Diabetes mellitus type 2 Classification code 10012613
Conditions
Interventions
Trade Name: Apidra
Product Name: Apidra
Product Code: HMR1964
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulin glulisine
Current Sponsor code: HMR1964
Concentration unit: IU/ml
Sponsors
Sanofi-Aventis Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes mellitus, as defined by the American Diabetes Association for at least five years, treated with insulin for at least 6 months (no history of ketoacidosis). 2. Men or women aged 18 to 75 years old, inclusive. 3. HbA1c between 7.5% and 11.0%, inclusive, at both pre-screening and pre-randomization (week -2). 4. For at least 3 months prior to week –8 visit, subjects must have been on a stable insulin regimen with two daily s.c. injections of premixed insulin: NPH plus regular insulin or NPH plus rapid acting insulin (insulin lispro or insulin aspart) in a mixture of 70/30 or 75/25. “Stable” means no change in regimen and no more than 30 % change in dose. Optionally, the subject can have been treated in addition with metformin according to its current official product information leaflet, treatment with other oral blood glucose lowering drugs is not allowed. 5. Documentation of a full ophthalmologic exam (incl. fundoscopy), by an ophthalmologist, during the 6 months prior to randomization. For exclusion criteria refer to exclusion criterion 7. 6. Women are either not of childbearing potential (surgically sterile, or postmenopausal for more than 2 years). Women of childbearing potential must not be pregnant and agree to use a reliable contraceptive measure for the duration of the study. Reliable contraceptive measures include the following: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device or condom with spermicide. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Two or more severe hypoglycemic episodes within the past 3 months, or any hospitalization or emergency room visit due to poor diabetic control within the past 3 months prior to randomization. 2. History of hypoglycemia unawareness. 3. Impaired hepatic function, as shown by, but not limited to, ALAT (SGPT) or ASAT (SGOT) above 2x the upper limit of normal as measured at visit 1. 4. Impaired renal function, as shown by, but not limited to, serum creatinine > 177 mmol/l (> 2 mg/dl) as measured at visit 1 (if no lower values due to individual metformin intake are required) or current renal dialysis. 5. Body mass index (BMI) > 38 kg/m². 6. Any other clinically significant abnormalities on screening laboratory evaluation (unless discussed with the monitor and approved by the study management). 7. Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation) during the study. 8. History of hypersensitivity to insulin or insulin analogues or any of the excipients in the HMR 1964 formulation. 9. Donation of blood or transfusion during the 2 months prior to the screening visit. 10. Pregnant or lactating women, or women planning to become pregnant during the study. 11. Treatment with any investigational drug in the last month before visit 1 (screening).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective is to demonstrate superior efficacy of an intensified insulin regimen with insuline glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of change in glycated hemoglobin A1c (HbA1c), from baseline to endpoint.;Secondary Objective: Secondary study objectives are to compare the intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of blood glucose (BG) values (fasting, pre-/postprandial (ppBG), nocturnal, mean daily), daily BG profiles, BG and HbA1c response rates (predefined), hypoglycemic events, adverse events, change of late diabetes complications, weight, body-mass-index, course of total daily insulin dose and adjustment, blood lipid profile, microalbuminuria, standard lab and quality of life/treatment satisfaction.;Primary end point(s): Change in HbA1c from baseline to endpoint. | — |
Countries
Czech Republic, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed