Glufast On Insulin Glargine Trial in Type 2 DM

NCT ID: NCT00663884

Last Updated: 2012-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-09-30

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes mellitus, Type 2; mitiglinide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

M

Mitiglinide

Group Type: EXPERIMENTAL

Mitiglinide

Intervention Type: DRUG

mitiglinide 10mg three times a day before a meal

V

Voglibose

Group Type: ACTIVE_COMPARATOR

Voglibose

Intervention Type: DRUG

voglibose 0.2mg three times a day before a meal

Interventions

Mitiglinide

mitiglinide 10mg three times a day before a meal

Intervention Type: DRUG

Voglibose

voglibose 0.2mg three times a day before a meal

Intervention Type: DRUG

Other Intervention Names

Glufast; Basen

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JW Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kun-ho Yoon

Role: STUDY_CHAIR

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

Locations

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

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 26411328 (View on PubMed)

Other Identifiers

CWP-KAD-402

Identifier Type: -

Identifier Source: org_study_id