Glufast On Insulin Glargine Trial in Type 2 DM (GLORIA)

JW Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Mitiglinide; Drug: Voglibose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00663884

CWP-KAD-402

Details and patient eligibility

About

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.

Enrollment: 167 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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167 participants in 2 patient groups

M

Experimental group

Description:

Mitiglinide

Treatment:

Drug: Mitiglinide

V

Active Comparator group

Description:

Voglibose

Treatment:

Drug: Voglibose