A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GRC 8200

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No