Trial | NCT00952445  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    t131 ...

  • Study Participants

    70
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.
Study Started
Dec 31
2003
Study Completion
Jun 30
2004
Last Update
Oct 19
2022

Drug T0903131 Besylate

Once daily, oral

  • Other names: INT131 Besylate

Drug Placebo

Once daily, oral

T0903131 Besylate Experimental

1.0 mg

T0903131 Besylate (higher dose) Experimental

10.0 mg

Placebo Placebo Comparator

Once daily, oral

Criteria 

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
No Results Posted