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NCT00954447 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,263
- Enrollment target
NCT00954447: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00954447 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,263 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00954447, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,263 participants
- Enrollment target
Study Summary
The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Primary Outcome
HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)
Interventions
- DRUG Placebo
- DRUG Linagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,263 participants |
| Start Date | 2009-08 |
| Phase | Phase 3 |
What the finished NCT00954447 record still lists
NCT00954447 is an interventional study that assigns participants to a tested intervention. Its 1,263 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 (64% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00954447 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00954447 about?
NCT00954447 is a clinical study titled "Efficacy and Safety of Linagliptin in Combination With Insulin in Patients With Type 2 Diabetes". The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to Placebo during long term treatment (52 weeks and longer) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic c...
What is the current status of trial NCT00954447?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,263 participants. The study started on 2009-08.
What interventions are being tested in trial NCT00954447?
The interventions under investigation include: Placebo (DRUG), Linagliptin (DRUG).
Who is sponsoring clinical trial NCT00954447?
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 NCT00954447's enrollment target sits among peer trials
1,263 204th of 2000 higher than 1,797 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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