Study Of Denagliptin In Subjects With Type 2 Diabetes Mellitus (T2DM)

A Multi-center, Double-blind, Parallel-group, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Denagliptin in Subjects With Type 2 Diabetes Mellitus

Status

Withdrawn

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00387972

Enrollment

Registered

2006-10-13

Start date

2006-05-31

Completion date

2007-10-31

Last updated

2015-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus (T2DM), glycosylated hemoglobin (HbA1c), denagliptin, diabetes treatment, glycemic control

Brief summary

GW823093 is a selective DPP-IV Inhibitor and is being investigated as a once a day oral therapy. The purpose of the Study is to evaluate the effectiveness, safety, and tolerability of 2 doses of GW823093, compared to placebo, taken once daily in patients with Type 2 diabetes mellitus.

Interventions

DRUGdenagliptin (GW823093)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Type 2 diabetes mellitus treated with diet and exercise or oral anti-diabetic treatment * Body mass index between 20 and 40 * Females of childbearing potential must use adequate birth control.

Exclusion criteria

* Subjects with previous use of insulin * Type 1 diabetes * Uncontrolled thyroid disease * History of drug or alcohol abuse in the past year * Any other clinically significant disease.

Design outcomes

Primary

Measure	Time frame
Change from baseline in blood glucose regulation after 26 weeks of treatment	—

Secondary

Measure	Time frame
Change from baseline in glycemic parameters, insulin, body weight and waist circumference, and safety measures	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026