NCT00857558

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

March 4, 2009

Last Update Submit

March 7, 2017

Conditions

Diabetes, Type 2

Outcome Measures

Primary Outcomes (1)

  • changes in HbA1C from baseline

    2w, 4w, 8w, 12w, 16w

Secondary Outcomes (3)

  • values and changes in HbA1c form baseline

    2w, 4w, 8w, 12w, 16w

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

    2w, 4w, 8w, 12w, 16w

  • adverse event

    at any time

Study Arms (4)

1

EXPERIMENTAL

OPC-262 1mg

Drug: saxagliptin

2

EXPERIMENTAL

OPC-262 2.5mg

Drug: saxagliptin

3

EXPERIMENTAL

OPC-262 5mg

Drug: saxagliptin

4

PLACEBO COMPARATOR
Drug: placebo

Interventions

saxagliptinDRUG

orally administration at 1 mg once a day for 12 weeks

1
placeboDRUG

orally administration once a day for 12 weeks

4

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chubu Regin, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Katsuhisa Saito

    OPC-J

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 6, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2010

Study Completion

May 1, 2010

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

JP(8)