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

Sanofi1 site in 1 country250 target enrollmentNovember 2002

ConditionsDiabetes Mellitus

DrugsLantus (insulin glargine [rDNA origin] injection)Humulin N Humulin L Lispro

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diabetes Mellitus
Sponsor: Sanofi
Enrollment: 250
Locations: 1
Primary Endpoint: to measure change in glycemic control as measured by hemoglobin A1c (A1c).
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

November 2002

End Date

February 2005

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Eligibility 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.

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

to measure change in glycemic control as measured by hemoglobin A1c (A1c).

Time Frame: from baseline to endpoint (last available post-treatment assessment)

Secondary Outcomes

Change in 8-point blood glucose profiles for weekdays, weekends, and weekday/weekend combined(from baseline to endpoint)
Change in lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL], low-density lipoprotein cholesterol [LDL], and triglycerides [TGs])(from baseline to endpoint)
Adverse events (AEs)(from the informed consent signature to the end of the study)
Change in A1c(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%(During the study conduct)
Change in urinary spot random microalbumin-to-creatinine (A/C) ratio(from baseline to endpoint)
Change in average basal insulin doses(from baseline to endpoint)
Change in glucose(from baseline to endpoint)
Occurrence of hypoglycemia(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)(from the informed consent signature to the end of the study)
Change in fasting self-monitored blood glucose (SMBG) for weekdays, weekends and weekday/weekend combined(from baseline to endpoint)