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A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

Status

Unknown status

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

GRC 8200

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes mellitus, GRC 8200

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Glenmark Investigational site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

GRC 8200-25mg OD

GRC 8200-50mg OD

GRC 8200-50mg BD

GRC 8200-100mg OD

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment

Fasting plasma glucose and fasting serum insulin

Plasma glucose 2 hours post glucose challenge (OGTT)

HOMA-IR

HOMA-B

Change in serum lipids

Body weight

Waist circumference

Full Information

NCT ID

NCT00836940

First Posted

February 3, 2009

Last Updated

September 23, 2009

Sponsor

Glenmark Pharmaceuticals Europe Ltd. (R&D)

1. Study Identification

Unique Protocol Identification Number

NCT00836940

Brief Title

A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

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 Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Unknown status

Study Start Date

June 2008 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

October 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Glenmark Pharmaceuticals Europe Ltd. (R&D)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus, GRC 8200

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Experimental

Arm Description

GRC 8200-25mg OD

Arm Title

Arm Type

Experimental

Arm Description

GRC 8200-50mg OD

Arm Title

Arm Type

Experimental

Arm Description

GRC 8200-50mg BD

Arm Title

Arm Type

Experimental

Arm Description

GRC 8200-100mg OD

Intervention Type

Drug

Intervention Name(s)

GRC 8200

Intervention Description

Capsules, 25 to 100mg, once/ twice a day, 12 weeks

Primary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment

Time Frame

4 and 8 weeks

Title

Fasting plasma glucose and fasting serum insulin

Time Frame

12 weeks

Title

Plasma glucose 2 hours post glucose challenge (OGTT)

Time Frame

12 weeks

Title

HOMA-IR

Time Frame

12 weeks

Title

HOMA-B

Time Frame

12 weeks

Title

Change in serum lipids

Time Frame

12 weeks

Title

Body weight

Time Frame

12 weeks

Title

Waist circumference

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Glenmark Investigational site

City

Mumbai

Country

India

12. IPD Sharing Statement

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A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

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