A Phase 3 interventional study of Lantus (insulin glargine [rDNA origin] injection) and Humulin N in Diabetes Mellitus, sponsored by Sanofi. Completed at 1 site in United States. Open to participants aged 9 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-01-11.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
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)
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 250 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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to measure change in glycemic control as measured by hemoglobin A1c (A1c).
Time frame: from baseline to endpoint (last available post-treatment assessment)
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
This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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