dinner. The initial dose was 3-5 units and then individually titrated to obtain the SMPG value \>5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before lunch (if administered at breakfast) or at bedtime (if administered at dinner).

Also known as: HMR1964, Device: Disposable self-injector prefilled pen (Apidra® Solostar®)

Insulin Glulisine QD

Insulin glulisine TID DRUG

Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before each meal. The initial dose was 3-5 units for each meal and then individually titrated to obtain the SMPG value \>5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before the next meal or at bedtime (for injection at dinner).

Also known as: HMR1964, Device: Disposable self-injector prefilled pen (Apidra® Solostar®)

Insulin Glulisine TID

Insulin Glargine (Mandatory background drug) DRUG

Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection at breakfast or dinner. Doses were adjusted to maintain a fasting self-monitored plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL).

Also known as: Device: Disposable self-injector prefilled pen (Lantus® Solostar®)

Insulin Glulisine QD; Insulin Glulisine TID; Lixisenatide

Metformin (Background drug) DRUG

Pharmaceutical form: Tablet; Route of administration: Oral administration. If previously taken, Metformin to be continued at stable dose (≥1.5 g/day) throughout the study.

Insulin Glulisine QD; Insulin Glulisine TID; Lixisenatide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with type 2 diabetes mellitus diagnosed at least 1 year before screening visit (V1).
• Participants treated with basal insulin for at least 6 months.
• Participants treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20%) and ≥20 U/day for at least 2 months prior to visit 1.
• Participants treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that could be: metformin (≥1.5 g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide. The dose of OADs should be stable for at least 3 months prior to visit 1.

You may not qualify if:

• At screening: age \< legal age of majority.
• At screening, HbA1c: \<7.5% and \>10.0% for participants treated with basal insulin alone or in combination with metformin only; \< 7.0% and \> 10.0% for participants treated with basal insulin and a combination of oral anti-diabetic drugs which included a SU and/or a DPP-4 inhibitor and/or a glinide.
• Women of childbearing potential with no effective contraceptive method, pregnancy or lactation.
• Type 1 diabetes mellitus.
• Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness.
• Any previous treatment with lixisenatide, or any discontinuation from another glucagon-like peptide 1 (GLP-1) receptor agonist due to safety/tolerability issue or lack of efficacy.
• At screening, Body Mass Index (BMI) ≤20 or \>40 kg/m\^2.
• Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening.
• Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures.
• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.
• At screening resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>95 mmHg.
• Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposed to MTC (e.g. multiple endocrine neoplasia syndromes).
• Contraindication related to metformin (for participant receiving this treatment), insulin glargine, insulin glulisine or lixisenatide.
• Participants with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.
• At screening, amylase and/or lipase \>3 times the upper limit of the normal laboratory range (ULN).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (199)

Investigational Site Number 840043

Sun City, Arizona, 85351, United States

Location

Investigational Site Number 840042

Tempe, Arizona, 85282, United States

Location

Investigational Site Number 840003

Little Rock, Arkansas, 72205, United States

Location

Investigational Site Number 840031

La Mesa, California, 91942, United States

Location

Investigational Site Number 840005

Mission Viejo, California, 92691, United States

Location

Investigational Site Number 840057

Northridge, California, 91325, United States

Location

Investigational Site Number 840035

Santa Ana, California, 92704, United States

Location

Investigational Site Number 840002

Temecula, California, 92591, United States

Location

Investigational Site Number 840037

Walnut Creek, California, 94598, United States

Location

Investigational Site Number 840023

West Hills, California, 91345, United States

Location

Investigational Site Number 840041

Denver, Colorado, 80246, United States

Location

Investigational Site Number 840012

Miami, Florida, 33136, United States

Location

Investigational Site Number 840061

Miami, Florida, 33142, United States

Location

Investigational Site Number 840045

Lawrenceville, Georgia, 30045, United States

Location

Investigational Site Number 840036

Nampa, Idaho, 83686, United States

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Investigational Site Number 840024

Chicago, Illinois, 60611, United States

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Investigational Site Number 840009

Evanston, Illinois, 60201, United States

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Investigational Site Number 840004

Avon, Indiana, 46123, United States

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Investigational Site Number 840055

Avon, Indiana, 46123, United States

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Investigational Site Number 840027

Des Moines, Iowa, 50314, United States

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Investigational Site Number 840006

Wichita, Kansas, 67203, United States

Location

Investigational Site Number 840047

Lexington, Kentucky, 40504, United States

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Investigational Site Number 840056

Paducah, Kentucky, 42003, United States

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Investigational Site Number 840022

Marrero, Louisiana, 70072, United States

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Investigational Site Number 840016

Baltimore, Maryland, 21237, United States

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Investigational Site Number 840017

Rockville, Maryland, 20852, United States

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Investigational Site Number 840025

