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OpenTrials
Completed

NCT Number: NCT00212641

A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus

The objectives of this study are to characterize the pharmacodynamic profile, safety and tolerability of ONO-5129 in patients with Type 2 Diabetes mellitus

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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

Apex Clinical Trials, Inc., Birmingham, Alabama, United States

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
  • FBG level > 140 mg/dL and < 270 mg/dL
  • Fasting TG level < 500 mg/dL
  • BMI of 22 to 40 kg/m2, inclusive
  • Other Inclusion criteria as specified in the study protocol

Exclusion criteria

  • Previous participation in an ONO-5129 protocol
  • Previous treatment with TZD agents or other current antidiabetics
  • History of myocardial infarction, coronary artery surgery, atrial/ventricular tachycardia, or atrial/ventricular fibrillation in the past six months
  • Presence of functional limitations due to cardiovascular disease in accordance with the New York Heart Association Classification System - Class III (moderate) or IV (severe)
  • Other exclusion criteria as specified in the study protocol

Treatment and study plan

ONO-5129

Drug

Primary outcomes

  1. Fasting Blood Glucose at 8 weeks

Secondary outcomes

  1. Pharmacodynamic parameters at all time points

Sponsors and collaborators

Lead sponsor

Ono Pharma USA Inc

Industry

Registry information

Official study title

Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus

Important dates

Study start
2005
Primary completion
2007
First posted
Sep 21, 2005
Registry last updated
Oct 11, 2012

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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