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NCT01232491 · ClinicalTrials.gov registry record · Phase 4
Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes
A Phase 4 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 4
- Development phase
- 611
- Enrollment target
- 20
- Study locations
NCT01232491: Completed Phase 4 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.
NCT01232491 is a Phase 4 study of Diabetes Mellitus, Type 2 and Diabetes that has completed, run by Novo Nordisk A/S. The registered enrollment target is 611 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01232491, a Phase 4 study of Diabetes Mellitus, Type 2 and Diabetes, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 611 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is conducted in Europe, and North and South America. The aim of this trial is to investigate if a dietary intervention has an effect on weight when initiating insulin treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs (OADs).
Primary Outcome
Estimated mean change from baseline in body weight after 26 weeks of treatment.
Conditions Studied
Interventions
- DRUG Insulin detemir
- DIETARY_SUPPLEMENT Dietary regimen
Study Locations (20)
California
- Novo Nordisk Investigational Site - Anaheim
- Novo Nordisk Investigational Site - Burlingame
- Novo Nordisk Investigational Site - Concord
- Novo Nordisk Investigational Site - Fullerton
- Novo Nordisk Investigational Site - Long Beach
- Novo Nordisk Investigational Site - Long Beach
- Novo Nordisk Investigational Site - Long Beach
- Novo Nordisk Investigational Site - Montclair
- Novo Nordisk Investigational Site - National City
- Novo Nordisk Investigational Site - Redlands
- Novo Nordisk Investigational Site - Santa Ana
- Novo Nordisk Investigational Site - Spring Valley
- Novo Nordisk Investigational Site - Walnut Creek
Florida
- Novo Nordisk Investigational Site - Bradenton
- Novo Nordisk Investigational Site - Clearwater
- Novo Nordisk Investigational Site - Jacksonville
Alabama
- Novo Nordisk Investigational Site - Birmingham
- Novo Nordisk Investigational Site - Ozark
Colorado
- Novo Nordisk Investigational Site - Colorado Springs
Connecticut
- Novo Nordisk Investigational Site - Norwalk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 611 participants |
| Start Date | 2010-10-29 |
| Est. Completion | 2011-11-14 |
| Phase | Phase 4 |
What the finished NCT01232491 record still lists
NCT01232491 is an interventional study that assigns participants to a tested intervention. The registered 611 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 (86% lower).
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Insulin detemir is the first listed.
NCT01232491 names 20 study sites across 5 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT01232491 about?
NCT01232491 is a clinical study titled "Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes". This trial is conducted in Europe, and North and South America. The aim of this trial is to investigate if a dietary intervention has an effect on weight when initiating insulin treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs (OADs).
What is the current status of trial NCT01232491?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 611 participants. The study started on 2010-10-29. Estimated completion is 2011-11-14.
What conditions does trial NCT01232491 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes.
What interventions are being tested in trial NCT01232491?
The interventions under investigation include: Insulin detemir (DRUG), Dietary regimen (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01232491?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01232491 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. 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 NCT01232491's enrollment target sits among peer trials
611 63rd of 348 higher than 286 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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