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Lantus in Prediabetes

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperglycemia; Diabetes Mellitus

Intervention: Lantus® (insulin glargine) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Peter JOHNSTON, MD, Study Director, Affiliation: Sanofi

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Efficacy: 8-point blood glucose measurements.

Safety / tolerability: hypoglycemia

Secondary outcome:

Blood glucose in response to exercise.

Fasting supine levels of counterregulatory hormones

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Sanofi-Aventis, Bridgewater, New Jersey 08807, United States
Additional Information

Starting date: February 2002
Last updated: July 4, 2006

Page last updated: August 23, 2015

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