Buckley, Michigan, 49620, United States

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Investigational Site Number 840048

Dearborn, Michigan, 48124, United States

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Investigational Site Number 840026

Kalamazoo, Michigan, 49048, United States

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Investigational Site Number 840049

Las Vegas, Nevada, 89148, United States

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Investigational Site Number 840029

New Hyde Park, New York, 11042, United States

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Investigational Site Number 840060

Smithtown, New York, 11787, United States

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Investigational Site Number 840030

Staten Island, New York, 10301-3914, United States

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Investigational Site Number 840011

Salisbury, North Carolina, 28144, United States

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Investigational Site Number 840028

Fargo, North Dakota, 58103, United States

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Investigational Site Number 840007

Oklahoma City, Oklahoma, 73104, United States

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Investigational Site Number 840021

Pittsburgh, Pennsylvania, 15212, United States

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Investigational Site Number 840052

Myrtle Beach, South Carolina, 29572, United States

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Investigational Site Number 840032

Chattanooga, Tennessee, 37404, United States

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Investigational Site Number 840033

Nashville, Tennessee, 37232, United States

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Investigational Site Number 840034

Corpus Christi, Texas, 78404, United States

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Investigational Site Number 840001

Dallas, Texas, 75230, United States

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Investigational Site Number 840020

Houston, Texas, 77081, United States

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Investigational Site Number 840018

Norfolk, Virginia, 23502, United States

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Investigational Site Number 840015

Salem, Virginia, 24153, United States

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Investigational Site Number 840010

Milwaukee, Wisconsin, 53217, United States

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Investigational Site Number 124008

Brampton, L6R 3J5, Canada

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Investigational Site Number 124015

Burlington, L7M 4Y1, Canada

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Investigational Site Number 124018

Chatham, N7L 1C1, Canada

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Investigational Site Number 124004

Coquitlam, V3K 3P4, Canada

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Investigational Site Number 124016

Etobicoke, M9R 4E1, Canada

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Investigational Site Number 124014

Hamilton, L8L 5G8, Canada

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Investigational Site Number 124020

Montreal, H1Y 3L1, Canada

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Investigational Site Number 124011

Montreal, H3A 1A1, Canada

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Investigational Site Number 124017

Newmarket, L3Y 5G8, Canada

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Investigational Site Number 124021

Québec, G1N 4V3, Canada

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Investigational Site Number 124003

Red Deer, T4N 6V7, Canada

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Investigational Site Number 124012

Saint Romuald, G6W 5M6, Canada

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Investigational Site Number 124002

Sherbrooke, J1H 5N4, Canada

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Investigational Site Number 124001

Toronto, M4G 3E8, Canada

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Investigational Site Number 124010

Toronto, M5C 2T2, Canada

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Investigational Site Number 124005

Vancouver, V5Z 1M9, Canada

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Investigational Site Number 124006

Victoria, V8V 4A1, Canada

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Investigational Site Number 124007

Winnipeg, R3E 3P4, Canada

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Investigational Site Number 152103

Santiago, 7500010, Chile

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Investigational Site Number 152107

Santiago, 7500347, Chile

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Investigational Site Number 152101

Santiago, 7500710, Chile

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Investigational Site Number 152105

Santiago, 7591047, Chile

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Investigational Site Number 152102

Santiago, 7980378, Chile

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Investigational Site Number 152106

Santiago, 8053095, Chile

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Investigational Site Number 152108

Santiago, 8053095, Chile

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Investigational Site Number 152109

Santiago, Chile

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Investigational Site Number 203107

Beroun, 26601, Czechia

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Investigational Site Number 203103

Jílové u Prahy, 254 01, Czechia

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Investigational Site Number 203101

Ostrava, 702 00, Czechia

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Investigational Site Number 203110

Police nad Metují, 549 54, Czechia

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Investigational Site Number 203105

Prague, 14021, Czechia

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Investigational Site Number 203102

Prague, 148 00, Czechia

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Investigational Site Number 203108

Prague, 14900, Czechia

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Investigational Site Number 203104

Trutnov, 54101, Czechia

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Investigational Site Number 233102

Pärnu, 80018, Estonia

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Investigational Site Number 233103

Tallinn, 13415, Estonia

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Investigational Site Number 233104

Tallinn, 13419, Estonia

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Investigational Site Number 233101

Viljandimaa, 71024, Estonia

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Investigational Site Number 250108

Bois-Guillaume, 76230, France

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Investigational Site Number 250105

Corbeil-Essonnes, 91100, France

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Investigational Site Number 250104

La Rochelle, 17019, France

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Investigational Site Number 250106

Lyon, 69495, France

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Investigational Site Number 250107

Lyon, 69495, France

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Investigational Site Number 250109

