Comparison of Insulin Glargine and NPH Insulin at Night and at Hypoglycemia in Type 2 Diabetes

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Long-acting insulin injected at bedtime may cause hypoglycemia (low blood sugar) in the night in patients with diabetes. The aims of the study are 1) to compare the dynamic characteristics of long-acting insulin analog glargine with those of NPH insulin and placebo during the night and the early morning hours, 2) investigate differences on glucose metabolism of bedtime glargine versus NPH insulin at induced hypoglycemia.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Giessen
• Collaborator: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

• Type 2 Diabetes mellitus

• Therapy may be with either insulin alone or in combination with oral anti-diabetic agents

• Metabolic control with HbA1c values < 10%

Exclusion Criteria:

• Other than type 2 diabetes

• Pregnancy

• Systemic Corticosteroids, Beta-blockers

• Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematological or other major disease making implementation of the protocol or interpretation of the study results difficult

• History of drug or alcohol abuse

• Impaired renal function (serum creatinine > 1.3 mg/dl)