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CompletedNCT00997282Updated Jan 8, 2014

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

A Phase 2/3 interventional study of OPC-262 2.5 mg and OPC-262 5 mg in Diabetes Type 2, sponsored by Kyowa Kirin Co., Ltd.. Completed at 7 sites in Japan. Open to participants aged 20 Years to 74 Years. Per ClinicalTrials.gov, last updated 2014-01-08.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
255
Allocation
Randomized
Ages
20 Years to 74 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Diabetes Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 255 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Kyowa Kirin Co., Ltd. is the lead sponsor of 155 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
255 participants (estimated)

Study arms

  • Experimental
    OPC-262 2.5 mg

    orally administered once daily for 24 weeks

    Drug: OPC-262 2.5 mg

  • Experimental
    OPC-262 5 mg

    orally administered once daily for 24 weeks

    Drug: OPC-262 5 mg

  • Placebo comparator
    Placebo

    orally administered once daily for 24 weeks

    Drug: Placebo

Interventions

  • DrugOPC-262 2.5 mg

    orally administered once daily for 24 weeks

  • DrugOPC-262 5 mg

    orally administered once daily for 24 weeks

  • DrugPlacebo

    orally administered once daily for 24 weeks

06

What researchers measure

Primary outcomes

  1. Changes in HbA1C from baseline

    Time frame: Week 24 (LOCF)

Secondary outcomes

  1. Changes in fasting blood glucose (FBG) from baseline

    Time frame: Week 24

  2. Changes in 2 hour postprandial blood glucose (PPG) from baseline

    Time frame: Week 24

  3. Changes in 3 hour PPG AUC from baseline

    Time frame: Week 24

07

Study locations

7 sites
  • Chubu Region, Japan
  • Chugoku Region, Japan
  • Kansai Region, Japan
  • Kanto Region, Japan
  • Kyushu Region, Japan
  • Shikoku Region, Japan
  • Tohoku Region, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00997282
Lead sponsor
Kyowa Kirin Co., Ltd.
First posted
Oct 19, 2009
Start date
Sep 2009
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Jan 8, 2014

Study contacts

Kaatsuhisa Saito
study chair · OPCJ

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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