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Completed

NCT Number: NCT00952445

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

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.

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Key information

Conditions

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

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Whittier Diabetes Institute, La Jolla, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T0903131 Besylate

Drug

Once daily, oral

Other names: INT131 Besylate

Placebo

Drug

Once daily, oral

Sponsors and collaborators

Lead sponsor

InteKrin Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Aug 6, 2009
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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