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NCT00622284 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,560
- Enrollment target
NCT00622284: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00622284 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,560 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (102% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00622284, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,560 participants
- Enrollment target
Study Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
Primary Outcome
This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.
Interventions
- DRUG Glimepiride
- DRUG BI 1356
- DRUG Placebo identical to BI 1356 5mg
- DRUG Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,560 participants |
| Start Date | 2008-02 |
| Phase | Phase 3 |
What the finished NCT00622284 record still lists
NCT00622284 is an interventional study that assigns participants to a tested intervention. Its 1,560 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (102% higher).
The record links to 0 conditions, and to 4 interventions - of which Glimepiride is the first listed.
NCT00622284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00622284 about?
NCT00622284 is a clinical study titled "Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes". The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
What is the current status of trial NCT00622284?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,560 participants. The study started on 2008-02.
What interventions are being tested in trial NCT00622284?
The interventions under investigation include: Glimepiride (DRUG), BI 1356 (DRUG), Placebo identical to BI 1356 5mg (DRUG), Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg (DRUG).
Who is sponsoring clinical trial NCT00622284?
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 NCT00622284's enrollment target sits among peer trials
1,560 150th of 2000 higher than 1,851 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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