Characteristics of Glargine in Type 2 Diabetics

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is to determine the dose response relationship of insulin glargine in type 2 diabetes over a 24-hour period and measuring the differences in glucose production among the differing doses of glargine.

Hypothesis: Differing doses of insulin glargine over a 24-hour period in type 2 diabetes will show differing effects on endogenous glucose production, glucose disposal and carbohydrate and lipid flux.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Collaborator: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• 12 adults (males or females) with type 2 diabetes for at least six (6) months. May be using oral agents (SUs, metformin, acarbose or glitinides) with or without insulin.

• HgbA1c 7 -12%

• Age 18-70 years

• BMI 27-40 kg/m²

Exclusion Criteria:

• Any past or present clinically relevant abnormality, medical condition, or circumstance making the subject unsuitable for participation in the study

• Evidence of hepatic, renal or cardiac failure

• Abnormal results following screening tests

• Pregnant or lactating females or females of childbearing potential who are unwilling to abstain from sexual intercourse or use reliable, medically accepted methods of contraception

• Currently using TZDs

• History of alcoholism or drug abuse within 12 months of the study