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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00046501
Recruitment Status : Completed
First Posted : October 2, 2002
Last Update Posted : January 11, 2011
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Lantus (insulin glargine [rDNA origin] injection) Drug: Humulin N Drug: Humulin L Drug: Lispro Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2002
Actual Primary Completion Date : February 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. to measure change in glycemic control as measured by hemoglobin A1c (A1c). [ Time Frame: from baseline to endpoint (last available post-treatment assessment) ]

Secondary Outcome Measures :
  1. Change in A1c [ Time Frame: from baseline to individual study time points ]
  2. 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 ]
  3. Change in fasting self-monitored blood glucose (SMBG) for weekdays, weekends and weekday/weekend combined [ Time Frame: from baseline to endpoint ]
  4. Change in urinary spot random microalbumin-to-creatinine (A/C) ratio [ Time Frame: from baseline to endpoint ]
  5. Change in 8-point blood glucose profiles for weekdays, weekends, and weekday/weekend combined [ Time Frame: from baseline to endpoint ]
  6. Change in average basal insulin doses [ Time Frame: from baseline to endpoint ]
  7. 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 ]
  8. Change in glucose [ Time Frame: from baseline to endpoint ]
  9. Occurrence of hypoglycemia [ Time Frame: from the informed consent signature to the end of the study ]
  10. Adverse events (AEs) [ Time Frame: from the informed consent signature to the end of the study ]
  11. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00046501


Locations
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United States, New Jersey
Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Doug Green Sanofi
More Information
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Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00046501    
Other Study ID Numbers: HOE901_4030
First Posted: October 2, 2002    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin Glargine
 Insulin, Globin Zinc
Insulin, Isophane
Isophane Insulin, Human
Hypoglycemic Agents
Physiological Effects of Drugs