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NCT00751114 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients
A Phase 4 study of Diabetes Mellitus, Type 2, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 515
- Enrollment target
- 17
- Study locations
NCT00751114: Completed Phase 4 study of Diabetes Mellitus, Type 2, sponsored by Sanofi.
NCT00751114 is a Phase 4 study of Diabetes Mellitus, Type 2 that has completed, run by Sanofi. The registered enrollment target is 515 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (89% lower). The trial reports 17 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00751114, a Phase 4 study of Diabetes Mellitus, Type 2, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 515 participants
- Enrollment target
- 17
- Study locations
Study Summary
The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period. Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on: * HbA1c level * Fasting Plasma Glucose (FPG) * 7-point plasma glucose (PG) profiles * Percentage of patients with HbA1c \<7% and \<6.5% Safety objectives consisted of: * Hypoglycemia occurrence * Body weight * Overall safety
Primary Outcome
Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period.
Conditions Studied
Interventions
- DRUG Metformin
- DRUG Sitagliptin
- DRUG Insulin Glargine
Study Locations (17)
Other
- Sanofi-Aventis Administrative Office - Vienna
- Sanofi-Aventis Administrative Office - São Paulo
- Sanofi-Aventis Administrative Office - Bogotá
- Sanofi-Aventis Administrative Office - Cairo
- Sanofi-Aventis Administrative Office - Kallithea
- Sanofi-Aventis Administrative Office - Hong Kong
- Sanofi-Aventis Administrative Office - Mumbai
- Sanofi-Aventis Administrative Office - Netanya
- Sanofi-Aventis Administrative Office - Beirut
- Sanofi-Aventis Administrative Office - Col. Coyoacan
- Sanofi-Aventis Administrative Office - Gouda
- Sanofi-Aventis Administrative Office - Porto Salvo
- Sanofi-Aventis Administrative Office - Seoul
- Sanofi-Aventis Administrative Office - Barcelona
- Sanofi-Aventis Administrative Office - Istanbul
- Sanofi-Aventis Administrative Office - Guildford Surrey
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 515 participants |
| Start Date | 2008-11 |
| Est. Completion | 2011-07 |
| Phase | Phase 4 |
What the finished NCT00751114 record still lists
NCT00751114 is an interventional study that assigns participants to a tested intervention. The registered 515 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 (89% 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.
NCT00751114 lists 17 locations in 2 states (Other, New Jersey).
Frequently Asked Questions
What is clinical trial NCT00751114 about?
NCT00751114 is a clinical study titled "Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients". The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period. Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on: * HbA1...
What is the current status of trial NCT00751114?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 515 participants. The study started on 2008-11. Estimated completion is 2011-07.
What conditions does trial NCT00751114 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT00751114?
The interventions under investigation include: Metformin (DRUG), Sitagliptin (DRUG), Insulin Glargine (DRUG).
Who is sponsoring clinical trial NCT00751114?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00751114 being conducted?
This trial has 17 study locations across New Jersey. 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 NCT00751114's enrollment target sits among peer trials
515 72nd of 348 higher than 277 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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