A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2009 by Glenmark Pharmaceuticals Europe Ltd. (R&D).
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by:

Glenmark Pharmaceuticals Europe Ltd. (R&D)

ClinicalTrials.gov Identifier:

NCT00836940

First received: February 3, 2009

Last updated: September 23, 2009

Last verified: September 2009

History of Changes

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: GRC 8200	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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.

Further study details as provided by Glenmark Pharmaceuticals Europe Ltd. (R&D):

Primary Outcome Measures:

Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

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


Estimated Enrollment:	480
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	30 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836940

Locations


India
Glenmark Investigational site
Mumbai, India

Sponsors and Collaborators

Glenmark Pharmaceuticals Europe Ltd. (R&D)

More Information


Responsible Party:	Dr Manmath Patekar, Glenmark Pharmaceuticals ltd
ClinicalTrials.gov Identifier:	NCT00836940 History of Changes
Other Study ID Numbers:	GRC 8200-301
Study First Received:	February 3, 2009
Last Updated:	September 23, 2009

Keywords provided by Glenmark Pharmaceuticals Europe Ltd. (R&D):


Type 2 diabetes mellitus GRC 8200

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases

ClinicalTrials.gov processed this record on July 19, 2017

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