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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 is a Phase 4 study that has completed, run by AstraZeneca. The registered enrollment target is 112 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00467649
The ClinicalTrials.gov registry entry for NCT00467649 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which pramlintide acetate (Symlin) is the first listed.
NCT00467649 reports 0 study locations.
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.
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