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

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Locations

United States, New Jersey
Aventis
Bridgewater, New Jersey, United States, 08807

Sponsors and Collaborators

Sanofi

Investigators

Study Director:	Doug Green	Sanofi

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00046501 History of Changes
Other Study ID Numbers:	HOE901_4030
First Posted:	October 2, 2002
Last Update Posted:	January 11, 2011
Last Verified:	January 2011

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases	Insulin, Globin Zinc; Insulin; Insulin Glargine; Insulin, Isophane; Isophane Insulin, Human; Hypoglycemic Agents; Physiological Effects of Drugs