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OpenTrials
Completed

NCT Number: NCT00046501

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

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)

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aventis

Bridgewater, New Jersey, 08807, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lantus (insulin glargine [rDNA origin] injection)

Drug

Humulin N

Drug

Humulin L

Drug

Lispro

Drug

Primary outcomes

  1. 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

  1. Change in A1c

    Time frame: from baseline to individual study time points

  2. 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

  3. Change in fasting self-monitored blood glucose (SMBG) for weekdays, weekends and weekday/weekend combined

    Time frame: from baseline to endpoint

  4. Change in urinary spot random microalbumin-to-creatinine (A/C) ratio

    Time frame: from baseline to endpoint

  5. Change in 8-point blood glucose profiles for weekdays, weekends, and weekday/weekend combined

    Time frame: from baseline to endpoint

  6. Change in average basal insulin doses

    Time frame: from baseline to endpoint

  7. 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

  8. Change in glucose

    Time frame: from baseline to endpoint

  9. Occurrence of hypoglycemia

    Time frame: from the informed consent signature to the end of the study

  10. Adverse events (AEs)

    Time frame: from the informed consent signature to the end of the study

  11. 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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2005
First posted
Oct 2, 2002
Registry last updated
Jan 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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