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Completed

NCT Number: NCT00857558

A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes

A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes

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Key information

Conditions

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

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chubu Regin, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes patients with HbA1c above 7.0% and below 10%
  • Patients who are capable of giving informed consent
  • Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner

Exclusion criteria

  • Patients with type1 diabetes mellitus, patients with diabetes mellitus or impaired glucose tolerance (IGT) due to other specified mechanism or diseases, and patients with gestational diabetes mellitus
  • Patients with a medical history of diabetes coma
  • Patients with poorly-controlled hypertension
  • Patients with heart failure
  • Patients with a complication of active hepatitis or hepatic cirrhosis
  • Patients undergoing treatment of glomeruler diseases other than diabetic nephropathy
  • Patients with a history or complication of malignant tumor

Treatment and study plan

Saxagliptin

Drug

orally administration at 1 mg once a day for 12 weeks

Placebo

Drug

orally administration once a day for 12 weeks

Primary outcomes

  1. changes in HbA1C from baseline

    Time frame: 2w, 4w, 8w, 12w, 16w

Secondary outcomes

  1. values and changes in HbA1c form baseline

    Time frame: 2w, 4w, 8w, 12w, 16w

  2. values and changes in fasting blood glucose (FSB) from baseline

    Time frame: 2w, 4w, 8w, 12w, 16w

  3. adverse event

    Time frame: at any time

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 6, 2009
Registry last updated
Mar 9, 2017

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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