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Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01476475
First received: November 4, 2011
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

Primary Objective:

  • The purpose of this study is to compare insulin glargine/ lixisenatide fixed ratio combination versus insulin glargine on glycemic control over 24 weeks, as evaluated by HbA1c (glycosylated hemoglobin) reduction in type 2 diabetic patients treated with metformin

Secondary Objectives:

  • To compare insulin glargine/lixisenatide fixed ratio combination versus insulin glargine over 24 weeks on:

    • Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test
    • Percentage of patients reaching HbA1c <7% or ≤6.5%
    • 7-point Self-Monitored Plasma Glucose (SMPG) profile
    • Body weight
    • Insulin glargine dose
    • Fasting Plasma Glucose (FPG)
    • Percentage of patients requiring rescue therapy during the 24-week open label treatment period
  • To assess safety and tolerability of insulin glargine/ lixisenatide fixed ratio combination.

Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Insulin glargine /lixisenatide fixed combination (HOE901/AVE0010)
Drug: Insulin glargine (HOE901)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, 24-week, Open-label, 2-arm Parallel-group, Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in 2-hour post-prandial glucose during meal test [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in 2-hour blood glucose excursion during meal test [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
    derived as: 2-hour Post-Prandial Glucose - Plasma glucose 30 minutes prior to the meal test, before IMP administration) from baseline to week 24

  • Percentage of patients reaching HbA1c ≤6.5 % or <7 % [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Change in 7-point SMPG profiles [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Insulin glargine dose [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Change in FPG [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Percentage of patients requiring rescue therapy during the 24-week open-label treatment period [ Time Frame: over the 24-week treatment period ] [ Designated as safety issue: No ]

Enrollment: 323
Study Start Date: November 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin glargine /lixisenatide fixed combination

The insulin glargine /lixisenatide fixed ratio combination is self-administered once daily in the morning within one hour before breakfast. Treatment will be initiated and individually adjusted weekly according to fasting self measured plasma glucose (SMPG) (target fasting SMPG between 80 and 100 mg/dl (4.4 and 5.6 mmol/l).

Subjects should continue their pre-trial treatment with metformin.

 Drug: Insulin glargine /lixisenatide fixed combination (HOE901/AVE0010)

Pharmaceutical form:Solution for injection using a re-usable pen-type self-injector device (Tactipen®).

Route of administration: subcutaneous
Experimental: Insulin glargine

Insulin glargine is self-administered once daily in the morning within one hour before breakfast. Treatment will be initiated and individually adjusted weekly according to fasting self measured plasma glucose (SMPG) (target fasting SMPG between 80 and 100 mg/dl (4.4 and 5.6 mmol/l).

Subjects should continue their pre-trial treatment with metformin.

 Drug: Insulin glargine (HOE901)

Pharmaceutical form:Solution for injection using a disposable self injector device (Lantus® SoloSTAR®).

Route of administration: subcutaneous

Detailed Description:

Approximately 27 weeks including a 24-week treatment period

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patient with type 2 diabetes mellitus diagnosed for at least 1 year.
  • Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening.

Exclusion criteria:

  • Age < legal age of adulthood
  • Screening HbA1c < 7% or > 10%
  • Screening FPG > 250 mg/dL (> 13.9 mmol/L)
  • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
  • Type 1 diabetes mellitus
  • Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening
  • Use of insulin within the last 6 months
  • Previous use of insulin, except for episode(s) of short-term treatment (≤ 15 consecutive days) due to intercurrent illness
  • Amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN) at screening
  • Calcitonin ≥ 20 pg/ml (5.9 pmol/l) at screening
  • Alanine Transferase (ALT)> 3ULN 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)
  • Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure >180 mmHg or >110 mmHg, respectively
  • Within the last 6 months prior to screening: history of heart failure requiring hospitalization, myocardial infarction, or stroke. Planned coronary, carotid or peripheral artery revascularisation procedures
  • Body Mass Index (BMI) ≤ 20 or > 40 kg/m²
  • Any previous treatment with lixisenatide

