Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01632163
First received: June 26, 2012
Last updated: October 13, 2014
Last verified: October 2014

June 26, 2012
October 13, 2014
October 2012
May 2015   (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 NCT01632163 on ClinicalTrials.gov Archive Site
  • Percentage of patients with HbA1c <7%, =<6.5% [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Change in 2-hour postprandial plasma glucose and plasma glucose excursion [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in 7-point self monitoring plasma glucose profile (average and each point) [ 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 ]
  • Change in daily basal insulin dose [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Anti-lixisenatide antibody assessment [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin
A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Metformin

Primary Objective:

- To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients.

Secondary Objectives:

  • To assess the effects of lixisenatide over 24 weeks on :

    • percentage of patients reaching HbA1c<7% or ≤6.5%,
    • 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test,
    • fasting plasma glucose (FPG),
    • change in 7-point self-monitored plasma glucose (SMPG) profile),
    • body weight,
    • change in daily basal insulin dose.
  • To assess lixisenatide safety and tolerability.
  • To assess anti-lixisenatide antibody development.

Maximum study duration of approximately 35 weeks ± 9 days (up to 2 weeks screening + 8 weeks run-in + 24 weeks double-blind treatment+ 3 days follow-up)

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Lixisenatide (AVE0010)

    Pharmaceutical form:solution

    Route of administration: subcutaneous injection

  • Drug: Placebo

    Pharmaceutical form:solution

    Route of administration: subcutaneous injection

  • Experimental: Lixisenatide
    24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day)
    Intervention: Drug: Lixisenatide (AVE0010)
  • Placebo Comparator: Placebo
    24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
432
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion criteria :

- Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year at the time of the screening visit insufficiently controlled with basal insulin± metformin.

Exclusion criteria:

At screening:

  • Age < legal age of adulthood.
  • HbA1c<7% or >10.5%.
  • Basal insulin treatment has not been at a stable regimen for at least 3 months and at a stable dose (± 20%) of at least 15 U/day for at least 2 months prior to screening visit.
  • If metformin is given, metformin treatment has not been at a stable dose of at least 1.0 g/day for at least 3 months prior to screening visit.
  • History of hypoglycemia unawareness.
  • Body Mass Index (BMI) ≤20 kg/m².
  • Use of other oral or injectable glucose-lowering agents other than basal insulin or metformin within 3 months prior to the time of screening.

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: For site information, send an email with site number to Contact-Us@sanofi.com
China,   India,   Korea, Republic of,   Russian Federation
 
NCT01632163
EFC12382, U1111-1124-1213
Yes
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
October 2014

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