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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 27, 2014
Last verified: January 2014

November 4, 2011
January 27, 2014
November 2011
December 2012   (final data collection date for primary outcome measure)
Change in HbA1c [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01476475 on ClinicalTrials.gov Archive Site
  • Change in 2-hour post-prandial plasma glucose (PPG) during meal test [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in 2-hour plasma 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 ]
  • Change in 30-minute and 1-hour PPG and plasma glucose excursion during meal test [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Percentage of patients reaching HbA1c <7% at week 24 with no documented symptomatic hypoglycemia during the 24-week open label treatment period [ Time Frame: over the 24-week treatment period ] [ Designated as safety issue: No ]
  • Percentage of patients reaching HbA1c <7% with no weight gain [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients
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

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.

Approximately 27 weeks including a 24-week treatment period

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Insulin glargine /lixisenatide fixed ratio combination (HOE901/AVE0010)

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • Drug: Insulin glargine (HOE901)

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • Drug: Metformin
    Route of administration: oral
  • Device: re-usable pen-type self-injector device
    Other Name: Tactipen®
  • Device: disposable self injector device
    Other Name: Lantus® SoloSTAR®
  • Experimental: Insulin glargine /lixisenatide fixed ratio 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.

    Interventions:
    • Drug: Insulin glargine /lixisenatide fixed ratio combination (HOE901/AVE0010)
    • Drug: Metformin
    • Device: re-usable pen-type self-injector device
  • Active Comparator: 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.

    Interventions:
    • Drug: Insulin glargine (HOE901)
    • Drug: Metformin
    • Device: disposable self injector device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
323
December 2012
December 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Chile,   Czech Republic,   Denmark,   France,   Germany,   Hungary,   Lithuania,   Mexico,   Poland,   Romania,   Slovakia,   Sweden
 
NCT01476475
ACT12374, 2011-002090-36, U1111-1121-7111
Yes
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP