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

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 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:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

Drug Information available for: Insulin Insulin human Insulin glargine

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) ]

Secondary Outcome Measures:

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


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 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on July 25, 2017