Insulin Glulisine in Type 2 Diabetes Mellitus

Sanofi

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Insulin Glulisine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00310297

HMR1964A_1505

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)