Insulin Glulisine in Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310297
• Other study ID #: HMR1964A_1505
• Status: Completed
• Phase: Phase 1
• First received: March 2, 2006
• Last updated: January 10, 2011
• Start date: November 2004

Study information

• Verified date: July 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin Glulisine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma glucose concentration (GLUmax, mmol/L)		During the Study Conduct	No
Primary	Maximum plasma glucose excursion (baseline subtracted glucose concentration, ?GLUmax, mmol/L)		during the study conduct	No
Primary	Time to GLUmax (Tmax, min)		during the study conduct	No
Secondary	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)	No
Secondary	Maximum concentration (Cmax, µIU/mL)		During the study conduct	No
Secondary	Adverse events collection		from the inform consnet signed up to the end of the study	No
Secondary	Time to maximum concentration (Tmax, min)		During the study conduct	No