# Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus Uncontrolled on Oral Antihyperglycemic Drugs

> **NCT04980027** · PHASE4 · COMPLETED · sponsor: **Sanofi** · enrollment: 228 (actual)

## Conditions studied

- Type 2 Diabetes Mellitus

## Interventions

- **DRUG:** Insulin glargine (U300)

## Key facts

- **NCT ID:** NCT04980027
- **Lead sponsor:** Sanofi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2021-06-07
- **Primary completion:** 2022-12-23
- **Final completion:** 2022-12-23
- **Target enrollment:** 228 (ACTUAL)
- **Last updated:** 2025-09-22


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04980027

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04980027, "Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus Uncontrolled on Oral Antihyperglycemic Drugs". Retrieved via AI Analytics 2026-07-10 from https://api.ai-analytics.org/clinical/NCT04980027. Licensed CC0.

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