NCT00663884

Brief Summary

We will evaluate the efficacy and safety of combination therapy of 10 mg mitiglinide or 0.2mg voglibose with insulin glargine for 16 weeks after single administration of insulin glargine for 4 weeks in type 2 diabetic patients whose glycemic control were not enough despite administration of oral antidiabetic drug or insulin glargine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
167

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

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

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 30, 2012

Status Verified

March 1, 2012

Enrollment Period

1.4 years

First QC Date

April 18, 2008

Last Update Submit

March 28, 2012

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes mellitus, Type 2mitiglinide

Outcome Measures

Primary Outcomes (1)

  • Change of HbA1c before and after administration of test drug

    20 weeks

Secondary Outcomes (4)

  • Change of self-monitoring of blood glucose before and after administration of test drug

    20 weeks

  • Change of insulin dose before and after administration of test drug

    20 weeks

  • Achievement rate of HbA1c target level (rate of the patients whose HbA1c were improved under 6.5% after administration)

    20 weeks

  • Change of CRP, 8-OHdG and Nitrotyrosine before and after administration of test drug

    20 weeks

Study Arms (2)

M

EXPERIMENTAL

Mitiglinide

Drug: Mitiglinide

V

ACTIVE COMPARATOR

Voglibose

Drug: Voglibose

Interventions

MitiglinideDRUG

mitiglinide 10mg three times a day before a meal

Also known as: Glufast
M
VogliboseDRUG

voglibose 0.2mg three times a day before a meal

Also known as: Basen
V

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The type 2 diabetic patients aged between 30 and 70
  • The patients whose Hb1Ac is over 7.0% despite administration of two or more oral antidiabetic drugs over 6 months or only insulin glargine over 3 months before registration
  • Outpatients whose BMI is between 21 and 40 kg/㎡
  • The patients who consented to participate in the clinical study in writing

You may not qualify if:

  • The patients who have been using insulin formulation except insulin glargine
  • The patients whose fasting blood glucose is over 270 mg/dL
  • The patients whose C-peptide is under 1ng/ml on an empty stomach
  • The patients who was surgically operated of gastrointestinal tract
  • The patients who need additional treatment or who underwent operation within 3 months for severe complication such as diabetic foot ulcer, retinopathy and neuropathy
  • The patients with severe hepatic dysfunction : uncompensated hepatic cirrhosis, or the case where aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is over 2.5 times higher than the normal limit ( ≥ 2.5 x normal ranges)
  • The patients with unstable angina or acute myocardial infarction occurred within 3months
  • The patients with renal failure or severe hypertension : diastolic blood pressure is over 110mmHg despite drug treatment
  • The patients who have a life-threatening disease such as cancer or severe infection
  • The patients with a history of drug allergy
  • Pregnant or breast feeding or the women who are likely to be pregnant
  • The patients who need oral or parenteral corticosteroids
  • The patients who were judged to be unsuitable to the clinical study by other reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital

Seoul, 137-701, South Korea

Location

Related Publications (1)

  • Son JW, Lee IK, Woo JT, Baik SH, Jang HC, Lee KW, Cha BS, Sung YA, Park TS, Yoo SJ, Yoon KH. A prospective, randomized, multicenter trial comparing the efficacy and safety of the concurrent use of long-acting insulin with mitiglinide or voglibose in patients with type 2 diabetes. Endocr J. 2015;62(12):1049-57. doi: 10.1507/endocrj.EJ15-0325. Epub 2015 Sep 25.

    PMID: 26411328DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

mitiglinidevoglibose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kun-ho Yoon

    The Catholic Univ. of Korea, Kangnam ST. Mary's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 22, 2008

Study Start

February 1, 2008

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

March 30, 2012

Record last verified: 2012-03

Locations

KR(1)