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NCT00814294 · ClinicalTrials.gov registry record · Phase 2
Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus
A Phase 2 study, sponsored by Diasome Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 239
- Enrollment target
NCT00814294: Completed Phase 2 study, sponsored by Diasome Pharmaceuticals.
NCT00814294 is a Phase 2 study that has completed, run by Diasome Pharmaceuticals. The registered enrollment target is 239 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00814294, a Phase 2 study, has completed, sponsored by Diasome Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 239 participants
- Enrollment target
Study Summary
The primary objective of this trial is to compare the reduction in mean glycated hemoglobin levels (HbA1c) between 2 doses of oral HDV-I and placebo in type 2 diabetic patients on background metformin therapy at the end of 18 weeks of treatment. The secondary objectives are: * To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test, fasting plasma glucose (FPG), insulin, homeostasis model assessment of insulin resistance (HOMA-IR), homeostasis model assessment of β-cell function (HOMA-β), frequency of hypoglycemic events, body weight, and lipid levels; and * To evaluate the safety and tolerability of oral HDV-I.
Interventions
- DRUG placebo
- DRUG Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15)
- DRUG Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239 participants |
| Start Date | 2008-12 |
| Est. Completion | 2009-09 |
| Phase | Phase 2 |
What the finished NCT00814294 record still lists
NCT00814294 is an interventional study that assigns participants to a tested intervention. The registered 239 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00814294 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00814294 about?
NCT00814294 is a clinical study titled "Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus". The primary objective of this trial is to compare the reduction in mean glycated hemoglobin levels (HbA1c) between 2 doses of oral HDV-I and placebo in type 2 diabetic patients on background metformin therapy at the end of 18 weeks of treatment. The secondary objectives are: * To evaluate the effe...
What is the current status of trial NCT00814294?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 239 participants. The study started on 2008-12. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00814294?
The interventions under investigation include: placebo (DRUG), Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15) (DRUG), Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5) (DRUG).
Who is sponsoring clinical trial NCT00814294?
This trial is sponsored by Diasome Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00814294's enrollment target sits among peer trials
239 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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