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NCT00348972 Clinical Trial

Lantus in Prediabetes

Diabetes Mellitus Clinical Trial

Official title:
Assessment of Safety and Tolerability of Lantus® (Insulin Glargine) in Subjects With Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00348972
Other study ID # HOE901/1021
Secondary ID HOE901
Status Completed
Phase Phase 1
First received July 4, 2006
Last updated July 4, 2006
Start date February 2002

Study information
Verified date July 2006
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To assess the safety, tolerability, and efficacy of Lantus® (insulin glargine) in prediabetes (IFG or IGT).

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Hyperglycemia (either IGT , IFG, or untreated type 2 diabetes)

- HbA1c < 7.0%

- BMI < 40kg/m2

- Able to perform moderate stationary bicycle exercise

Exclusion Criteria:

- Chronic pharmacologic treatment for hyperglycemia, past or present

- CAD

- serum creatinine > 2.0mg/dL

- BP > 180/105

- History of hypoglycemia unawareness

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lantus® (insulin glargine)

Locations
Country Name City State
United States Sanofi-Aventis Bridgewater New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy: 8-point blood glucose measurements.
Primary Safety / tolerability: hypoglycemia
Secondary Blood glucose in response to exercise.
Secondary Fasting supine levels of counterregulatory hormones
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