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NCT00467649 · ClinicalTrials.gov registry record · Phase 4
A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
A Phase 4 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 4
- Development phase
- 112
- Enrollment target
NCT00467649: Completed Phase 4 study, sponsored by AstraZeneca.
NCT00467649 is a Phase 4 study that has completed, run by AstraZeneca. The registered enrollment target is 112 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00467649, a Phase 4 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 112 participants
- Enrollment target
Study Summary
This will be a randomized, open label, parallel group, multicenter study. There will be two phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients with type 2 diabetes who have either been on a prior regimen of insulin for less than 6 months and were taking less than 50 U total of insulin per day OR are candidates for the initiation of insulin therapy. The purpose of Phase 2 (Week 24 to Week 36) is to explore further intensification of diabetes regimens in patients failing to achieve HbA1c \<=6.5% at Week 24.
Primary Outcome
A severe hypoglycemia is defined as an event during which the patient required the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention.
Interventions
- DRUG pramlintide acetate (Symlin)
- DRUG rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])
- DRUG basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2007-05 |
| Est. Completion | 2008-04 |
| Phase | Phase 4 |
What the finished NCT00467649 record still lists
NCT00467649 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which pramlintide acetate (Symlin) is the first listed.
NCT00467649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00467649 about?
NCT00467649 is a clinical study titled "A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes". This will be a randomized, open label, parallel group, multicenter study. There will be two phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients with type 2 diabetes who...
What is the current status of trial NCT00467649?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 112 participants. The study started on 2007-05. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00467649?
The interventions under investigation include: pramlintide acetate (Symlin) (DRUG), rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]) (DRUG), basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir]) (DRUG).
Who is sponsoring clinical trial NCT00467649?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00467649's enrollment target sits among peer trials
112 724th of 2000 higher than 1,275 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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