Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes Adolescents
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ClinicalTrials.gov Identifier: NCT00046501 |
Recruitment Status :
Completed
First Posted : October 2, 2002
Last Update Posted : January 11, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus | Drug: Lantus (insulin glargine [rDNA origin] injection) Drug: Humulin N Drug: Humulin L Drug: Lispro | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 250 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | November 2002 |
Actual Primary Completion Date : | February 2005 |

- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 9 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00046501
United States, New Jersey | |
Aventis | |
Bridgewater, New Jersey, United States, 08807 |
Study Director: | Doug Green | Sanofi |
Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00046501 |
Other Study ID Numbers: |
HOE901_4030 |
First Posted: | October 2, 2002 Key Record Dates |
Last Update Posted: | January 11, 2011 |
Last Verified: | January 2011 |
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin Insulin Glargine |
Insulin, Globin Zinc Insulin, Isophane Isophane Insulin, Human Hypoglycemic Agents Physiological Effects of Drugs |