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NCT00976261 · ClinicalTrials.gov registry record · Phase 1

A 2-Part Trial in Subjects With Type 2 Diabetes and in Healthy Subjects to Evaluate GSK1614235, a New Glucose Lowering Drug to Treat Type 2 Diabetes

A Phase 1 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 1
Development phase
72
Enrollment target

NCT00976261: Completed Phase 1 study, sponsored by GlaxoSmithKline.

NCT00976261 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00976261, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 1
Development phase
72 participants
Enrollment target

Study Summary

The purpose of Part A of this study is to test whether repeated doses of the study drug (GSK1614235) are safe and well tolerated (i.e. do not produce unacceptable side effects) and whether we can obtain some preliminary information as to whether it works in lowering blood glucose levels. We will do this by comparing the effect of the study drug with placebo (no drug present) and against a drug (sitagliptin) known to control blood glucose in the treatment of diabetes. The purpose of Part B of this study is to determine the how the timing of dosing, relative to meals, affects the response to study drug.

Interventions

  • OTHER Placebo
  • DRUG Sitagliptin
  • DRUG GSK1614235

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2009-10-17
Est. Completion 2010-09-05
Phase Phase 1
GlaxoSmithKline

1,345 total trials

What the finished NCT00976261 record still lists

NCT00976261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00976261 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00976261 about?

NCT00976261 is a clinical study titled "A 2-Part Trial in Subjects With Type 2 Diabetes and in Healthy Subjects to Evaluate GSK1614235, a New Glucose Lowering Drug to Treat Type 2 Diabetes". The purpose of Part A of this study is to test whether repeated doses of the study drug (GSK1614235) are safe and well tolerated (i.e. do not produce unacceptable side effects) and whether we can obtain some preliminary information as to whether it works in lowering blood glucose levels. We will do ...

What is the current status of trial NCT00976261?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2009-10-17. Estimated completion is 2010-09-05.

What interventions are being tested in trial NCT00976261?

The interventions under investigation include: Placebo (OTHER), Sitagliptin (DRUG), GSK1614235 (DRUG).

Who is sponsoring clinical trial NCT00976261?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00976261's enrollment target sits among peer trials

72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT00976261, the US trial registry maintained by the National Library of Medicine. NCT00976261 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.