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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00046501

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin lispro Insulin glargine

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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-Aventis

Investigators

Study Director:

Doug Green

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	HOE901/4030
Study First Received:	September 30, 2002
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00046501 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Insulin LISPRO
Diabetes Mellitus Type 1
Insulin

Insulin, Isophane
Hypoglycemic Agents
Diabetes Mellitus, Type 1
Glargine
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Physiological Effects of Drugs

Glargine
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on July 02, 2009