A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Glenmark Pharmaceuticals Europe Ltd. (R&D).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Glenmark Pharmaceuticals Europe Ltd. (R&D)
Information provided by:
Glenmark Pharmaceuticals Europe Ltd. (R&D)
ClinicalTrials.gov Identifier:
NCT00836940
First received: February 3, 2009
Last updated: September 23, 2009
Last verified: September 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: GRC 8200 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Glenmark Pharmaceuticals Europe Ltd. (R&D):
Primary Outcome Measures:
- Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
- Fasting plasma glucose and fasting serum insulin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Plasma glucose 2 hours post glucose challenge (OGTT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- HOMA-IR [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- HOMA-B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in serum lipids [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Waist circumference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 480 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | October 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: GRC 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
|
|
Experimental: 2
GRC 8200-25mg OD
|
Drug: GRC 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
|
|
Experimental: 3
GRC 8200-50mg OD
|
Drug: GRC 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
|
|
Experimental: 4
GRC 8200-50mg BD
|
Drug: GRC 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
|
|
Experimental: 5
GRC 8200-100mg OD
|
Drug: GRC 8200
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
|
Eligibility| Ages Eligible for Study: | 30 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836940
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836940
Locations
| India | |
| Glenmark Investigational site | |
| Mumbai, India | |
Sponsors and Collaborators
Glenmark Pharmaceuticals Europe Ltd. (R&D)
More Information
| Responsible Party: | Dr Manmath Patekar, Glenmark Pharmaceuticals ltd |
| ClinicalTrials.gov Identifier: | NCT00836940 History of Changes |
| Other Study ID Numbers: | GRC 8200-301 |
| Study First Received: | February 3, 2009 |
| Last Updated: | September 23, 2009 |
| Health Authority: | India: Drugs Controller General of India India: Institutional Review Board |
Keywords provided by Glenmark Pharmaceuticals Europe Ltd. (R&D):
|
Type 2 diabetes mellitus GRC 8200 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on September 27, 2016