Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes Adolescents
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00046501
First received: September 30, 2002
Last updated: January 10, 2011
Last verified: January 2011
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Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus |
Drug: Lantus (insulin glargine [rDNA origin] injection) Drug: Humulin N Drug: Humulin L Drug: Lispro |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 250 |
| Study Start Date: | November 2002 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 9 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046501
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046501
Locations
| United States, New Jersey | |
| Aventis | |
| Bridgewater, New Jersey, United States, 08807 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Doug Green | Sanofi |
More Information
No publications provided
| Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00046501 History of Changes |
| Other Study ID Numbers: | HOE901_4030 |
| Study First Received: | September 30, 2002 |
| Last Updated: | January 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Insulin |
Insulin, Globin Zinc Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015