A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00836940 |
Recruitment Status
: Unknown
Verified September 2009 by Glenmark Pharmaceuticals Europe Ltd. (R&D).
Recruitment status was: Active, not recruiting
First Posted
: February 4, 2009
Last Update Posted
: September 24, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus | Drug: GRC 8200 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 480 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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. |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | May 2009 |
Estimated Study Completion Date : | October 2009 |

Arm | Intervention/treatment |
---|---|
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
|
- Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period [ Time Frame: 12 weeks ]
- Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment [ Time Frame: 4 and 8 weeks ]
- Fasting plasma glucose and fasting serum insulin [ Time Frame: 12 weeks ]
- Plasma glucose 2 hours post glucose challenge (OGTT) [ Time Frame: 12 weeks ]
- HOMA-IR [ Time Frame: 12 weeks ]
- HOMA-B [ Time Frame: 12 weeks ]
- Change in serum lipids [ Time Frame: 12 weeks ]
- Body weight [ Time Frame: 12 weeks ]
- Waist circumference [ Time Frame: 12 weeks ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836940
India | |
Glenmark Investigational site | |
Mumbai, India |
Responsible Party: | Dr Manmath Patekar, Glenmark Pharmaceuticals ltd |
ClinicalTrials.gov Identifier: | NCT00836940 History of Changes |
Other Study ID Numbers: |
GRC 8200-301 |
First Posted: | February 4, 2009 Key Record Dates |
Last Update Posted: | September 24, 2009 |
Last Verified: | September 2009 |
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 |