Insulin Glulisine in Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Insulin Glulisine
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Maximum plasma glucose concentration (GLUmax, mmol/L)
Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L)
Time to GLUmax (Tmax, min)
Secondary Outcome Measures
Area under the insulin concentration-time curve after injection(μIU.min/mL)
Maximum concentration (Cmax, μIU/mL)
Adverse events collection
Time to maximum concentration (Tmax, min)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00310297
Brief Title
Insulin Glulisine in Type 2 Diabetes Mellitus
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Insulin Glulisine
Primary Outcome Measure Information:
Title
Maximum plasma glucose concentration (GLUmax, mmol/L)
Time Frame
During the Study Conduct
Title
Maximum plasma glucose excursion (baseline subtracted glucose concentration, ΔGLUmax, mmol/L)
Time Frame
during the study conduct
Title
Time to GLUmax (Tmax, min)
Time Frame
during the study conduct
Secondary Outcome Measure Information:
Title
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)
Title
Maximum concentration (Cmax, μIU/mL)
Time Frame
During the study conduct
Title
Adverse events collection
Time Frame
from the inform consnet signed up to the end of the study
Title
Time to maximum concentration (Tmax, min)
Time Frame
During the study conduct
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie Pilorget, MD
Organizational Affiliation
Sanofi
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Insulin Glulisine in Type 2 Diabetes Mellitus
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