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NCT00800683 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 133
- Enrollment target
- 20
- Study locations
NCT00800683: Completed Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim.
NCT00800683 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Boehringer Ingelheim. The registered enrollment target is 133 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00800683, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 133 participants
- Enrollment target
- 20
- Study locations
Study Summary
to determine safety, efficacy and tolerability of BI 1356 versus placebo
Primary Outcome
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Conditions Studied
Interventions
- DRUG placebo
- DRUG BI 1356
Study Locations (20)
California
- 1218.43.10011 Boehringer Ingelheim Investigational Site - Chula Vista
- 1218.43.10006 Boehringer Ingelheim Investigational Site - Riverside
- 1218.43.10021 Boehringer Ingelheim Investigational Site - Whittier
Florida
- 1218.43.10013 Boehringer Ingelheim Investigational Site - Pembroke Pines
- 1218.43.10009 Boehringer Ingelheim Investigational Site - West Palm Beach
New York
- 1218.43.10003 Boehringer Ingelheim Investigational Site - Great Neck
- 1218.43.10004 Boehringer Ingelheim Investigational Site - The Bronx
Ohio
- 1218.43.10019 Boehringer Ingelheim Investigational Site - Delaware
- 1218.43.10008 Boehringer Ingelheim Investigational Site - Mentor
Pennsylvania
- 1218.43.10005 Boehringer Ingelheim Investigational Site - Bethlehem
- 1218.43.10007 Boehringer Ingelheim Investigational Site - Carlisle
Arizona
- 1218.43.10027 Boehringer Ingelheim Investigational Site - Phoenix
Georgia
- 1218.43.10018 Boehringer Ingelheim Investigational Site - Decatur
Illinois
- 1218.43.10022 Boehringer Ingelheim Investigational Site - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2008-12 |
| Phase | Phase 3 |
What the finished NCT00800683 record still lists
NCT00800683 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00800683 names 20 study sites across 14 states, led by California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT00800683 about?
NCT00800683 is a clinical study titled "Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive". to determine safety, efficacy and tolerability of BI 1356 versus placebo
What is the current status of trial NCT00800683?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 133 participants. The study started on 2008-12.
What conditions does trial NCT00800683 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT00800683?
The interventions under investigation include: placebo (DRUG), BI 1356 (DRUG).
Who is sponsoring clinical trial NCT00800683?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00800683 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00800683's enrollment target sits among peer trials
133 183rd of 348 higher than 166 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 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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