# Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

> **NCT01632163** · PHASE3 · COMPLETED · sponsor: **Sanofi** · enrollment: 447 (actual)

## Conditions studied

- Type 2 Diabetes Mellitus

## Interventions

- **DRUG:** Lixisenatide (AVE0010)
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT01632163
- **Lead sponsor:** Sanofi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-10
- **Primary completion:** 2015-05
- **Final completion:** 2015-05
- **Target enrollment:** 447 (ACTUAL)
- **Last updated:** 2015-06-15


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01632163

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01632163, "Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT01632163. Licensed CC0.

---

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