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Completed

NCT Number: NCT01111955

Safety Study of BMS-823778 in Subjects With Type 2 Diabetes

The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on fasting plasma glucose (FPG).

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Blacktown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes mellitus
  • Drug naive or on stable metformin therapy
  • HbA1c 7-10%
  • FPG ≤ 240mg/dL

Exclusion criteria

  • History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study
  • Congestive heart failure
  • Active liver disease
  • Impaired renal function
  • Hepatitis C, B and HIV

This list is not inclusive; additional information is provided in the protocol

Treatment and study plan

BMS-823778

Drug

Capsules, Oral, 2 mg, once daily, 28 days

Placebo

Drug

Capsules, Oral, 0 mg, once daily, 28 days

metformin

Drug

Capsules, Oral, ≥ 1500 mg, once daily, 28 days

Primary outcomes

  1. Lowering of fasting plasma glucose (FPG) throughout the study to see if there is a decrease from baseline

    Time frame: Within 28 days following dosing

Secondary outcomes

  1. Pharmacokinetics (measuring trough concentrations)

    Time frame: On days 7, 14 and 28

  2. Pharmacodynamics (measuring daily glucose, glucose AUC, HbA1c, lipid profiles, HPA markers, free testosterone, and SHBG)

    Time frame: Within 28 days following dosing

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Double-blind, Placebo-Controlled, Parallel-group, Randomized, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of BMS-823778 in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Either Diet and Exercise Alone or on a Background of Metformin

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 28, 2010
Registry last updated
Oct 12, 2015

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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