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Characteristics of Glargine in Type 2 Diabetics

CompletedPhase 1

Sponsor: Vanderbilt University Medical Center

Conditions: Type 2 Diabetes

Interventions: Placebo, Insulin Glargine 0.5 u/kg body wt SC, Insulin Glargine 1.0 u/kg body wt SC, Insulin Glargine 1.5 u/kg body wt SC, Insulin Glargine 2.0 u/kg body wt SC

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Nashville, Tennessee, United States