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

Sanofi250 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Diabetes Mellitus

Interventions

Lantus (insulin glargine [rDNA origin] injection)DRUG

Humulin NDRUG

Humulin LDRUG

LisproDRUG

Eligibility

Sex: ALLMin age: 9 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Aventis

Bridgewater, New Jersey, United States

Outcomes

Primary Outcomes

to measure change in glycemic control as measured by hemoglobin A1c (A1c).

Time frame: from baseline to endpoint (last available post-treatment assessment)

Secondary Outcomes

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