Mantes-la-Jolie, 78200, France

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Investigational Site Number 250102

Paris, 75908, France

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Investigational Site Number 250101

Vandœuvre-lès-Nancy, 54511, France

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Investigational Site Number 250103

Vénissieux, 69200, France

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Investigational Site Number 276112

Bad Mergentheim, 97980, Germany

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Investigational Site Number 276108

Berlin, 13125, Germany

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Investigational Site Number 276102

Dortmund, 44137, Germany

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Investigational Site Number 276120

Dresden, 01067, Germany

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Investigational Site Number 276106

Dresden, 01307, Germany

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Investigational Site Number 276117

Frankfurt A.M., 60596, Germany

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Investigational Site Number 276116

Görlitz, 02826, Germany

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Investigational Site Number 276113

Heidelberg, 69115, Germany

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Investigational Site Number 276118

Leipzig, 04103, Germany

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Investigational Site Number 276119

Magdeburg, 39104, Germany

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Investigational Site Number 276103

Neumünster, 24534, Germany

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Investigational Site Number 276109

Saint Ingbert-Oberwürzbach, 66386, Germany

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Investigational Site Number 276115

Speyer, 67346, Germany

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Investigational Site Number 348107

Budapest, 1134, Hungary

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Investigational Site Number 348108

Budapest, 1138, Hungary

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Investigational Site Number 348102

Budapest, 1139, Hungary

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Investigational Site Number 348101

Eger, 3300, Hungary

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Investigational Site Number 348103

Pápa, 8500, Hungary

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Investigational Site Number 348106

Sátoraljaújhely, 3980, Hungary

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Investigational Site Number 348104

Szeged, 6720, Hungary

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Investigational Site Number 348105

Zalaegerszeg, 8900, Hungary

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Investigational Site Number 380103

Bologna, 40138, Italy

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Investigational Site Number 380102

Catania, 95122, Italy

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Investigational Site Number 380101

Milan, 20132, Italy

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Investigational Site Number 380105

Napoli, 80131, Italy

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Investigational Site Number 380104

Torino, 10126, Italy

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Investigational Site Number 428103

Jelgava, LV-3001, Latvia

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Investigational Site Number 428104

Ogre, LV-5001, Latvia

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Investigational Site Number 428102

Riga, LV-1002, Latvia

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Investigational Site Number 428105

Riga, LV-1006, Latvia

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Investigational Site Number 428101

Sigulda, LV-2150, Latvia

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Investigational Site Number 440104

Jonava, LT-55201, Lithuania

Location

Investigational Site Number 440103

Kaunas, LT-48259, Lithuania

Location

Investigational Site Number 440102

Kaunas, LT-49456, Lithuania

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Investigational Site Number 440101

Kaunas, LT-51270, Lithuania

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Investigational Site Number 440105

Klaipėda, LT-92288, Lithuania

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Investigational Site Number 484108

Chihuahua City, 31200, Mexico

Location

Investigational Site Number 484101

Cuernavaca, 62250, Mexico

Location

Investigational Site Number 484111

Durango, 34080, Mexico

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Investigational Site Number 484104

Guadalajara, 44150, Mexico

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Investigational Site Number 484109

Guadalajara, 44210, Mexico

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Investigational Site Number 484107

Guadalajara, 44600, Mexico

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Investigational Site Number 484105

Guadalajara, 44650, Mexico

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Investigational Site Number 484110

Guadalajara, 44656, Mexico

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Investigational Site Number 484103

Mexico City, 11850, Mexico

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Investigational Site Number 484102

México, 06700, Mexico

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Investigational Site Number 484106

Monterrey, 64000, Mexico

Location

Investigational Site Number 616101

Bialystok, 15-435, Poland

Location

Investigational Site Number 616103

Bydgoszcz, 85-822, Poland

Location

Investigational Site Number 616102

Bytom, 41-902, Poland

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Investigational Site Number 616106

Krakow, 31-455, Poland

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Investigational Site Number 616104

Krakow, 31-548, Poland

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Investigational Site Number 616105

Puławy, 24-100, Poland

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Investigational Site Number 616107

Warsaw, 02-507, Poland

Location

Investigational Site Number 642105

Bacau, 600114, Romania

Location

Investigational Site Number 642108

Cluj-Napoca, 400006, Romania

Location

Investigational Site Number 642106

Deva, 330084, Romania

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Investigational Site Number 642113

Galati, 800098, Romania

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Investigational Site Number 642107

Hunedoara, 331057, Romania

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Investigational Site Number 642117

Iași, 700547, Romania

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Investigational Site Number 642103

Oradea, 410169, Romania

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Investigational Site Number 642104

Oradea, 410169, Romania

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Investigational Site Number 642112

Piteşti, 110084, Romania

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Investigational Site Number 642114

