Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

NCT01517412 | Completed Phase 3 Results DMC

• 3 other identifiers: EFC122612011-002416-85U1111-1118-0841
• Study Type: interventional
• Target: 451
• Locations: 10 countries
• Sites: 82

Brief Summary

Primary Objective: \- To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24) Secondary Objective:

• To assess the effect of the 2 lixisenatide regimens on:
• The percentage of participants who reached the target of HbA1c \< 7% or ≤ 6.5% at Week 24
• Fasting Plasma Glucose (FPG)
• 7-point Self-Monitored Plasma Glucose (SMPG) profiles
• Body weight
• To assess the safety and tolerability of the 2 lixisenatide regimens

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c From Baseline to Week 24

  Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last 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 24

Secondary Outcomes (9)

• Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24

  Week 24

• Change in Average 7-point SMPG Profiles From Baseline to Week 24

  Baseline, Week 24

• Change in FPG From Baseline to Week 24

  Baseline, Week 24

• Change in Body Weight From Baseline to Week 24

  Baseline, Week 24

• Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period

  Week 24

Study Arms (2)

Lixisenatide Main Meal

EXPERIMENTAL

Lixisenatide 10 mcg once daily (QD) within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.

Drug: Lixisenatide (AVE0010); Device: Self-injector pen device (OptiClik®); Drug: Metformin

Lixisenatide Breakfast

ACTIVE COMPARATOR

Lixisenatide 10 mcg QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.

Drug: Lixisenatide (AVE0010); Device: Self-injector pen device (OptiClik®); Drug: Metformin

Interventions

Lixisenatide (AVE0010) DRUG

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous

Lixisenatide Breakfast; Lixisenatide Main Meal

Self-injector pen device (OptiClik®) DEVICE

Lixisenatide Breakfast; Lixisenatide Main Meal

Metformin DRUG

To be kept at stable dose (≥1.5 g/day) throughout the study.

Also known as: Route of administration: Oral

Lixisenatide Breakfast; Lixisenatide Main Meal

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 for at least 1 year before screening visit
• Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit.

You may not qualify if:

• Screening HbA1c \< 7.0% and \> 10.0%
• Fasting plasma glucose at screening \> 250 mg/dL (\> 13.9 mmol/L)
• Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening, previous use of insulin
• Participants who usually did not eat breakfast
• Type 1 diabetes mellitus
• Body Mass Index (BMI) ≤ 20 kg/m\^2 and \> 40 kg/m\^2
• Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
• Amylase and/or lipase \> 3 times the upper limit of the normal laboratory range ( ULN) at screening
• Alanine aminotransferase (ALT) \> 3 ULN at screening
• Calcitonin ≧ 20 pg/ml (5.9 pmol/L) at screening
• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
• Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)
• Any contra-indication related to metformin
• Any previous treatment with lixisenatide
• The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (82)

