NCT00369148

Brief Summary

Combination therapy of glinides with premixed insulin provides better glycemic control than premixed insulin alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

6 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

July 1, 2004

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2006

Completed
Last Updated

August 26, 2009

Status Verified

August 1, 2009

First QC Date

August 28, 2006

Last Update Submit

August 25, 2009

Conditions

Type 2 Diabets Mellitus

Keywords

glinidespremixed insulincombination therapyglycemic control

Outcome Measures

Primary Outcomes (1)

  • glycohemoglobin

Secondary Outcomes (4)

  • anhydroglucitol

  • lipid profile

  • body weight

  • blood pressure

Interventions

nateglinide(drug) mitiglinide(drug)DRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of type 2 diabetes
  • Who undergoes twice daily injection of premixed insulin
  • Whose HbA1c is more than 6.5% and less than 8.0%

You may not qualify if:

  • Whose change of HbA1c is more than 1.0% during 12 weeks observational period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Nippon Kokan Hospital

Kawasaki, Kanagawa, 210-0852, Japan

Location

Hamamatsu Red Cross Hospital

Hamamatsu, Shizuoka, 430-0907, Japan

Location

Saiseikai Central Hospital

Minato-ku, Tokyo, 108-0073, Japan

Location

Kitasato Institute Hospital

Minato-ku, Tokyo, 108-8642, Japan

Location

Keio University Hospital

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Tokyo Metropolitan Ohtsuka Hospital

Toshima-ku, Tokyo, 170-8476, Japan

Location

Study Officials

  • Akira Shimada, MD, PhD

    Keio University

    STUDY CHAIR

  • Yoshihito Atsumi, MD

    Saiseikai Central Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2006

First Posted

August 29, 2006

Study Start

July 1, 2004

Study Completion

March 1, 2006

Last Updated

August 26, 2009

Record last verified: 2009-08

Locations

JP(6)