Back to resultsLantus in Prediabetes
Primary Purpose
Hyperglycemia, Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lantus® (insulin glargine)
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia focused on measuring Glargine, prediabetes, impaired glucose tolerance, impaired fasting glucose
Eligibility Criteria
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
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
Efficacy: 8-point blood glucose measurements.
Safety / tolerability: hypoglycemia
Secondary Outcome Measures
Blood glucose in response to exercise.
Fasting supine levels of counterregulatory hormones
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00348972
Brief Title
Lantus in Prediabetes
Official Title
Assessment of Safety and Tolerability of Lantus® (Insulin Glargine) in Subjects With Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
To assess the safety, tolerability, and efficacy of Lantus® (insulin glargine) in prediabetes (IFG or IGT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Diabetes Mellitus
Keywords
Glargine, prediabetes, impaired glucose tolerance, impaired fasting glucose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lantus® (insulin glargine)
Primary Outcome Measure Information:
Title
Efficacy: 8-point blood glucose measurements.
Title
Safety / tolerability: hypoglycemia
Secondary Outcome Measure Information:
Title
Blood glucose in response to exercise.
Title
Fasting supine levels of counterregulatory hormones
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter JOHNSTON, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.sanofi-aventis.com
Description
Related Info
Learn more about this trial
Lantus in Prediabetes
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