Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications

NCT02320721 | Completed Phase 3 Results

• 3 other identifiers: EFC137992014-002399-10U1111-1159-3018
• Study Type: interventional
• Target: 1,014
• Locations: 18 countries
• Sites: 162

Brief Summary

Primary Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c). Secondary Objectives: To demonstrate the superiority of H0E901-U300 in comparison with Lantus in:

• Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event from 22:00 to 08:59 next morning
• Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dL \[3.9mmol/L\]) hypoglycemia event
• Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL \[3.9mmol/L\]) hypoglycemia event occurring at any time of day
• HbA1c change

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c From Baseline to Week 26

  Adjusted least square (LS) means were obtained from analysis of covariance (ANCOVA) after multiple imputation of missing data including post baseline HbA1c data during the 26-week randomized period.

  Baseline, Week 26

Secondary Outcomes (8)

• Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (22:00 to 08:59 Hours Next Morning) During 26-Week Randomized Period

  Baseline up to Week 26

• Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (00:00 to 05:59 Hours) During 26-Week Randomized Period

  Baseline up to Week 26

• Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia Occurring at Any Time of the Day During 26-Week Randomized Period

  Baseline up to Week 26

• Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period

  Baseline up to Week 26

• Percentage of Participants With HbA1c <7.5% or <7.0% at Week 26 and No Severe and/or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia During 26-Week Randomized Period

  Baseline up to Week 26

Other Outcomes (2)

• Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment

  Baseline up to Week 26

• Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year During the 26 Weeks of Treatment

  Baseline up to Week 26

Study Arms (2)

HOE901-U300

EXPERIMENTAL

HOE901-U300 (Insulin glargine, 300 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.

Drug: Insulin Glargine (HOE901 - U300); Drug: Background therapy

Lantus

ACTIVE COMPARATOR

Lantus (Insulin glargine, 100 U/mL) once daily up to Week 26 on top of stable non-insulin antihyperglycemic therapy.

Drug: Insulin Glargine (HOE901 - U100); Drug: Background therapy

Interventions

Insulin Glargine (HOE901 - U300) DRUG

Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).

Also known as: Toujeo®

HOE901-U300

Insulin Glargine (HOE901 - U100) DRUG

Self-administered by SC injection in the evening using a pre-filled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).

Also known as: Lantus®

Lantus

Background therapy DRUG

Non-insulin anti-diabetic drugs with the exception of thiazolidinediones.

HOE901-U300; Lantus

Eligibility Criteria

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

You may qualify if:

• Participants ≥65 years old with type 2 diabetes mellitus, inadequately controlled on antidiabetic regimens either including no insulin, or with basal insulin as their only insulin.
• Signed informed consent.

You may not qualify if:

• HbA1c at screening visit:
• \<7.0% or \>10.0% for participants taking basal insulin.
• \<7.5% or \>11.0% for insulin-naïve participants.
• History of type 2 diabetes mellitus for less than 1 year before screening.
• Participants not on stable basal insulin dose (±10% in the last 8 weeks prior to screening visit).
• Change in dose of antidiabetic treatment or initiation of new glucose-lowering medications in the last 8 weeks prior to screening.
• Chronic (\>10 days continuous use in previous 6 months) use of bolus insulin injections, whether given separately or as part of a combination with basal insulin, e.g. premix insulin; For insulin-naïve individuals: current or previous insulin use except for a maximum of 10 consecutive days (e.g. acute illness, surgery) during the last year prior to screening.
• Cognitive disorder and dementia assessed clinically and by Mini-Mental State Examination (MMSE) score \<24, or any neurologic disorder that would likely affect the participant's ability to follow the study procedure. The participant would be eligible despite an MMSE score \<24 if the investigator determined that the low score reflected educational or cultural background and not dementia as long as the participant was otherwise able to meet the study requirements.
• Participants who had end-stage renal disease (\<15 mL/min/1.73m\^2, per estimated Glomerular filtration rate (eGFR) measurement by Modification of Diet in Renal Disease (MDRD).
• 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 (162)

Investigational Site Number 840058

Saraland, Alabama, 36571, United States

Location

Investigational Site Number 840019

Fresno, California, 93720, United States

Location

Investigational Site Number 840021

Fresno, California, 93722, United States

Location

Investigational Site Number 840040

Greenbrae, California, 94904, United States

Location

Investigational Site Number 840070

Huntington Park, California, 90255, United States

Location

Investigational Site Number 840064

Los Angeles, California, 90057, United States

Location

Investigational Site Number 840031

Norwalk, California, 90650, United States

Location

Investigational Site Number 840065

Oakland, California, 94612, United States

Location

Investigational Site Number 840050

Orange, California, 92868, United States

Location

Investigational Site Number 840036

Simi Valley, California, 93065, United States

Location

Investigational Site Number 840003

Temecula, California, 92591, United States

Location

Investigational Site Number 840062

Walnut Creek, California, 94598, United States

Location

Investigational Site Number 840027

Longmont, Colorado, 80501, United States

Location

Investigational Site Number 840030

Bradenton, Florida, 34208, United States

Location

Investigational Site Number 840010

Miami, Florida, 33156, United States

Location

Investigational Site Number 840035

Miami, Florida, 33156, United States

Location

Investigational Site Number 840014

New Port Richey, Florida, 34652, United States

Location

Investigational Site Number 840051

Ocoee, Florida, 34761, United States

Location

Investigational Site Number 840056

Palm Harbor, Florida, 34684, United States

Location

Investigational Site Number 840007

St. Petersburg, Florida, United States

Location

Investigational Site Number 840041

Roswell, Georgia, 30076, United States

Location

Investigational Site Number 840053

Statesboro, Georgia, 30461, United States

Location

Investigational Site Number 840042

Woodstock, Georgia, 30189, United States

Location

Investigational Site Number 840005

Arlington Heights, Illinois, 60005, United States

Location

Investigational Site Number 840004

Peoria, Illinois, 61602, United States

Location

Investigational Site Number 840029

Springfield, Illinois, 62704, United States

Location

Investigational Site Number 840013

Avon, Indiana, 46123, United States

Location

Investigational Site Number 840023

Avon, Indiana, 46123, United States

Location

Investigational Site Number 840039

Evansville, Indiana, 47714, United States

Location

Investigational Site Number 840006

Muncie, Indiana, 47304, United States

Location

Investigational Site Number 840026

Des Moines, Iowa, 50314, United States

Location

Investigational Site Number 840033

West Des Moines, Iowa, 50266, United States

Location

Investigational Site Number 840032

Overland Park, Kansas, 66209, United States

Location

Investigational Site Number 840069

Metairie, Louisiana, 70006, United States

Location

Investigational Site Number 840020

Flint, Michigan, 48504, United States

Location

Investigational Site Number 840037

Nashua, New Hampshire, 03063, United States

Location

Investigational Site Number 840018

New York, New York, 10001, United States

Location

Investigational Site Number 840048

Asheville, North Carolina, 28805, United States

Location

Investigational Site Number 840009

Charlotte, North Carolina, 28209, United States

Location

Investigational Site Number 840011

Greensboro, North Carolina, 27408, United States

Location

Investigational Site Number 840047

Greenville, North Carolina, 27834, United States

Location

Investigational Site Number 840016

Salisbury, North Carolina, 28144, United States

Location

Investigational Site Number 840012

Wilmington, North Carolina, 28401, United States

Location

Investigational Site Number 840022

Fargo, North Dakota, 58103, United States

Location

Investigational Site Number 840072

Cincinnati, Ohio, 45219, United States

Location

Investigational Site Number 840054

Wadsworth, Ohio, 44281, United States

Location

Investigational Site Number 840067

Bend, Oregon, 97702, United States

Location

Investigational Site Number 840057

Corvallis, Oregon, 97330, United States

Location

Investigational Site Number 840045

Feasterville, Pennsylvania, 19053, United States

Location

Investigational Site Number 840017

Pittsburgh, Pennsylvania, 15220, United States

Location

Investigational Site Number 840059

Greenville, South Carolina, 29605, United States

Location

Investigational Site Number 840015

Greer, South Carolina, 29651, United States

Location

Investigational Site Number 840002

Chattanooga, Tennessee, 37404, United States

Location

Investigational Site Number 840046

Chattanooga, Tennessee, 37404, United States

Location

Investigational Site Number 840034

Knoxville, Tennessee, 37912, United States

Location

Investigational Site Number 840055

Arlington, Texas, 76014, United States

Location

Investigational Site Number 840001

Dallas, Texas, 75230, United States

Location

Investigational Site Number 840024

Irving, Texas, 75039, United States

Location

Investigational Site Number 840061

North Richland Hills, Texas, 76180, United States

Location

Investigational Site Number 840028

Richmond, Texas, 77469, United States

Location

Investigational Site Number 840063

San Antonio, Texas, 78230, United States

Location

Investigational Site Number 840038

St. George, Utah, 84790, United States

Location

Investigational Site Number 840025

Federal Way, Washington, 98003, United States

Location

Investigational Site Number 840060

Bridgeport, West Virginia, 26330, United States

Location

Investigational Site Number 032001

Caba, 1120, Argentina

Location

Investigational Site Number 032002

Caba, 1405, Argentina

Location

Investigational Site Number 032006

Capital Federal, 1180, Argentina

Location

Investigational Site Number 032004

Ciudad Autonoma de Buenos Aire, 1206, Argentina

Location

Investigational Site Number 032003

Mar del Plata, 7602, Argentina

Location

Investigational Site Number 036002

Box Hill, 3128, Australia

Location

Investigational Site Number 036004

Fitzroy, 3065, Australia

Location

Investigational Site Number 036001

Geelong, 3220, Australia

Location

Investigational Site Number 036003

Herston, 4029, Australia

Location

Investigational Site Number 124003

Brampton, L6S 0C9, Canada

Location

Investigational Site Number 124005

Burlington, L7M 4Y1, Canada

Location

Investigational Site Number 124008

Chatham, N7L 1C1, Canada

Location

Investigational Site Number 124010

Mirabel, J7J 2K8, Canada

Location

Investigational Site Number 124009

Montreal, H2X 0A9, Canada

Location

Investigational Site Number 124006

Sainte-Foy, G1W4R4, Canada

Location

Investigational Site Number 124004

Thornhill, L4J 8L7, Canada

Location

Investigational Site Number 124002

Toronto, M4G 3E8, Canada

Location

Investigational Site Number 124001

Vancouver, V5Y 3W2, Canada

Location

Investigational Site Number 124007

Vancouver, V5Z 1L8, Canada

Location

Investigational Site Number 170004

Armenia, 630004, Colombia

Location

Investigational Site Number 170007

Barranquilla, 80020, Colombia

Location

Investigational Site Number 170001

Bogotá, 110221, Colombia

Location

Investigational Site Number 170005

Bogotá, 111311, Colombia

Location

Investigational Site Number 170003

Manizales, 170004, Colombia

Location

Investigational Site Number 250004

Lyon, 69495, France

Location

Investigational Site Number 250006

Nantes, 44093, France

Location

Investigational Site Number 250005

Poitiers, 86021, France

Location

Investigational Site Number 276004

Dresden, 01307, Germany

Location

Investigational Site Number 276003

Essen, 45359, Germany

Location

Investigational Site Number 276001

München, 81925, Germany

Location

Investigational Site Number 276005

Potsdam, 14469, Germany

Location

Investigational Site Number 276002

Saarlouis, 66740, Germany

Location

Investigational Site Number 348004

Balatonfüred, 8230, Hungary

Location

Investigational Site Number 348001

Budapest, 1036, Hungary

Location

Investigational Site Number 348005

Budapest, 1062, Hungary

Location

Investigational Site Number 348007

Budapest, 1062, Hungary

Location

Investigational Site Number 348003

Budapest, 1213, Hungary

Location

Investigational Site Number 348008

Csongrád, 6640, Hungary

Location

Investigational Site Number 348009

Debrecen, 4031, Hungary

Location

Investigational Site Number 348002

Gyula, 5700, Hungary

Location

Investigational Site Number 380004

Bologna, 40138, Italy

Location

Investigational Site Number 380005

Chieti, 66013, Italy

Location

Investigational Site Number 380003

Genova, 16132, Italy

Location

Investigational Site Number 380002

Milan, 20122, Italy

Location

Investigational Site Number 380001

Milan, 20132, Italy

Location

Investigational Site Number 392008

Adachi-Ku, Japan

Location

Investigational Site Number 392003

Atsugi-Shi, Japan

Location

Investigational Site Number 392002

Kamakura-Shi, Japan

Location

