NCT00046501

Brief 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)

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P25-P50 for phase_3 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2002

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2002

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Last Updated

January 11, 2011

Status Verified

January 1, 2011

Enrollment Period

2.3 years

First QC Date

September 30, 2002

Last Update Submit

January 10, 2011

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Interventions

Lantus (insulin glargine [rDNA origin] injection)DRUG
Humulin NDRUG
Humulin LDRUG
LisproDRUG

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aventis

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin GlargineInjectionsIsophane Insulin, Humaninsulin, long-acting, humanInsulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsDrug Administration RoutesDrug TherapyTherapeuticsInsulin, IsophaneInsulin, Regular, HumanInsulinProinsulinInsulin, Short-Acting

Study Officials

  • Doug Green

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 30, 2002

First Posted

October 2, 2002

Study Start

November 1, 2002

Primary Completion

February 1, 2005

Last Updated

January 11, 2011

Record last verified: 2011-01

Locations

US(1)