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476475

  Hide Study Locations
Locations
United States, Arkansas
Investigational Site Number 840408
Little Rock, Arkansas, United States, 72205
United States, California
Investigational Site Number 840412
Paramount, California, United States, 90723
United States, Georgia
Investigational Site Number 840401
Larenceville, Georgia, United States, 30045
Investigational Site Number 840417
Roswell, Georgia, United States, 30076
United States, Kentucky
Investigational Site Number 840403
Lexington, Kentucky, United States, 40504
United States, Maryland
Investigational Site Number 840404
Hyattsville, Maryland, United States, 20782
Investigational Site Number 840405
Rockville, Maryland, United States, 20852
United States, Nevada
Investigational Site Number 840411
Las Vegas, Nevada, United States, 89148
United States, New York
Investigational Site Number 840415
West Seneca, New York, United States, 14224
United States, Oklahoma
Investigational Site Number 840402
Norman, Oklahoma, United States, 73069
United States, Oregon
Investigational Site Number 840407
Medford, Oregon, United States, 97504
United States, Pennsylvania
Investigational Site Number 840413
Durham, Pennsylvania, United States, 27713
United States, Texas
Investigational Site Number 840410
Dallas, Texas, United States, 75230
United States, Washington
Investigational Site Number 840414
Renton, Washington, United States, 98055
Chile
Investigational Site Number 152401
Santiago, Chile, 7980378
Investigational Site Number 152402
Santiago, Chile, 8320000
Investigational Site Number 152404
Santiago, Chile, 7500347
Investigational Site Number 152403
Santiago, Chile, 7500710
Investigational Site Number 152405
Santiago, Chile, 7500347
Czech Republic
Investigational Site Number 203403
Novy Jicin, Czech Republic, 74101
Investigational Site Number 203401
Plzen, Czech Republic, 32600
Investigational Site Number 203402
Praha 2, Czech Republic, 12808
Investigational Site Number 203405
Praha 8, Czech Republic, 18100
Denmark
Investigational Site Number 208401
København Nv, Denmark, 2400
Investigational Site Number 208404
Køge, Denmark, 4600
Investigational Site Number 208402
Slagelse, Denmark, 4200
Investigational Site Number 208403
Svendborg, Denmark, 5700
France
Investigational Site Number 250402
Narbonne, France, 11018
Investigational Site Number 250404
Poitiers Cedex, France, 86021
Investigational Site Number 250401
Vandoeuvre Les Nancy, France, 54511
Germany
Investigational Site Number 276401
Dresden, Germany, 01307
Investigational Site Number 276402
Ludwigshafen, Germany, 67059
Investigational Site Number 276403
Oberhausen, Germany, 46045
Hungary
Investigational Site Number 348401
Balatonfüred, Hungary, 8230
Investigational Site Number 348405
Budapest, Hungary, 1041
Investigational Site Number 348406
Budapest, Hungary, 1212
Investigational Site Number 348404
Debrecen, Hungary, 4043
Investigational Site Number 348403
Szeged, Hungary, 6722
Investigational Site Number 348402
Szeged, Hungary, 6720
Lithuania
Investigational Site Number 440401
Kaunas, Lithuania, LT-49456
Investigational Site Number 440402
Kaunas, Lithuania, LT-51270
Investigational Site Number 440403
Kedainiai, Lithuania, LT-57164
Investigational Site Number 440404
Klaipeda, Lithuania, LT-92304
Mexico
Investigational Site Number 484404
Acapulco, Mexico, 39670
Investigational Site Number 484401
Cuernavaca, Mexico, 62250
Investigational Site Number 484405
Durango, Mexico, 34270
Investigational Site Number 484403
Guadalajara, Mexico, 44656
Investigational Site Number 484402
Guadalajara, Mexico, 44210
Poland
Investigational Site Number 616405
Bialystok, Poland, 15-435
Investigational Site Number 616406
Gdansk, Poland, 80-847
Investigational Site Number 616403
Krakow, Poland, 31-548
Investigational Site Number 616407
Lodz, Poland, 94-074
Investigational Site Number 616404
Pulawy, Poland, 24-100
Investigational Site Number 616402
Szczecin, Poland, 70-506
Investigational Site Number 616401
Warszawa, Poland, 02-507
Romania
Investigational Site Number 642402
Brasov, Romania, 500365
Investigational Site Number 642403
Bucuresti, Romania, 020475
Investigational Site Number 642405
Iasi, Romania, 700547
Investigational Site Number 642401
Oradea, Romania, 410169
Investigational Site Number 642406
Targu Mures, Romania, 540142
Investigational Site Number 642404
Timisoara, Romania, 300133
Slovakia
Investigational Site Number 703402
Bratislava, Slovakia, 85101
Investigational Site Number 703403
Kosice, Slovakia, 04001
Investigational Site Number 703406
Kosice, Slovakia, 04013
Investigational Site Number 703404
Moldava Nad Bodvou, Slovakia, 04525
Investigational Site Number 703405
Nitra, Slovakia, 94911
Investigational Site Number 703401
Zilina, Slovakia, 01001
Sweden
Investigational Site Number 752402
Skellefteå, Sweden, 931 32
Investigational Site Number 752401
Stockholm, Sweden, 171 76
Investigational Site Number 752403
Växjö, Sweden, 351 85
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01476475     History of Changes
Other Study ID Numbers: ACT12374, 2011-002090-36, U1111-1121-7111
Study First Received: November 4, 2011
Last Updated: January 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013