A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

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.

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: GRC 8200

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Mumbai, India
    • Glenmark Investigational site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Body weight	12 weeks
HOMA-IR	12 weeks
Waist circumference	12 weeks
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-B	12 weeks
Change in serum lipids	12 weeks

Collaborators and Investigators

• Sponsor: Glenmark Pharmaceuticals Europe Ltd. (R&D)

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Anticipated): October 1, 2009

Study Registration Dates

• First Submitted: February 3, 2009
• First Submitted That Met QC Criteria: February 3, 2009
• First Posted (Estimate): February 4, 2009

Study Record Updates

• Last Update Posted (Estimate): September 24, 2009
• Last Update Submitted That Met QC Criteria: September 23, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Type 2 diabetes mellitus; GRC 8200
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: GRC 8200-301