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A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • Fasting plasma glucose and fasting serum insulin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Plasma glucose 2 hours post glucose challenge (OGTT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • HOMA-IR [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • HOMA-B [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in serum lipids [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: India: Drugs Controller General of India
India: Institutional Review Board

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 May 16, 2013