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A Safety and Efficacy Study of T0903131 (INT131) Besylate to Treat Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00952445
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : August 6, 2009
Information provided by:
InteKrin Therapeutics, Inc.

Brief Summary:
The purpose of the study is to determine if repeated daily doses of T0903131 (INT131) Besylate over 4 weeks can lower fasting blood glucose in patients with Type 2 Diabetes Mellitus.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type II Drug: T0903131 Besylate Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, 4-week Study to Evaluate the Safety and Efficacy of T0903131 Besylate in Subjects With Type 2 Diabetes Mellitus
Study Start Date : December 2003
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: T0903131 Besylate
1.0 mg
Drug: T0903131 Besylate
Once daily, oral
Other Name: INT131 Besylate

Experimental: T0903131 Besylate
10.0 mg
Drug: T0903131 Besylate
Once daily, oral
Other Name: INT131 Besylate

Placebo Comparator: Placebo
Once daily, oral
Drug: Placebo
Once daily, oral

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical Diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to enrollment
  • Fasting Plasma Glucose between 126 and 240 mg/dL
  • Hemoglobin-A1c (HbA1c) between 6.8% and 10.0%
  • Fasting C-peptide > 0.8 ng/mL

Exclusion Criteria:

  • Treatment with any pharmacotherapy for Type 2 Diabetes Mellitus within previous 6 weeks prior to screening
  • Prior treatment with Thiazolidinedione, including Troglitazone, Rosiglitazone, pioglitazone
  • BMI > 42 kg/m2
  • Presence of any diabetic complications requiring chronic therapy
  • Presence or history of any form of hepatic disease
  • Serum creatinine > 1.8 mg/dL
  • History of cardiac arrhythmias or abnormal cardiac electrophysiology
  • Any reason that, in the Investigator's judgment, would have interfered with the ability of the subject to comply with the requirements of the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00952445

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Sponsors and Collaborators
InteKrin Therapeutics, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00952445    
Other Study ID Numbers: T-131-004
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: August 6, 2009
Last Verified: August 2009
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases