CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 446 enrolled
Drug / intervention
Lixisenatide (AVE0010) +5 moredrug
Likely dose
Insulin glargine 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00975286
NCT00975286Phase 3Completed
CompareCT.gov

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

Sanofi·interventional·Posted Sep 11, 2009·Updated Oct 11, 2016

In Brief

A Phase 3 clinical trial evaluating Lixisenatide (AVE0010), Placebo, and 4 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 446 participants across 140 sites in 26 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesArgentina, Brazil, Canada, Chile, Colombia, Czechia, Denmark, Estonia, France, Germany, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russia, South Africa, Sweden, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 11, 2009
Enrollment StartOct 1, 2009
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.8 years ago

Interventions

Lixisenatide (AVE0010)drug

Self administered by subcutaneous injections once daily within the hour preceding breakfast.

Placebodrug

Self administered by subcutaneous injections once daily within the hour preceding breakfast.

Insulin glarginedrug

Dose to be adjusted to maintain a fasting SMPG between 100 and 80 mg/dL (5.6 and 4.4 mmol/L), inclusive.

Pen auto-injectordevice

Lantus® SoloStar® OptiClik®

Metformindrug

Metformin to be continued at stable dose (at least 1.5 gram per day) up to Week 24.

Thiazolidinedione (TZD)drug

TZD (either rosiglitazone or pioglitazone) if given, to be continued at stable dose up to Week 24.