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Characteristics of Glargine in Type 2 Diabetics

NCT00574912 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-04-17

Study results available
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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.

Conditions

Interventions

DRUG

Placebo

single dose of Placebo injected s/c at 8am and monitor blood glucose over 24 hours

DRUG

Insulin Glargine 0.5 u/kg body wt SC

8 weeks later, a differing dose (0.5, 1.0, 1.5, 2.0 u/kg body wt.) of Insulin Glargine and monitoring over a 24 hour period each separated by 8 weeks (5 separate study visits)

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

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Stephen N. Davis, MD, FRCP · Vanderbilt University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-09-30
Completion
2010-01-31

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00574912 on ClinicalTrials.gov