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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

  Show 70 Study Locations
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 May 16, 2013