A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
GRC 8200
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes mellitus, GRC 8200
Eligibility Criteria
Inclusion Criteria:
- Male or female patients ≥30 years of age
- At screening, females of non-childbearing potential or females of childbearing potential with adequate contraception
- Has an established clinical diagnosis of type 2 diabetes mellitus for at least 3 months prior to the screening period
- Is being treated for diabetes either with diet and exercise alone, or on monotherapy with any of the antidiabetic drugs
- Has an HbA1c value at screening between 6.5% and 10%
Exclusion Criteria:
- Has type 1 diabetes
- Is a female who is lactating or is pregnant
- Has a history of acute metabolic diabetic complications
- Has clinically significant disease other than type 2 diabetes mellitus
Sites / Locations
- Glenmark Investigational site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
Arm Description
GRC 8200-25mg OD
GRC 8200-50mg OD
GRC 8200-50mg BD
GRC 8200-100mg OD
Outcomes
Primary Outcome Measures
Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period
Secondary Outcome Measures
Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment
Fasting plasma glucose and fasting serum insulin
Plasma glucose 2 hours post glucose challenge (OGTT)
HOMA-IR
HOMA-B
Change in serum lipids
Body weight
Waist circumference
Full Information
NCT ID
NCT00836940
First Posted
February 3, 2009
Last Updated
September 23, 2009
Sponsor
Glenmark Pharmaceuticals Europe Ltd. (R&D)
1. Study Identification
Unique Protocol Identification Number
NCT00836940
Brief Title
A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus
Official Title
A 12-week Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate Safety, Tolerability, and Efficacy of GRC 8200, a New Oral DPP -IV Inhibitor, in Patients With Type 2 Diabetes Mellitus.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
October 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Glenmark Pharmaceuticals Europe Ltd. (R&D)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study is aimed at evaluating efficacy and safety of GRC 8200 in type 2 diabetes mellitus patients.
The study involves six weeks of wash out period and two weeks run in period for patients currently on mono-therapy and a two week run in period only for drug naïve patients.
This is a placebo controlled study. One of the five treatment arms is placebo. The duration of treatment is 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 diabetes mellitus, GRC 8200
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Arm Description
GRC 8200-25mg OD
Arm Title
3
Arm Type
Experimental
Arm Description
GRC 8200-50mg OD
Arm Title
4
Arm Type
Experimental
Arm Description
GRC 8200-50mg BD
Arm Title
5
Arm Type
Experimental
Arm Description
GRC 8200-100mg OD
Intervention Type
Drug
Intervention Name(s)
GRC 8200
Intervention Description
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment
Time Frame
4 and 8 weeks
Title
Fasting plasma glucose and fasting serum insulin
Time Frame
12 weeks
Title
Plasma glucose 2 hours post glucose challenge (OGTT)
Time Frame
12 weeks
Title
HOMA-IR
Time Frame
12 weeks
Title
HOMA-B
Time Frame
12 weeks
Title
Change in serum lipids
Time Frame
12 weeks
Title
Body weight
Time Frame
12 weeks
Title
Waist circumference
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients ≥30 years of age
At screening, females of non-childbearing potential or females of childbearing potential with adequate contraception
Has an established clinical diagnosis of type 2 diabetes mellitus for at least 3 months prior to the screening period
Is being treated for diabetes either with diet and exercise alone, or on monotherapy with any of the antidiabetic drugs
Has an HbA1c value at screening between 6.5% and 10%
Exclusion Criteria:
Has type 1 diabetes
Is a female who is lactating or is pregnant
Has a history of acute metabolic diabetic complications
Has clinically significant disease other than type 2 diabetes mellitus
Facility Information:
Facility Name
Glenmark Investigational site
City
Mumbai
Country
India
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus
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