Glufast On Insulin Glargine Trial in Type 2 DM

Launched by JW PHARMACEUTICAL · Apr 21, 2008

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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