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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00046501
• Other study ID #: HOE901_4030
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2002
• Last updated: January 10, 2011
• Start date: November 2002

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. primary completion date: February 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Lantus (insulin glargine [rDNA origin] injection)

• Humulin N

• Humulin L

• Lispro

Locations

Country	Name	City	State
United States	Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to measure change in glycemic control as measured by hemoglobin A1c (A1c).		from baseline to endpoint (last available post-treatment assessment)	No
Secondary	Change in A1c		from baseline to individual study time points	No
Secondary	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	No
Secondary	Change in fasting self-monitored blood glucose (SMBG) for weekdays, weekends and weekday/weekend combined		from baseline to endpoint	No
Secondary	Change in urinary spot random microalbumin-to-creatinine (A/C) ratio		from baseline to endpoint	No
Secondary	Change in 8-point blood glucose profiles for weekdays, weekends, and weekday/weekend combined		from baseline to endpoint	No
Secondary	Change in average basal insulin doses		from baseline to endpoint	No
Secondary	Change in lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL], low-density lipoprotein cholesterol [LDL], and triglycerides [TGs])		from baseline to endpoint	No
Secondary	Change in glucose		from baseline to endpoint	No
Secondary	Occurrence of hypoglycemia		from the informed consent signature to the end of the study	No
Secondary	Adverse events (AEs)		from the informed consent signature to the end of the study	No
Secondary	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	No