Clinical trial NCT00046501: Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes Adolescents
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2002-10-02
Enrollment: 250
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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.

Primary outcomes:
measure: to measure change in glycemic control as measured by hemoglobin A1c (A1c).
timeFrame: from baseline to endpoint (last available post-treatment assessment)
Secondary outcomes:
measure: Change in A1c
timeFrame: from baseline to individual study time points
measure: Percentage of subjects achieving an A1c ≤7.0; percent of preteens (12 years and below) achieving 8%; teens (13-18 years) achieving 7.5%
timeFrame: During the study conduct
measure: Change in fasting self-monitored blood glucose (SMBG) for weekdays, weekends and weekday/weekend combined
timeFrame: from baseline to endpoint
measure: Change in urinary spot random microalbumin-to-creatinine (A/C) ratio
timeFrame: from baseline to endpoint
measure: Change in 8-point blood glucose profiles for weekdays, weekends, and weekday/weekend combined
timeFrame: from baseline to endpoint
measure: Change in average basal insulin doses
timeFrame: from baseline to endpoint
measure: Change in lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL], low-density lipoprotein cholesterol [LDL], and triglycerides [TGs])
timeFrame: from baseline to endpoint
measure: Change in glucose
timeFrame: from baseline to endpoint
measure: Occurrence of hypoglycemia
timeFrame: from the informed consent signature to the end of the study
measure: Adverse events (AEs)
timeFrame: from the informed consent signature to the end of the study
measure: Clinical values: physical examination, vital signs, change in age-adjusted body mass index (BMI)
timeFrame: from the informed consent signature to the end of the study
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Aventis
state: New Jersey
Study officials:
affiliation: Sanofi
name: Doug Green
role: STUDY_DIRECTOR
References: