| September 30, 2002 |
| October 13, 2009 |
| November 2002 |
| February 2005 (final data collection date for primary outcome measure) |
| to measure change in glycemic control as measured by hemoglobin A1c (A1c). [ Time Frame: from baseline to endpoint (last available post-treatment assessment) ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00046501 on ClinicalTrials.gov Archive Site |
- Change in A1c [ Time Frame: from baseline to individual study time points ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Change in fasting self-monitored blood glucose (SMBG) for weekdays, weekends and weekday/weekend combined [ Time Frame: from baseline to endpoint ] [ Designated as safety issue: No ]
- Change in urinary spot random microalbumin-to-creatinine (A/C) ratio [ Time Frame: from baseline to endpoint ] [ Designated as safety issue: No ]
- Change in 8-point blood glucose profiles for weekdays, weekends, and weekday/weekend combined [ Time Frame: from baseline to endpoint ] [ Designated as safety issue: No ]
- Change in average basal insulin doses [ Time Frame: from baseline to endpoint ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Change in glucose [ Time Frame: from baseline to endpoint ] [ Designated as safety issue: No ]
- Occurrence of hypoglycemia [ Time Frame: from the informed consent signature to the end of the study ] [ Designated as safety issue: No ]
- Adverse events (AEs) [ Time Frame: from the informed consent signature to the end of the study ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes Adolescents |
| 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 |
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) |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Diabetes Mellitus |
- Drug: Lantus (insulin glargine [rDNA origin] injection)
- Drug: Humulin N
- Drug: Humulin L
- Drug: Lispro
|
| |
| |
| |
| Completed |
| 250 |
|
| February 2005 (final data collection date for primary outcome measure) |
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. |
| Both |
| 9 Years to 17 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00046501 |
| Medical Affairs Study Director, sanofi-aventis |
| HOE901/4030 |
| Sanofi-Aventis |
|
| Study Director: |
Doug Green |
Sanofi-Aventis |
|
|
| Sanofi-Aventis |
| October 2009 |
