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OpenTrials
Completed

NCT Number: NCT00348972

Lantus in Prediabetes

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

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Key information

Conditions

Hyperglycemia Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lantus® (insulin glargine)

Drug

Primary outcomes

  1. Efficacy: 8-point blood glucose measurements.

  2. Safety / tolerability: hypoglycemia

Secondary outcomes

  1. Blood glucose in response to exercise.

  2. Fasting supine levels of counterregulatory hormones

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2002
First posted
Jul 6, 2006
Registry last updated
Jul 6, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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