Phase 1
N=20
Characteristics of Glargine in Type 2 Diabetics
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00574912 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Maximum Glucose Infusion Rate — 0.3; 2.6; 5.5; 6.8 umol/kg/min — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Placebo (Drug); Insulin Glargine 0.5 u/kg body wt SC (Drug); Insulin Glargine 1.0 u/kg body wt SC (Drug); Insulin Glargine 1.5 u/kg body wt SC (Drug); Insulin Glargine 2.0 u/kg body wt SC (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Glucose Infusion Rate |
0.3; 2.6; 5.5; 6.8; 9.5 | <0.05 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT00574912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.