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.
Verified April 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01632163
First received: June 26, 2012
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: Lixisenatide (AVE0010)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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:
  • 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 ]

Estimated Enrollment: 432
Study Start Date: October 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632163

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Show 48 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01632163     History of Changes
Other Study ID Numbers: EFC12382, U1111-1124-1213
Study First Received: June 26, 2012
Last Updated: April 2, 2014
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014