Lantus in Prediabetes

Phase 1CompletedNCT00348972

Sanofi20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hyperglycemia Diabetes Mellitus

Interventions

Lantus® (insulin glargine)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Sanofi-Aventis

Bridgewater, New Jersey, United States

Outcomes

Primary Outcomes

Efficacy: 8-point blood glucose measurements.

Safety / tolerability: hypoglycemia

Secondary Outcomes

Blood glucose in response to exercise.

Fasting supine levels of counterregulatory hormones

Data from ClinicalTrials.gov

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