Lantus in Prediabetes - Tabular View

Tracking Information

First Received Date ^ICMJE

July 4, 2006

Last Updated Date

July 4, 2006

Start Date ^ICMJE

February 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Lantus in Prediabetes

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hyperglycemia
Diabetes Mellitus

Intervention ^ICMJE

Drug: Lantus® (insulin glargine)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00348972

Responsible Party

Study ID Numbers ^ICMJE

HOE901/1021, HOE901

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Peter JOHNSTON, MD

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

July 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP