Clinical trial NCT00387972: Study Of Denagliptin In Subjects With Type 2 Diabetes Mellitus (T2DM)
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus (T2DM)
glycosylated hemoglobin (HbA1c)
denagliptin
diabetes treatment
glycemic control
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in blood glucose regulation after 26 weeks of treatment
Secondary outcomes:
measure: Change from baseline in glycemic parameters, insulin, body weight and waist circumference, and safety measures
Other outcomes:
Locations:
city: Tallassee
country: United States
facility: GSK Clinical Trials Call Center
state: Alabama
city: Phoenix
country: United States
facility: GSK Clinical Trials Call Center
state: Arizona
city: Tucson
country: United States
facility: GSK Clinical Trials Call Center
state: Arizona
city: Beverly Hills
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Carmichael
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Concord
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Torrance
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Victorville
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Wilmington
country: United States
facility: GSK Clinical Trials Call Center
state: Delaware
city: Boynton Beach
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Clearwater
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Coral Gables
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Hialeah
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Hollywood
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Melbourne
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Miami
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Opalocka
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Plantation
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Tampa
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Calhoun
country: United States
facility: GSK Clinical Trials Call Center
state: Georgia
city: Roswell
country: United States
facility: GSK Clinical Trials Call Center
state: Georgia
city: Hayden Lake
country: United States
facility: GSK Clinical Trials Call Center
state: Idaho
city: Chicago
country: United States
facility: GSK Clinical Trials Call Center
state: Illinois
city: Chicago
country: United States
facility: GSK Clinical Trials Call Center
state: Illinois
city: Lake Zurich
country: United States
facility: GSK Clinical Trials Call Center
state: Illinois
city: Watseka
country: United States
facility: GSK Clinical Trials Call Center
state: Illinois
city: Baton Rouge
country: United States
facility: GSK Clinical Trials Call Center
state: Louisiana
city: Marrero
country: United States
facility: GSK Clinical Trials Call Center
state: Louisiana
city: Oxon Hill
country: United States
facility: GSK Clinical Trials Call Center
state: Maryland
city: Detroit
country: United States
facility: GSK Clinical Trials Call Center
state: Michigan
city: Florissant
country: United States
facility: GSK Clinical Trials Call Center
state: Missouri
city: St. Louis
country: United States
facility: GSK Clinical Trials Call Center
state: Missouri
city: St. Peters
country: United States
facility: GSK Clinical Trials Call Center
state: Missouri
city: Las Vegas
country: United States
facility: GSK Clinical Trials Call Center
state: Nevada
city: Williamsville
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: Charlotte
country: United States
facility: GSK Clinical Trials Call Center
state: North Carolina
city: Morehead City
country: United States
facility: GSK Clinical Trials Call Center
state: North Carolina
city: Fargo
country: United States
facility: GSK Clinical Trials Call Center
state: North Dakota
city: Cincinnati
country: United States
facility: GSK Clinical Trials Call Center
state: Ohio
city: Columbus
country: United States
facility: GSK Clinical Trials Call Center
state: Ohio
city: Guthrie
country: United States
facility: GSK Clinical Trials Call Center
state: Oklahoma
city: Norman
country: United States
facility: GSK Clinical Trials Call Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: GSK Clinical Trials Call Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: GSK Clinical Trials Call Center
state: Oklahoma
city: Yukon
country: United States
facility: GSK Clinical Trials Call Center
state: Oklahoma
city: Eugene
country: United States
facility: GSK Clinical Trials Call Center
state: Oregon
city: Medford
country: United States
facility: GSK Clinical Trials Call Center
state: Oregon
city: Beaver Falls
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Fleetwood
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Warminster
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Anderson
country: United States
facility: GSK Clinical Trials Call Center
state: South Carolina
city: Chattanooga
country: United States
facility: GSK Clinical Trials Call Center
state: Tennessee
city: Johnson City
country: United States
facility: GSK Clinical Trials Call Center
state: Tennessee
city: Cleburne
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: San Antonio
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: Seguin
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: Weber City
country: United States
facility: GSK Clinical Trials Call Center
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trial, DM, FRCP
role: STUDY_DIRECTOR
References: