Lantus in Prediabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Brief Summary

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

Detailed Description

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Conditions

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Hyperglycemia Diabetes Mellitus

Keywords

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Glargine prediabetes impaired glucose tolerance impaired fasting glucose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Lantus® (insulin glargine)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Peter JOHNSTON, MD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Bridgewater, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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HOE901

Identifier Type: -

Identifier Source: secondary_id

HOE901/1021