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

January 10, 2011 updated by: Sanofi

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in A1c
Time Frame: from baseline to individual study time points
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
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
from baseline to endpoint
Change in urinary spot random microalbumin-to-creatinine (A/C) ratio
Time Frame: from baseline to endpoint
from baseline to endpoint
Change in 8-point blood glucose profiles for weekdays, weekends, and weekday/weekend combined
Time Frame: from baseline to endpoint
from baseline to endpoint
Change in average basal insulin doses
Time Frame: from baseline to endpoint
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
from baseline to endpoint
Change in glucose
Time Frame: from baseline to endpoint
from baseline to endpoint
Occurrence of hypoglycemia
Time Frame: from the informed consent signature to the end of the study
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
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
from the informed consent signature to the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Doug Green, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

September 30, 2002

First Submitted That Met QC Criteria

October 1, 2002

First Posted (Estimate)

October 2, 2002

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOE901_4030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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