Lantus in Prediabetes

Phase 1

Completed

• Conditions: Hyperglycemia; Diabetes Mellitus

• Registration Number: NCT00348972
• Lead Sponsor: Sanofi

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Status Verified: 2006-07
• Study First Submitted: 2006-07-04
• Study First Submitted QC: 2006-07-04
• Last Update Submitted: 2006-07-04
• Study First Posted: 2006-07-06
• Last Update Posted: 2006-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Hyperglycemia (either IGT , IFG, or untreated type 2 diabetes)
• HbA1c < 7.0%
• BMI < 40kg/m2
• Able to perform moderate stationary bicycle exercise

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Exclusion Criteria

• Chronic pharmacologic treatment for hyperglycemia, past or present
• CAD
• serum creatinine > 2.0mg/dL
• BP > 180/105
• History of hypoglycemia unawareness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy: 8-point blood glucose measurements.
Safety / tolerability: hypoglycemia

Secondary Outcome Measures

Name	Time	Method
Blood glucose in response to exercise.
Fasting supine levels of counterregulatory hormones

Trial Locations

Locations (1)

Sanofi-Aventis; 🇺🇸 Bridgewater, New Jersey, United States