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

A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-arms Parallel Group Comparative Study of OPC-262 in Patients With Type 2 Diabetes (Phase 2/3 Study)

The purpose of this clinical study is to evaluate the superiority of the efficacy of OPC-262 (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a double-blind fashion and to evaluate the safety of OPC-262 to placebo.

Study Overview

• Status: Completed
• Conditions: Diabetes Type 2
• Intervention / Treatment: Drug: OPC-262 2.5 mg; Drug: OPC-262 5 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 255
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Japan
  • Chubu Region, Japan
  • Chugoku Region, Japan
  • Kansai Region, Japan
  • Kanto Region, Japan
  • Kyushu Region, Japan
  • Shikoku Region, Japan
  • Tohoku Region, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Type 2 diabetes patients with HbA1C above 6.5% and below 10%
2. Patients who are capable of giving informed consent
3. Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)

Exclusion Criteria:

1. Patients with type 1 diabetes mellitus, patients with diabetes mellitus due to other specified drugs, mechanisms or diseases, and patients with gestational diabetes mellitus
2. Patients with a medical history of diabetic coma
3. Patients with poorly-controlled hypertension
4. Patients with heart failure
5. Patients with a complication of active hepatitis or hepatic cirrhosis
6. Patients undergoing treatment of glomerular diseases other than diabetic nephropathy
7. Patients with a history or complication of malignant tumor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OPC-262 2.5 mg; orally administered once daily for 24 weeks	Drug: OPC-262 2.5 mg; orally administered once daily for 24 weeks
Experimental: OPC-262 5 mg; orally administered once daily for 24 weeks	Drug: OPC-262 5 mg; orally administered once daily for 24 weeks
Placebo Comparator: Placebo; orally administered once daily for 24 weeks	Drug: Placebo; orally administered once daily for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in HbA1C from baseline	Week 24 (LOCF)

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in fasting blood glucose (FBG) from baseline	Week 24
Changes in 2 hour postprandial blood glucose (PPG) from baseline	Week 24
Changes in 3 hour PPG AUC from baseline	Week 24

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.
• Investigators: Study Chair: Kaatsuhisa Saito, OPCJ

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: October 16, 2009
• First Submitted That Met QC Criteria: October 16, 2009
• First Posted (Estimate): October 19, 2009

Study Record Updates

• Last Update Posted (Estimate): January 8, 2014
• Last Update Submitted That Met QC Criteria: January 6, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 262-09-001; JapicCTI-090904