# Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients

> **NCT01768559** · PHASE3 · COMPLETED · sponsor: **Sanofi** · enrollment: 894 (actual)

## Conditions studied

- Type 2 Diabetes

## Interventions

- **DRUG:** Lixisenatide (AVE0010)
- **DRUG:** Insulin glulisine QD
- **DRUG:** Insulin glulisine TID
- **DRUG:** Insulin Glargine (Mandatory background drug)
- **DRUG:** Metformin (Background drug)

## Key facts

- **NCT ID:** NCT01768559
- **Lead sponsor:** Sanofi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2013-01
- **Primary completion:** 2014-12
- **Final completion:** 2014-12
- **Target enrollment:** 894 (ACTUAL)
- **Last updated:** 2017-01-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01768559

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01768559, "Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01768559. Licensed CC0.

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