Study To Evaluate Beta Cell Function and Glycemic Outcome by Intensive Insulin Therapy

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized controlled prospective study aims to evaluate the efficacy of intensive insulin therapy for long term glycemic control and improvement or preservation of beta cell function in newly diagnosed type 2 diabetes patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyunghee University Medical Center
• Collaborators: Ajou University; East West Neo Medical Center; Hanyang University; Inha University Hospital; Jeju National University Hospital; Korea University Guro Hospital; Sanofi; The Catholic University of Korea
• Treatments: Glimepiride; Hypoglycemic Agents; Insulin; Insulin, Globin Zinc; Metformin

Criteria

Inclusion Criteria:

• Newly diagnosed drug naïve type 2 diabetic patient with typical diabetic symptom (polydipsia, polyuria, unexplained weight loss) within recent 1 year

• Initial HbA1c : 8.0 % ≤ HbA1c < 12.0%

Exclusion Criteria:

• Known contraindication to insulin glargine, insulin glulisine, metformin, glimepiride

• Patients with proliferative diabetic retinopathy

• Severe liver disease or AST, ALT ≥ 2.5 x ULN

• History of lactic acidosis

• Unstable or severe angina

• Congestive heart failure

• Chronic disease treated with continuous corticosteroid therapy

• Diagnosis of cancer

• Positive urine pregnancy test or plan to become pregnant during the clinical trial