NCT00348972

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2006

Completed
Last Updated

July 6, 2006

Status Verified

July 1, 2006

First QC Date

July 4, 2006

Last Update Submit

July 4, 2006

Conditions

HyperglycemiaDiabetes Mellitus

Keywords

Glargineprediabetesimpaired glucose toleranceimpaired fasting glucose

Outcome Measures

Primary Outcomes (2)

  • Efficacy: 8-point blood glucose measurements.

  • Safety / tolerability: hypoglycemia

Secondary Outcomes (2)

  • Blood glucose in response to exercise.

  • Fasting supine levels of counterregulatory hormones

Interventions

Lantus® (insulin glargine)DRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hyperglycemia (either IGT , IFG, or untreated type 2 diabetes)
  • HbA1c \< 7.0%
  • BMI \< 40kg/m2
  • Able to perform moderate stationary bicycle exercise

You may not qualify if:

  • Chronic pharmacologic treatment for hyperglycemia, past or present
  • CAD
  • serum creatinine \> 2.0mg/dL
  • BP \> 180/105
  • History of hypoglycemia unawareness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

Related Links

MeSH Terms

Conditions

HyperglycemiaDiabetes MellitusPrediabetic StateGlucose Intolerance

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Peter JOHNSTON, MD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 4, 2006

First Posted

July 6, 2006

Study Start

February 1, 2002

Last Updated

July 6, 2006

Record last verified: 2006-07

Locations

US(1)