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

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ClinicalTrials.gov Identifier: NCT01632163
Recruitment Status : Completed
First Posted : July 2, 2012
Last Update Posted : June 15, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Lixisenatide (AVE0010) Drug: Placebo Phase 3

Detailed Description:
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)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 447 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2012
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lixisenatide
24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day)
Drug: Lixisenatide (AVE0010)

Pharmaceutical form:solution

Route of administration: subcutaneous injection

Placebo Comparator: Placebo
24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day)
Drug: Placebo

Pharmaceutical form:solution

Route of administration: subcutaneous injection



Outcome Measures

Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: from baseline to week 24 ]

Secondary Outcome Measures :
  1. Percentage of patients with HbA1c <7%, =<6.5% [ Time Frame: at week 24 ]
  2. Change in 2-hour postprandial plasma glucose and plasma glucose excursion [ Time Frame: from baseline to week 24 ]
  3. Change in fasting plasma glucose [ Time Frame: from baseline to week 24 ]
  4. Change in 7-point self monitoring plasma glucose profile (average and each point) [ Time Frame: from baseline to week 24 ]
  5. Change in body weight [ Time Frame: from baseline to week 24 ]
  6. Change in daily basal insulin dose [ Time Frame: from baseline to week 24 ]
  7. Number of patients with adverse events [ Time Frame: 24 weeks ]
  8. Anti-lixisenatide antibody assessment [ Time Frame: from baseline to week 24 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632163


  Show 51 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01632163     History of Changes
Other Study ID Numbers: EFC12382
U1111-1124-1213 ( Other Identifier: UTN )
First Posted: July 2, 2012    Key Record Dates
Last Update Posted: June 15, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Lixisenatide
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs