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NCT00972283 · ClinicalTrials.gov registry record · Phase 3
Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes
A Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,006
- Enrollment target
- 20
- Study locations
NCT00972283: Completed Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.
NCT00972283 is a Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes that has completed, run by Novo Nordisk A/S. The registered enrollment target is 1,006 participants, below the 4,482-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00972283, a Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,006 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is conducted in Africa, Asia, Europe, and the United States of America (USA). The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type 2 diabetes (main period) followed by investigating the long-term safety in terms of comparing NN1250 with insulin glargine plus insulin aspart with or without metformin and with or without pioglitazone in subjects with type 2 diabetes. All oral anti-diabetic drug (OAD) treatment will be discontinued, if applicable, when trial participant enters the trial (NN1250-3582) with the exception of metformin and pioglitazone. Subjects who consent to participate in the extension trial (NN1250-3667) will continue to receive the treatment to which they were randomly allocated in the 52 week trial NN1250-3582. The main period is registered internally at Novo Nordisk as NN1250-3582 while the extension period is registered as NN1250-3667.
Primary Outcome
Change from baseline in HbA1c after 52 weeks of treatment
Conditions Studied
Interventions
- DRUG insulin aspart
- DRUG insulin glargine
- DRUG insulin degludec
Study Locations (20)
California
- Novo Nordisk Investigational Site - Anaheim
- Novo Nordisk Investigational Site - Huntington Beach
- Novo Nordisk Investigational Site - Los Gatos
- Novo Nordisk Investigational Site - Salinas
- Novo Nordisk Investigational Site - Santa Monica
- Novo Nordisk Investigational Site - Spring Valley
- Novo Nordisk Investigational Site - Tustin
- Novo Nordisk Investigational Site - Walnut Creek
Florida
- Novo Nordisk Investigational Site - Gainesville
- Novo Nordisk Investigational Site - Jacksonville
- Novo Nordisk Investigational Site - Lake Mary
- Novo Nordisk Investigational Site - Orlando
Connecticut
- Novo Nordisk Investigational Site - Milford
- Novo Nordisk Investigational Site - Norwalk
- Novo Nordisk Investigational Site - Waterbury
Alabama
- Novo Nordisk Investigational Site - Alexander City
- Novo Nordisk Investigational Site - Birmingham
Arizona
- Novo Nordisk Investigational Site - Goodyear
- Novo Nordisk Investigational Site - Peoria
District of Columbia
- Novo Nordisk Investigational Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,006 participants |
| Start Date | 2009-09-01 |
| Est. Completion | 2010-10-28 |
| Phase | Phase 3 |
What the finished NCT00972283 record still lists
NCT00972283 is an interventional study that assigns participants to a tested intervention. Its 1,006 participants enrollment target places it among the larger protocols in the corpus, below the 4,482-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 3 interventions - of which insulin aspart is the first listed.
NCT00972283 names 20 study sites across 6 states, led by California, Florida, Connecticut.
Frequently Asked Questions
What is clinical trial NCT00972283 about?
NCT00972283 is a clinical study titled "Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes". This trial is conducted in Africa, Asia, Europe, and the United States of America (USA). The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) plus insulin aspart (IAsp) with/without metformin and with/without pioglitazone in subjects with type ...
What is the current status of trial NCT00972283?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,006 participants. The study started on 2009-09-01. Estimated completion is 2010-10-28.
What conditions does trial NCT00972283 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes.
What interventions are being tested in trial NCT00972283?
The interventions under investigation include: insulin aspart (DRUG), insulin glargine (DRUG), insulin degludec (DRUG).
Who is sponsoring clinical trial NCT00972283?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00972283 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT00972283's enrollment target sits among peer trials
1,006 36th of 348 higher than 313 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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