Diabetes Mellitus
Conditions
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)
Interventions
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 17 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to measure change in glycemic control as measured by hemoglobin A1c (A1c). | from baseline to endpoint (last available post-treatment assessment) |
Secondary
| Measure | Time frame |
|---|---|
| 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 fasting self-monitored blood glucose (SMBG) for weekdays, weekends and weekday/weekend combined | from baseline to endpoint |
| Change in urinary spot random microalbumin-to-creatinine (A/C) ratio | from baseline to endpoint |
| Change in 8-point blood glucose profiles for weekdays, weekends, and weekday/weekend combined | from baseline to endpoint |
| Change in average basal insulin doses | from baseline to endpoint |
| Change in A1c | from baseline to individual study time points |
| Change in glucose | from baseline to endpoint |
| Occurrence of hypoglycemia | from the informed consent signature to the end of the study |
| Adverse events (AEs) | 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 lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL], low-density lipoprotein cholesterol [LDL], and triglycerides [TGs]) | from baseline to endpoint |
Countries
United States
Outcome results
None listed