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

March 7, 2017 updated by: Kyowa Kirin Co., Ltd.
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu regin, Japan
      • Chugoku region, Japan
      • Hokkaido region, Japan
      • Kanto region, Japan
      • Kinki region, Japan
      • Kyushu region, Japan
      • Shikoku region, Japan
      • Tohoku region, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 4
Drug: placebo
orally administration once a day for 12 weeks
EXPERIMENTAL: 1
OPC-262 1mg
Drug: saxagliptin
orally administration at 1 mg once a day for 12 weeks
Drug: saxagliptin
orally administration at 2.5 mg once a day for 12 weeks
Drug: saxagliptin
orally administration at 5 mg once a day for 12 weeks
EXPERIMENTAL: 2
OPC-262 2.5mg
Drug: saxagliptin
orally administration at 1 mg once a day for 12 weeks
Drug: saxagliptin
orally administration at 2.5 mg once a day for 12 weeks
Drug: saxagliptin
orally administration at 5 mg once a day for 12 weeks
EXPERIMENTAL: 3
OPC-262 5mg
Drug: saxagliptin
orally administration at 1 mg once a day for 12 weeks
Drug: saxagliptin
orally administration at 2.5 mg once a day for 12 weeks
Drug: saxagliptin
orally administration at 5 mg once a day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in HbA1C from baseline
Time Frame: 2w, 4w, 8w, 12w, 16w
2w, 4w, 8w, 12w, 16w

Secondary Outcome Measures

Outcome Measure
Time Frame
values and changes in HbA1c form baseline
Time Frame: 2w, 4w, 8w, 12w, 16w
2w, 4w, 8w, 12w, 16w
values and changes in fasting blood glucose (FSB) from baseline
Time Frame: 2w, 4w, 8w, 12w, 16w
2w, 4w, 8w, 12w, 16w
adverse event
Time Frame: at any time
at any time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

March 4, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (ESTIMATE)

March 6, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 262-08-001
  • JapicCTI-090697 (OTHER: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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