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Completed

NCT Number: NCT00310297

Insulin Glulisine in Type 2 Diabetes Mellitus

Primary objective:

To compare the pharmacodynamics of insulin glulisine and insulin lispro injected subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects with type 2 diabetes.

Secondary objectives:

* To compare the pharmacokinetics of insulin glulisine and insulin lispro in obese subjects with type 2 diabetes, injected subcutaneously before three standard meals during a 12-hour day. * The safety of insulin glulisine, the relationship of the pharmacodynamics and pharmacokinetics with skin thickness and C-peptide, non-esterified fatty acid, triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes mellitus
  • Body mass index (BMI) between 35 and 40 kg/m2
  • HbA1c ≤10%
  • Plasma C-peptide levels ≥0.1 nmol/L.
  • Female subjects have to either be postmenopausal, surgically sterilized, or not pregnant and using approved methods of contraception.

Exclusion criteria

  • Type 1 diabetes mellitus, as defined by the World Health Organization
  • Subjects currently taking any insulin
  • History of hypoglycaemic unawareness
  • Injection site skin thickness < or = 8 mm
  • Contra-indications from
  • The medical history and physical examination
  • Laboratory tests (haematology, clinical chemistry, and urinalysis by dipstick)
  • Blood pressure and pulse

Treatment and study plan

insulin glulisine

Drug

Primary outcomes

  1. Maximum plasma glucose concentration (GLUmax, mmol/L)

    Time frame: During the Study Conduct

  2. Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L)

    Time frame: during the study conduct

  3. Time to GLUmax (Tmax, min)

    Time frame: during the study conduct

Secondary outcomes

  1. Area under the insulin concentration-time curve after injection(μIU.min/mL)

    Time frame: between 0 h and 1 h (AUC0-1h), 0 h and 1.5 h (AUC0-1.5h), 0 h and 2 h (AUC0-2h) and 0 h and 4 h (AUC0-4h)

  2. Maximum concentration (Cmax, μIU/mL)

    Time frame: During the study conduct

  3. Adverse events collection

    Time frame: from the inform consnet signed up to the end of the study

  4. Time to maximum concentration (Tmax, min)

    Time frame: During the study conduct

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Randomized, Open Label, Two-arm, Cross-over Design Study to Compare the Pharmacodynamics and Pharmacokinetics of Insulin Glulisine and Insulin Lispro in Obese Patients With Type 2 Diabetes.

Important dates

Study start
2004
Primary completion
2004
First posted
Apr 3, 2006
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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