Insulin Glulisine in Type 2 Diabetes Mellitus

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00310297

First received: March 2, 2006

Last updated: January 10, 2011

Last verified: July 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

March 2, 2006

Last Updated Date

January 10, 2011

Start Date ^ICMJE

November 2004

Primary Completion Date

December 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00310297 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Insulin Glulisine in Type 2 Diabetes Mellitus

Official Title ^ICMJE

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.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: Insulin Glulisine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

December 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00310297

Other Study ID Numbers ^ICMJE

HMR1964A_1505

Has Data Monitoring Committee

Not Provided

Responsible Party

Medical Affairs Study Director, sanofi-aventis

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Valérie Pilorget, MD

Sanofi

Information Provided By

Sanofi

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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