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Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes Adolescents

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00046501
First received: September 30, 2002
Last updated: January 10, 2011
Last verified: January 2011
History of Changes
  Purpose

The purpose of the study is to compare the effect in blood sugar control between Lantus and twice daily intermediate acting insulins (NPH or Lente) when used as the basal insulin in a multiple daily injection setting with fast acting insulin (Lispro)


Condition Intervention Phase
Diabetes Mellitus
 Drug: Lantus (insulin glargine [rDNA origin] injection)
Drug: Humulin N
Drug: Humulin L
Drug: Lispro
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Morning LANTUS v. Intermediate-acting Insulin 2x/Day as Basal Insulin in a Multiple Daily Inj. w/ Humalog in Adolescents w/ Type 1 Diabetes Mellitus: an Active-controlled, Open, Randomized, Gender-stratified, Two-arm, Parallel-group Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • to measure change in glycemic control as measured by hemoglobin A1c (A1c). [ Time Frame: from baseline to endpoint (last available post-treatment assessment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in A1c [ Time Frame: from baseline to individual study time points ] [ Designated as safety issue: No ]
  • Percentage of subjects achieving an A1c ≤7.0; percent of preteens (12 years and below) achieving 8%; teens (13-18 years) achieving 7.5% [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Change in fasting self-monitored blood glucose (SMBG) for weekdays, weekends and weekday/weekend combined [ Time Frame: from baseline to endpoint ] [ Designated as safety issue: No ]
  • Change in urinary spot random microalbumin-to-creatinine (A/C) ratio [ Time Frame: from baseline to endpoint ] [ Designated as safety issue: No ]
  • Change in 8-point blood glucose profiles for weekdays, weekends, and weekday/weekend combined [ Time Frame: from baseline to endpoint ] [ Designated as safety issue: No ]
  • Change in average basal insulin doses [ Time Frame: from baseline to endpoint ] [ Designated as safety issue: No ]
  • Change in lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL], low-density lipoprotein cholesterol [LDL], and triglycerides [TGs]) [ Time Frame: from baseline to endpoint ] [ Designated as safety issue: No ]
  • Change in glucose [ Time Frame: from baseline to endpoint ] [ Designated as safety issue: No ]
  • Occurrence of hypoglycemia [ Time Frame: from the informed consent signature to the end of the study ] [ Designated as safety issue: No ]
  • Adverse events (AEs) [ Time Frame: from the informed consent signature to the end of the study ] [ Designated as safety issue: No ]
  • Clinical values: physical examination, vital signs, change in age-adjusted body mass index (BMI) [ Time Frame: from the informed consent signature to the end of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: November 2002
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   9 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 1 diabetes treated with insulin only for at least 1 year,
  • with a Tanner stage of ≥ 2,
  • had evidence of decreased insulin secretory capacity (fasting C-peptide concentration ≤0.5 mmol/L) and 7.0%≤A1c≤9.5% at screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046501

Locations
United States, New Jersey
Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Doug Green Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00046501     History of Changes
Other Study ID Numbers: HOE901_4030
Study First Received: September 30, 2002
Last Updated: January 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013