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NCT00881530 · ClinicalTrials.gov registry record · Phase 2
Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 660
- Enrollment target
NCT00881530: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT00881530 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 660 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (396% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00881530, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 660 participants
- Enrollment target
Study Summary
The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.
Primary Outcome
Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration: * Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L) * Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L) * Documented symptomatic hypoglycemia with glucose of \<54 mg/dL (\<3.0 mmol/L): the event was
Interventions
- DRUG Metformin
- DRUG Sitagliptin
- DRUG BI 10773
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2009-03 |
| Phase | Phase 2 |
What the finished NCT00881530 record still lists
NCT00881530 is an interventional study that assigns participants to a tested intervention. The registered 660 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (396% higher).
The record links to 0 conditions, and to 3 interventions - of which Metformin is the first listed.
NCT00881530 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00881530 about?
NCT00881530 is a clinical study titled "Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension". The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.
What is the current status of trial NCT00881530?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 660 participants. The study started on 2009-03.
What interventions are being tested in trial NCT00881530?
The interventions under investigation include: Metformin (DRUG), Sitagliptin (DRUG), BI 10773 (DRUG).
Who is sponsoring clinical trial NCT00881530?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00881530's enrollment target sits among peer trials
660 49th of 2000 higher than 1,951 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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