A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: GRC 8200	Phase 2

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment [ Time Frame: 4 and 8 weeks ]
2. Fasting plasma glucose and fasting serum insulin [ Time Frame: 12 weeks ]
3. Plasma glucose 2 hours post glucose challenge (OGTT) [ Time Frame: 12 weeks ]
4. HOMA-IR [ Time Frame: 12 weeks ]
5. HOMA-B [ Time Frame: 12 weeks ]
6. Change in serum lipids [ Time Frame: 12 weeks ]
7. Body weight [ Time Frame: 12 weeks ]
8. Waist circumference [ Time Frame: 12 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	30 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

India
Glenmark Investigational site
Mumbai, India

Sponsors and Collaborators

Glenmark Pharmaceuticals Europe Ltd. (R&D)

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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