Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes Adolescents

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Lantus (insulin glargine [rDNA origin] injection)
* Drug: Humulin N
* Drug: Humulin L
* Drug: Lispro


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lantus (insulin glargine [rDNA origin] injection)|nan|
|Drug: Humulin N|nan|
|Drug: Humulin L|nan|
|Drug: Lispro|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to measure change in glycemic control as measured by hemoglobin A1c (A1c). |  | from baseline to endpoint (last available post-treatment assessment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in A1c |  | 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% |  | 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 lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL], low-density lipoprotein cholesterol [LDL], and triglycerides [TGs]) |  | from baseline to endpoint | 
| 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 |