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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00836940

Enrollment

480

Registered

2009-02-04

Start date

2008-06-30

Completion date

2009-10-31

Last updated

2009-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus, GRC 8200

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.

Interventions

DRUGGRC 8200

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026