Investigational Site Number 392010

Sagamihara-Shi, Japan

Location

Investigational Site Number 392004

Sakado-Shi, Japan

Location

Investigational Site Number 392013

Sapporo, Japan

Location

Investigational Site Number 392012

Sendai, Japan

Location

Investigational Site Number 484002

Aguascalientes, 20230, Mexico

Location

Investigational Site Number 484004

Cuernavaca, 62250, Mexico

Location

Investigational Site Number 484001

Guadalajara, 44150, Mexico

Location

Investigational Site Number 484003

Monterrey, 64460, Mexico

Location

Investigational Site Number 604004

Arequipa, Peru

Location

Investigational Site Number 604007

Ica, 056, Peru

Location

Investigational Site Number 604002

Lima, 27, Peru

Location

Investigational Site Number 604005

Lima, Lima 09, Peru

Location

Investigational Site Number 604001

Lima, LIMA 14, Peru

Location

Investigational Site Number 604006

Lima, Lima 32, Peru

Location

Investigational Site Number 604003

Piura, 20001, Peru

Location

Investigational Site Number 616005

Lublin, 20-538, Poland

Location

Investigational Site Number 616004

Szczecin, 70-506, Poland

Location

Investigational Site Number 616003

Warsaw, 02-507, Poland

Location

Investigational Site Number 616002

Warsaw, 03-242, Poland

Location

Investigational Site Number 616001

Zabrze, 41-800, Poland

Location

Investigational Site Number 642006

Bacau, 600154, Romania

Location

Investigational Site Number 642001

Bucharest, 020042, Romania

Location

Investigational Site Number 642007

Constanța, 900675, Romania

Location

Investigational Site Number 642004

Oradea, 410159, Romania

Location

Investigational Site Number 642005

Sibiu, 550371, Romania

Location

Investigational Site Number 642002

Târgu Mureş, 540142, Romania

Location

Investigational Site Number 642003

Târgu Mureş, 540142, Romania

Location

Investigational Site Number 410003

Seoul, 110-744, South Korea

Location

Investigational Site Number 410005

Seoul, 110-746, South Korea

Location

Investigational Site Number 410002

Seoul, 135-710, South Korea

Location

Investigational Site Number 410001

Seoul, 136-705, South Korea

Location

Investigational Site Number 410004

Wŏnju, 220-701, South Korea

Location

Investigational Site Number 724008

A Coruña, 15006, Spain

Location

Investigational Site Number 724004

Alzira, 46600, Spain

Location

Investigational Site Number 724001

Badalona, 08916, Spain

Location

Investigational Site Number 724002

Ferrol, 15405, Spain

Location

Investigational Site Number 724006

Málaga, 29010, Spain

Location

Investigational Site Number 724007

Quart de Poblet, 46930, Spain

Location

Investigational Site Number 724003

Sanlúcar de Barrameda, 11540, Spain

Location

Investigational Site Number 724005

Seville, 41071, Spain

Location

Investigational Site Number 752002

Gothenburg, 405 45, Sweden

Location

Investigational Site Number 752004

Härnösand, 871 82, Sweden

Location

Investigational Site Number 752003

Rättvik, 79530, Sweden

Location

Investigational Site Number 752001

Västra Frölunda, 421 44, Sweden

Location

Investigational Site Number 826003

Belfast, BT12 6BA, United Kingdom

Location

Investigational Site Number 826005

Belfast, BT16 1RH, United Kingdom

Location

Investigational Site Number 826001

Bristol, BS10 5NB, United Kingdom

Location

Investigational Site Number 826004

Redhill, RH1 5RH, United Kingdom

Location

Investigational Site Number 826006

Rotherham, S60 2UD, United Kingdom

Location

Investigational Site Number 826002

Swansea, SA2 8PP, United Kingdom

Location

Related Publications (1)

• Ritzel R, Harris SB, Baron H, Florez H, Roussel R, Espinasse M, Muehlen-Bartmer I, Zhang N, Bertolini M, Brulle-Wohlhueter C, Munshi M, Bolli GB. A Randomized Controlled Trial Comparing Efficacy and Safety of Insulin Glargine 300 Units/mL Versus 100 Units/mL in Older People With Type 2 Diabetes: Results From the SENIOR Study. Diabetes Care. 2018 Aug;41(8):1672-1680. doi: 10.2337/dc18-0168. Epub 2018 Jun 12.

  PMID: 29895556 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

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

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: December 16, 2014
• First Posted: December 19, 2014
• Study Start: January 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 21, 2020
• Results First Posted: July 11, 2017

Record last verified: 2020-04

Locations

JP (7); AU (4); AR (5); ES (8); FR (3); GB (6); PL (5); US (64); SE (4); PE (7); ME (4); RO (7); CO (5); IT (5); KR (5); CA (10); HU (8); DE (5)