NCT00461617

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Mitiglinide compared to Nateglinide for the treatment of type 2 diabetes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
291

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_3 diabetes

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

August 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

October 21, 2008

Status Verified

April 1, 2007

Enrollment Period

11 months

First QC Date

April 17, 2007

Last Update Submit

October 20, 2008

Conditions

Diabetes

Keywords

diabetesrapid and short acting insulin secretagogueα-glucosidase inhibitorHbA1Cinsulin

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1C (HbA1C)

    -2, 0, 4, 8, 10, 12, 16, 20 week

Secondary Outcomes (3)

  • Fasting plasma glucose level (FPG)

    0, 4, 8, 12, 16, 20 week

  • Two-hour postprandial glucose level (PPG2)

    0, 12, 20 week

  • One-hour postprandial glucose level (PPG1)

    0, 12, 20 week

Study Arms (1)

2

ACTIVE COMPARATOR

Nateglinide 120 mg TID

Drug: Mitiglinide

Interventions

MitiglinideDRUG

10mg tablet, 10mg TID

Also known as: Glufast
2

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes patients with inadequate control of blood glucose with diet and/or exercise therapy

You may not qualify if:

  • Type 1 diabetes patients
  • Patients who require treatment with insulin
  • Patients with severe diabetic complications (neuropathy, retinopathy or nephropathy)
  • Patients with severe ketosis, diabetic coma or precoma
  • Patients complicated with severe hepatic diseases
  • Patients complicated with severe renal diseases
  • Patients complicated with severe hypertension
  • Patients complicated with severe cardiac disease
  • Pregnant women or women possible to be pregnant, nursing women, or women who want to become pregnant during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusFastingInsulin Resistance

Interventions

mitiglinide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFeeding BehaviorBehaviorHyperinsulinism

Study Officials

  • Xin Gao, Professor

    Endocrinology Dept. of Fudan University Zhongshan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 17, 2007

First Posted

April 18, 2007

Study Start

August 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

October 21, 2008

Record last verified: 2007-04