Ploieşti, 100342, Romania

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Investigational Site Number 642102

Reşiţa, 320076, Romania

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Investigational Site Number 642111

Sibiu, 550371, Romania

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Investigational Site Number 642109

Târgu Mureş, 540142, Romania

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Investigational Site Number 642110

Târgu Mureş, 540142, Romania

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Investigational Site Number 642116

Timișoara, 300133, Romania

Location

Investigational Site Number 642101

Timișoara, 300456, Romania

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Investigational Site Number 642115

Timișoara, 300723, Romania

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Investigational Site Number 643111

Moscow, 117036, Russia

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Investigational Site Number 643107

Moscow, 119991, Russia

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Investigational Site Number 643105

Moscow, 129110, Russia

Location

Investigational Site Number 643110

Penza, 440026, Russia

Location

Investigational Site Number 643101

Saint Petersburg, 194044, Russia

Location

Investigational Site Number 643104

Saint Petersburg, 194354, Russia

Location

Investigational Site Number 643109

Saint Petersburg, 194354, Russia

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Investigational Site Number 643106

Saint Petersburg, 194358, Russia

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Investigational Site Number 643108

Saint Petersburg, 195112, Russia

Location

Investigational Site Number 643103

Saint Petersburg, 195257, Russia

Location

Investigational Site Number 643102

Saratov, 410030, Russia

Location

Investigational Site Number 724105

A Coruña, 15006, Spain

Location

Investigational Site Number 724102

Ferrol, 15403, Spain

Location

Investigational Site Number 724103

Málaga, 29010, Spain

Location

Investigational Site Number 724104

Seville, 41010, Spain

Location

Investigational Site Number 804104

Chernivtsi, 58022, Ukraine

Location

Investigational Site Number 804107

Donetsk, 83003, Ukraine

Location

Investigational Site Number 804103

Donetsk, 83059, Ukraine

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Investigational Site Number 804108

Mykolaiv, 54003, Ukraine

Location

Investigational Site Number 804110

Odesa, 65059, Ukraine

Location

Investigational Site Number 804105

Vinnytsia, 21001, Ukraine

Location

Investigational Site Number 804102

Vinnytsia, 21010, Ukraine

Location

Investigational Site Number 804111

Zaporizhia, 69600, Ukraine

Location

Investigational Site Number 826006

Ashton-under-Lyne, OL6 9RW, United Kingdom

Location

Investigational Site Number 826002

Birmingham, B9 5SS, United Kingdom

Location

Investigational Site Number 826007

Carmarthen, SA31 2AF, United Kingdom

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Investigational Site Number 826005

Chester, CH2 1UL, United Kingdom

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Investigational Site Number 826008

Coventry, CV1 4FH, United Kingdom

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Investigational Site Number 826009

Dundee, DD1 9SI, United Kingdom

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Investigational Site Number 826001

Durham, DH1 5TW, United Kingdom

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Investigational Site Number 826011

Haddington, EH41 3PF, United Kingdom

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Investigational Site Number 826012

Leicester, LE5 4PW, United Kingdom

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Investigational Site Number 826010

Plymouth, PL6 8BX, United Kingdom

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Investigational Site Number 826004

Sheffield, S5 7AU, United Kingdom

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Investigational Site Number 826003

St Helens, WA93DA, United Kingdom

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Related Publications (3)

• Rosenstock J, Guerci B, Hanefeld M, Gentile S, Aronson R, Tinahones FJ, Roy-Duval C, Souhami E, Wardecki M, Ye J, Perfetti R, Heller S; GetGoal Duo-2 Trial Investigators. Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial. Diabetes Care. 2016 Aug;39(8):1318-28. doi: 10.2337/dc16-0014. Epub 2016 May 23.

  PMID: 27222510 RESULT

• Tabak AG, Anderson J, Aschner P, Liu M, Saremi A, Stella P, Tinahones FJ, Wysham C, Meier JJ. Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis. Diabetes Ther. 2020 Jan;11(1):305-318. doi: 10.1007/s13300-019-00735-7. Epub 2019 Dec 17.

  PMID: 31848983 DERIVED

• Rosenstock J, Handelsman Y, Vidal J, Ampudia Blasco FJ, Giorgino F, Liu M, Perfetti R, Meier JJ. Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes. Diabetes Obes Metab. 2018 Dec;20(12):2821-2829. doi: 10.1111/dom.13462. Epub 2018 Aug 13.

  PMID: 29974618 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lixisenatide; Insulin Glargine; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 15, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 4, 2017
• Results First Posted: January 4, 2017

Record last verified: 2016-11

Locations

CZ (8); CL (8); RO (17); IT (5); PL (7); LA (5); DE (13); FR (9); LI (5); HU (8); CA (18); RU (11); GB (12); UA (8); ME (11); US (46); ES (4)