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NCT01512979 · ClinicalTrials.gov registry record · Phase 4
Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes
A Phase 4 study of Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 316
- Enrollment target
- 20
- Study locations
NCT01512979: Completed Phase 4 study of Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim.
NCT01512979 is a Phase 4 study of Diabetes Mellitus, Type 2 that has completed, run by Boehringer Ingelheim. The registered enrollment target is 316 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01512979, a Phase 4 study of Diabetes Mellitus, Type 2, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 316 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes.
Primary Outcome
HbA1c is measured as a percentage. The change from baseline is the Week 24 HbA1c minus the baseline HbA1c. Means are adjusted for treatment and continuous baseline HbA1c
Conditions Studied
Interventions
- DRUG metformin
- DRUG linagliptin
- DRUG metformin placebo
Study Locations (20)
California
- 1218.83.11011 Boehringer Ingelheim Investigational Site - Chino
- 1218.83.11001 Boehringer Ingelheim Investigational Site - Huntington Beach
- 1218.83.11019 Boehringer Ingelheim Investigational Site - Huntington Park
- 1218.83.11015 Boehringer Ingelheim Investigational Site - Lomita
- 1218.83.11023 Boehringer Ingelheim Investigational Site - Norwalk
- 1218.83.11014 Boehringer Ingelheim Investigational Site - Roseville
- 1218.83.11031 Boehringer Ingelheim Investigational Site - San Diego
Florida
- 1218.83.11022 Boehringer Ingelheim Investigational Site - Fort Lauderdale
- 1218.83.11025 Boehringer Ingelheim Investigational Site - Orlando
- 1218.83.11033 Boehringer Ingelheim Investigational Site - Sanford
North Carolina
- 1218.83.11013 Boehringer Ingelheim Investigational Site - Jacksonville
- 1218.83.11028 Boehringer Ingelheim Investigational Site - Salisbury
- 1218.83.11009 Boehringer Ingelheim Investigational Site - Shelby
Arizona
- 1218.83.11002 Boehringer Ingelheim Investigational Site - Phoenix
Arkansas
- 1218.83.11036 Boehringer Ingelheim Investigational Site - Little Rock
Georgia
- 1218.83.11029 Boehringer Ingelheim Investigational Site - Oakwood
Kentucky
- 1218.83.11026 Boehringer Ingelheim Investigational Site - Owensboro
Maryland
- 1218.83.11008 Boehringer Ingelheim Investigational Site - Elkton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-04 |
| Phase | Phase 4 |
What the finished NCT01512979 record still lists
NCT01512979 is an interventional study that assigns participants to a tested intervention. The registered 316 participants enrollment target is mid-sized for trials with a published cap, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 3 interventions - of which metformin is the first listed.
NCT01512979 names 20 study sites across 10 states, led by California, Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01512979 about?
NCT01512979 is a clinical study titled "Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes". The purpose of this trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes.
What is the current status of trial NCT01512979?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 316 participants. The study started on 2012-01. Estimated completion is 2013-04.
What conditions does trial NCT01512979 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT01512979?
The interventions under investigation include: metformin (DRUG), linagliptin (DRUG), metformin placebo (DRUG).
Who is sponsoring clinical trial NCT01512979?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01512979 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. 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 NCT01512979's enrollment target sits among peer trials
316 118th of 348 higher than 231 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.
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