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NCT00894322 · ClinicalTrials.gov registry record · Phase 1
A Study to Examine the Pharmacokinetics, Tolerability, Safety and Efficacy of Exenatide Once Weekly Suspension
A Phase 1 study of Type 2 Diabetes Mellitus, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT00894322: Completed Phase 1 study of Type 2 Diabetes Mellitus, sponsored by AstraZeneca.
NCT00894322 is a Phase 1 study of Type 2 Diabetes Mellitus that has completed, run by AstraZeneca. The registered enrollment target is 65 participants, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00894322, a Phase 1 study of Type 2 Diabetes Mellitus, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to evaluate the pharmacokinetics, tolerability, and safety of exenatide once weekly suspension in both healthy subjects and in subjects with type 2 diabetes. The study will also evaluate efficacy in the type 2 diabetes patients. Development of this exenatide once weekly presentation would eliminate the need to reconstitute the product prior to use.
Primary Outcome
Cohort 1: Blood samples for the assessment of plasma exenatide were collected at time = -15, 60, 90, 120, 180, 240, 360, and 480 minutes relative to study medication injection at time = 0 on Day 1 and the mean is presented below. At all visits following the single injection, a single blood sample was collected for assessment of exenatide concentrations. AUC was measured in picograms \* hours per milliliter (pg\*hr/mL). Exenatide was measured using a validated enzyme-linked immunosorbent assay (E
Conditions Studied
Interventions
- OTHER Placebo
- DRUG exenatide once weekly
Study Locations (1)
Nebraska
- Research Site - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2009-04 |
| Est. Completion | 2009-08 |
| Phase | Phase 1 |
What the finished NCT00894322 record still lists
NCT00894322 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00894322 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT00894322 about?
NCT00894322 is a clinical study titled "A Study to Examine the Pharmacokinetics, Tolerability, Safety and Efficacy of Exenatide Once Weekly Suspension". This study is designed to evaluate the pharmacokinetics, tolerability, and safety of exenatide once weekly suspension in both healthy subjects and in subjects with type 2 diabetes. The study will also evaluate efficacy in the type 2 diabetes patients. Development of this exenatide once weekly presen...
What is the current status of trial NCT00894322?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2009-04. Estimated completion is 2009-08.
What conditions does trial NCT00894322 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.
What interventions are being tested in trial NCT00894322?
The interventions under investigation include: Placebo (OTHER), exenatide once weekly (DRUG).
Who is sponsoring clinical trial NCT00894322?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00894322 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes Mellitus
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 NCT00894322's enrollment target sits among peer trials
65 71st of 130 higher than 60 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus 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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