Insulin Glulisine in Type 2 Diabetes Mellitus

NCT00310297 | Completed Phase 1

• 1 other identifier: HMR1964A_1505
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Maximum plasma glucose concentration (GLUmax, mmol/L)

  During the Study Conduct

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

  during the study conduct

• Time to GLUmax (Tmax, min)

  during the study conduct

Secondary Outcomes (4)

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

  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)

• Maximum concentration (Cmax, μIU/mL)

  During the study conduct

• Adverse events collection

  from the inform consnet signed up to the end of the study

• Time to maximum concentration (Tmax, min)

  During the study conduct

Interventions

Insulin Glulisine DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin glulisine

Condition Hierarchy (Ancestors)

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

Study Officials

• Valérie Pilorget, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 2, 2006
• First Posted: April 3, 2006
• Study Start: November 1, 2004
• Primary Completion: December 1, 2004
• Last Updated: January 11, 2011

Record last verified: 2008-07