GW823093C For The Treatment Of Type 2 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW823093C A
GW823093C B
GW823093C C
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring GW823093C, diabetes, type 2 diabetes mellitus, DPP-IV inhibitor
Eligibility Criteria
Inclusion criteria: Type 2 diabetes mellitus. Managed by diet therapy or receiving treatment with oral anti-diabetic monotherapy (excluding TZD (Thiazolidinediones)) Exclusion criteria: Patients who have metabolic disease judged by investigator as a clinically significance Serious cardiovascular disease or serious hepatic disease
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Placebo Comparator
Placebo Comparator
Arm Label
GW823093C A
GW823093C B
GW823093C C
Arm Description
A=45 mg
B=30 mg
C=15 mg
Outcomes
Primary Outcome Measures
Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group
Secondary Outcome Measures
Long term safety variables
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00370942
Brief Title
GW823093C For The Treatment Of Type 2 Diabetes Mellitus
Official Title
GW823093 Japan Phase IIa Mono
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Safety issue
Study Start Date
April 1, 2006 (undefined)
Primary Completion Date
November 1, 2006 (Actual)
Study Completion Date
November 25, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study was designed to find dose response and as extension in treatment of GW823093C.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
GW823093C, diabetes, type 2 diabetes mellitus, DPP-IV inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GW823093C A
Arm Type
Placebo Comparator
Arm Description
A=45 mg
Arm Title
GW823093C B
Arm Type
Placebo Comparator
Arm Description
B=30 mg
Arm Title
GW823093C C
Arm Type
Placebo Comparator
Arm Description
C=15 mg
Intervention Type
Drug
Intervention Name(s)
GW823093C A
Intervention Description
A=45 mg
Intervention Type
Drug
Intervention Name(s)
GW823093C B
Intervention Description
B=30 mg
Intervention Type
Drug
Intervention Name(s)
GW823093C C
Intervention Description
C=25 mg
Primary Outcome Measure Information:
Title
Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Long term safety variables
Time Frame
64 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Type 2 diabetes mellitus.
Managed by diet therapy or receiving treatment with oral anti-diabetic monotherapy (excluding TZD (Thiazolidinediones))
Exclusion criteria:
Patients who have metabolic disease judged by investigator as a clinically significance
Serious cardiovascular disease or serious hepatic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
051-0005
Country
Japan
Facility Name
GSK Investigational Site
City
Miyagi
ZIP/Postal Code
985-0852
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
130-0004
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
160-0017
Country
Japan
Facility Name
GSK Investigational Site
12. IPD Sharing Statement
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GW823093C For The Treatment Of Type 2 Diabetes Mellitus
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