A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

Phase 2

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: GRC 8200

• Registration Number: NCT00836940
• Lead Sponsor: Glenmark Pharmaceuticals Europe Ltd. (R&D)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Primary Completion: 2009-05
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-23
• Last Update Posted: 2009-09-24
• Study Completion: 2009-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	GRC 8200	-
2	GRC 8200	GRC 8200-25mg OD
3	GRC 8200	GRC 8200-50mg OD
4	GRC 8200	GRC 8200-50mg BD
5	GRC 8200	GRC 8200-100mg OD

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment	4 and 8 weeks
Fasting plasma glucose and fasting serum insulin	12 weeks
Plasma glucose 2 hours post glucose challenge (OGTT)	12 weeks
HOMA-IR	12 weeks
HOMA-B	12 weeks
Change in serum lipids	12 weeks
Body weight	12 weeks
Waist circumference	12 weeks

Trial Locations

Locations (1)

Glenmark Investigational site; 🇮🇳 Mumbai, India