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

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Sanofi

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00046501
HOE901_4030

Details and patient eligibility

About

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)

Sex

All

Ages

9 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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