# Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin

> **NCT01169779** · PHASE3 · COMPLETED · sponsor: **Sanofi** · enrollment: 391 (actual)

## Conditions studied

- Type 2 Diabetes Mellitus

## Interventions

- **DRUG:** Lixisenatide (AVE0010)
- **DRUG:** Placebo
- **DEVICE:** Pen auto-injector
- **DRUG:** Metformin
- **DRUG:** Sulfonylurea

## Key facts

- **NCT ID:** NCT01169779
- **Lead sponsor:** Sanofi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-07
- **Primary completion:** 2011-12
- **Final completion:** 2011-12
- **Target enrollment:** 391 (ACTUAL)
- **Last updated:** 2016-10-13


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01169779

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01169779, "Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT01169779. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
