Pilot Study of ONO-5129 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of ONO-5129 in patients with type 2 diabetes mellitus.

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Key information

Conditions

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

Age range

45 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kanto Region, Kanto, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Fasting Blood Glucose 126-250mg/dL
HbA1c 6.5-11%

Exclusion criteria

Previous treatment with antidiabetic agents equal to or less than 2-3 months prior to randomization
History of myocardial infarction, coronary artery surgery
Other eligibility criteria as specified in the study protocol

Treatment and study plan

ONO-5129

Drug

Primary outcomes

Fasting Blood Glucose at week 8

Secondary outcomes

Other glycemic control parameters (e.g., HbA1c, glycoalbumin)

Sponsors and collaborators

Lead sponsor

Ono Pharma USA Inc

Industry

Registry information

Official study title

Phase II Study of ONO-5129 in Patients With Type 2 Diabetes Mellitus

Important dates

Study start: 2006
First posted: Jun 12, 2006
Registry last updated: Jun 13, 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.

Published trials that share one or more normalized conditions with this study.

Completed