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A Randomized, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Double-blind Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine and Metformin
The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment. The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (\<) 7 percent (%) and less than or equal to (\<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.
The study comprises 3 periods: * An up to 14-week screening period, which includes an up to 2-week screening phase and a 12-week run-in phase with introduction and titration of insulin glargine on top of metformin +/-TZDs. * At the end of the run-in phase, patients whose HbA1c (centralized assay) is greater than or equal to (\>=) 7% and less than or equal to (\<=) 9% and whose mean fasting self-monitored plasma glucose (SMPG) calculated from the self measurements for the 7 days prior to Visit 12 (Week -1) is \<=140 milligram per deciliter (mg/dL) (7.8 millimole per liter \[mmol/L\]), would enter a 24-week double-blind randomized treatment period comparing lixisenatide to placebo (on top of insulin glargine + metformin +/- TZDs). * A 3-day safety follow up period. Maximum duration is of 39 weeks +/- 7 days.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Sanofi-Aventis Investigational Site Number 840223
Mesa, Arizona, United States
Sanofi-Aventis Investigational Site Number 840206
Hot Springs, Arkansas, United States
Sanofi-Aventis Investigational Site Number 840201
Little Rock, Arkansas, United States
Sanofi-Aventis Investigational Site Number 840212
Mountain Home, Arkansas, United States
Sanofi-Aventis Investigational Site Number 840215
Concord, California, United States
Sanofi-Aventis Investigational Site Number 840214
Greenbrae, California, United States
Sanofi-Aventis Investigational Site Number 840221
Orlando, Florida, United States
Sanofi-Aventis Investigational Site Number 840211
Baton Rouge, Louisiana, United States
Sanofi-Aventis Investigational Site Number 840230
Hyattsville, Maryland, United States
Sanofi-Aventis Investigational Site Number 840209
Rockville, Maryland, United States
Start Date
October 1, 2009
Primary Completion Date
August 1, 2011
Completion Date
August 1, 2011
Last Updated
October 11, 2016
446
ACTUAL participants
Lixisenatide (AVE0010)
DRUG
Placebo
DRUG
Insulin glargine
DRUG
Pen auto-injector
DEVICE
Metformin
DRUG
Thiazolidinedione (TZD)
DRUG
Lead Sponsor
Sanofi
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07433062