Completed PHASE2 INTERVENTIONAL 6-arm NCT00111800

A New Oral Treatment For Type II Diabetes Mellitus

A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Denagliptin, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus Followed by a 12-week Active Treatment Extension

Sponsor: GlaxoSmithKline

Conditions Diabetes Mellitus, Type 2

Interventions DEN 15 mg DEN 2.5 mg DEN 30 mg DEN 45 mg DEN 7.5 mg Placebo

Updated 8 times since 2017 Last updated: Mar 19, 2018 Started: Apr 28, 2005 Primary completion: Jul 1, 2006 Completion: Jul 21, 2006

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00111800, this PHASE2 trial focuses on Diabetes Mellitus, Type 2 and remains completed. Sponsored by GlaxoSmithKline, it has been updated 8 times since 2005, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of GW823093, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus followed by a 12-week Active Treatment Extension

Status Flow

Change History

8 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2

▶ Show 3 earlier versions

Mar 2018 — Jun 2018 [monthly]

Completed PHASE2
Feb 2017 — Mar 2018 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Apr 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

GlaxoSmithKline

Data source: GlaxoSmithKline

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albany, United States , Arlington, United States , Athens, Greece , Atlanta, United States , Bad Kreuznach, Germany , Bad Lauterberg im Harz, Germany , Bammental, Germany , Bay Roberts, Canada , Bellingham, United States , Brampton, Canada and 87 more locations