Insulin Glulisine in Type 2 Diabetes Mellitus - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00310297

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Insulin Glulisine	Phase I

MedlinePlus related topics: Diabetes Obesity

Drug Information available for: Insulin Insulin lispro Insulin glulisine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official 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.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Maximum plasma glucose concentration (GLUmax, mmol/L) [ Time Frame: During the Study Conduct ] [ Designated as safety issue: No ]
Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L) [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
Time to GLUmax (Tmax, min) [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]
Maximum concentration (Cmax, μIU/mL) [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Adverse events collection [ Time Frame: from the inform consnet signed up to the end of the study ] [ Designated as safety issue: No ]
Time to maximum concentration (Tmax, min) [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Study Start Date:	November 2004
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310297

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Valérie Pilorget, MD

Sanofi-Aventis

More Information

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	HMR1964A/1505
Study First Received:	March 2, 2006
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00310297
Health Authority:	United Kingdom: National Health Service

Study placed in the following topic categories:

Obesity
Insulin glulisine
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Insulin LISPRO

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009