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

This study has suspended participant recruitment.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00387972

First received: October 12, 2006

Last updated: November 8, 2006

Last verified: November 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

October 12, 2006

Last Updated Date

November 8, 2006

Start Date ^ICMJE

May 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Change from baseline in blood glucose regulation after 26 weeks of treatment

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00387972 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in glycemic parameters, insulin, body weight and waist circumference, and safety measures

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: denagliptin (GW823093)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Enrollment ^ICMJE

450

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00387972

Other Study ID Numbers ^ICMJE

DPB107246

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trial, DM, FRCP

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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