# Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients

> **NCT01422876** · PHASE3 · COMPLETED · sponsor: **Boehringer Ingelheim** · enrollment: 1405 (actual)

## Conditions studied

- Diabetes Mellitus, Type 2

## Interventions

- **DRUG:** high dose FDC
- **DRUG:** BI 10773 high dose
- **DRUG:** high dose FDC placebo
- **DRUG:** low dose FDC placebo
- **DRUG:** high dose FDC placebo
- **DRUG:** high dose FDC placebo
- **DRUG:** low dose FDC placebo
- **DRUG:** low dose FDC placebo
- **DRUG:** high dose BI 10773 placebo
- **DRUG:** low dose FDC
- **DRUG:** high dose FDC placebo
- **DRUG:** BI 10773 low dose
- **DRUG:** high dose BI 10773 placebo
- **DRUG:** high dose BI 10773 placebo
- **DRUG:** linagliptin
- **DRUG:** low dose FDC placebo
- **DRUG:** linagliptin placebo
- **DRUG:** BI 10773 low dose placebo
- **DRUG:** linagliptin placebo
- **DRUG:** low dose BI 10773 placebo

## Key facts

- **NCT ID:** NCT01422876
- **Lead sponsor:** Boehringer Ingelheim
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-08
- **Primary completion:** 2013-09
- **Final completion:** 2013-09
- **Target enrollment:** 1405 (ACTUAL)
- **Last updated:** 2015-04-02

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01422876

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01422876, "Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01422876. Licensed CC0.

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