Investigational Site Number 840112

Glendale, Arizona, 85306, United States

Location

Investigational Site Number 840113

Mesa, Arizona, 85213, United States

Location

Investigational Site Number 840105

Phoenix, Arizona, 85028, United States

Location

Investigational Site Number 840102

Tempe, Arizona, 85282, United States

Location

Investigational Site Number 840107

Tempe, Arizona, United States

Location

Investigational Site Number 840116

Mission Viejo, California, 92691, United States

Location

Investigational Site Number 840103

Northridge, California, 91325, United States

Location

Investigational Site Number 840118

Redlands, California, 92374, United States

Location

Investigational Site Number 840104

Temecula, California, 92591, United States

Location

Investigational Site Number 840122

Chicago, Illinois, 60611, United States

Location

Investigational Site Number 840119

Chicago, Illinois, 60616, United States

Location

Investigational Site Number 840114

Springfield, Illinois, 62704, United States

Location

Investigational Site Number 840120

Flint, Michigan, 48504, United States

Location

Investigational Site Number 840115

Billings, Montana, 59103, United States

Location

Investigational Site Number 840101

Sea Girt, New Jersey, 08750, United States

Location

Investigational Site Number 840111

Fargo, North Dakota, 58103, United States

Location

Investigational Site Number 840110

West Jordan, Utah, 84088, United States

Location

Investigational Site Number 124102

Brampton, L6R 3J5, Canada

Location

Investigational Site Number 124108

Coquitlam, V3K 3P4, Canada

Location

Investigational Site Number 124106

Etobicoke, M9R 4E1, Canada

Location

Investigational Site Number 124113

Kelowna, V1Y 1Z9, Canada

Location

Investigational Site Number 124110

Laval, H7T 2P5, Canada

Location

Investigational Site Number 124103

Newmarket, L3Y 5G8, Canada

Location

Investigational Site Number 124101

Oakville, L6H 3P1, Canada

Location

Investigational Site Number 124111

Saint Romuald, G6W 5M6, Canada

Location

Investigational Site Number 124104

Thornhill, L4J 8L7, Canada

Location

Investigational Site Number 124105

Toronto, M9V 4B4, Canada

Location

Investigational Site Number 124112

Vancouver, V5Z 1M9, Canada

Location

Investigational Site Number 203104

Pilsen, 32600, Czechia

Location

Investigational Site Number 203102

Prague, 10000, Czechia

Location

Investigational Site Number 203101

Prague, 10034, Czechia

Location

Investigational Site Number 203105

Prague, 12808, Czechia

Location

Investigational Site Number 203103

Trutnov, 54101, Czechia

Location

Investigational Site Number 203106

Újezd u Brna, 664 53, Czechia

Location

Investigational Site Number 250108

Clermont-Ferrand, 63000, France

Location

Investigational Site Number 250102

Menton, 06500, France

Location

Investigational Site Number 250103

Nanterre, 92014, France

Location

Investigational Site Number 250105

Rennes, 35700, France

Location

Investigational Site Number 276103

Aßlar, 35614, Germany

Location

Investigational Site Number 276102

Bad Mergentheim, 97980, Germany

Location

Investigational Site Number 276107

Berlin, 13125, Germany

Location

Investigational Site Number 276101

Heidelberg, 69115, Germany

Location

Investigational Site Number 276104

Künzing, 94550, Germany

Location

Investigational Site Number 276105

Pirna, 01796, Germany

Location

Investigational Site Number 276108

Saint Ingbert-Oberwürzbach, 66386, Germany

Location

Investigational Site Number 616106

Bytom, 41-902, Poland

Location

Investigational Site Number 616102

Gdansk, 80-858, Poland

Location

Investigational Site Number 616101

Krakow, 31-450, Poland

Location

Investigational Site Number 616103

Lublin, 20-538, Poland

Location

Investigational Site Number 616108

Oświęcim, 32-600, Poland

Location

Investigational Site Number 616105

Wroclaw, 50-127, Poland

Location

Investigational Site Number 616104

Wroclaw, 50-306, Poland

Location

Investigational Site Number 616107

Wroclaw, 50-403, Poland

Location

Investigational Site Number 642101

Bucharest, 050538, Romania

Location

Investigational Site Number 642105

Oradea, 410169, Romania

Location

Investigational Site Number 642102

Ploieşti, 100097, Romania

Location

Investigational Site Number 642104

Reşiţa, 320076, Romania

Location

Investigational Site Number 642103

Timișoara, 300456, Romania

Location

Investigational Site Number 643103

Moscow, 119435, Russia

Location

Investigational Site Number 643101

Moscow, 125367, Russia

Location

Investigational Site Number 643106

Nizhny Novgorod, 603018, Russia

Location

Investigational Site Number 643107

Saint Petersburg, 194291, Russia

Location

Investigational Site Number 643105

Saint Petersburg, 194354, Russia

Location

Investigational Site Number 643110

Saint Petersburg, 195257, Russia

Location

Investigational Site Number 643102

Samara, 443067, Russia

Location

Investigational Site Number 643108

Vladimir, 600023, Russia

Location

Investigational Site Number 643104

Voronezh, 394018, Russia

Location

Investigational Site Number 724107

A Coruña, 15006, Spain

Location

Investigational Site Number 724104

Barcelona, 08020, Spain

Location

Investigational Site Number 724103

Barcelona, 08041, Spain

Location

Investigational Site Number 724102

Ferrol, 15403, Spain

Location

Investigational Site Number 724101

Hostalets de Balenyà, 08550, Spain

Location

Investigational Site Number 724106

Málaga, 29010, Spain

Location

Investigational Site Number 724108

Segovia, 40002, Spain

Location

Investigational Site Number 724105

Seville, 41014, Spain

Location

Investigational Site Number 804108

Kharkiv, 61002, Ukraine

Location

Investigational Site Number 804105

Kharkiv, 61022, Ukraine

Location

Investigational Site Number 804102

Kiev, 2091, Ukraine

Location

Investigational Site Number 804103

Kyiv, 04114, Ukraine

Location

Investigational Site Number 804104

Mykolaiv, 54003, Ukraine

Location

Investigational Site Number 804106

Poltava, 36011, Ukraine

Location

Investigational Site Number 804101

Zaporozhie, 69600, Ukraine

Location

Related Publications (1)

• Ahren B, Vorokhobina N, Souhami E, Demil N, Ye J, Aronson R. Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day. J Diabetes Complications. 2014 Sep-Oct;28(5):735-41. doi: 10.1016/j.jdiacomp.2014.05.012. Epub 2014 Jun 5.

  PMID: 25012990 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lixisenatide; Metformin; Drug Administration Routes

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Drug Therapy; Therapeutics

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 16, 2012
• First Posted: January 25, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 14, 2016
• Results First Posted: October 14, 2016

Record last verified: 2016-08

Locations

US (17); CZ (6); RU (9); FR (4); CA (11); ES (8); UA (7); PL (8); RO (5); DE (7)