Trial | NCT00663884  Report issue

Title

Glufast On Insulin Glargine Trial in Type 2 DM
A Prospective, Randomized and Multi-center Clinical Study to Evaluate Efficacy and Safety of Combination Therapy of Mitiglinide or Voglibose With Long-acting Insulin in Type 2 Diabetic Patients

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    167
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.
Study Started
Feb 29
2008
Primary Completion
Jul 31
2009
Study Completion
Sep 30
2009
Last Update
Mar 30
2012
Estimate

Drug Mitiglinide

mitiglinide 10mg three times a day before a meal

  • Other names: Glufast

Drug Voglibose

voglibose 0.2mg three times a day before a meal

  • Other names: Basen

M Experimental

Mitiglinide

V Active Comparator

Voglibose

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
No Results Posted