Diabetes Mellitus Type 2
Conditions
Brief summary
Primary objective: The primary study objective is to compare efficacy of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of change in HbA1c, from baseline to endpoint for the individual patient. The aim of the study is to demonstrate two-sided equivalence between the two therapy regimens receiving two different injection timing of Insulin glulisine. Secondary objective: Secondary study objectives are to compare efficacy and safety of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of: * Change of fasting-, pre-/2h-postprandial-, mean daily and nocturnal blood glucose (baseline to endpoint) * Change of fasting plasma glucose (baseline to endpoint) * Response rate: Responders will be those patients with HbA1c smaller than 7.0% at study endpoint * Insulin dose (rapid-acting, basal and total daily doses) * Weight, body-mass index * Hypoglycemic events * Adverse events
Interventions
DRUGInsulin glulisine
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 Diabetes mellitus, previously treated with combination therapy of insulin glargine + OAD (maximal tolerated dose / approved in combination with insulin according to local SPCs (Summary of Product Characteristics), not including use of a-glucosidase inhibitors) for at least 3 months * Pre-screening HbA1c value greater/equal 7% - smaller/equal 9% * FBG (Fasting Blood Glucose) smaller/equal 120 mg/dl (6.6 mmol/l) * Women are either not of childbearing potential (surgically sterile, or postmenopausal for more than 2 years) or are not 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. * Ability and willingness to perform blood glucose monitoring using the sponsor-provided blood glucose meter and subject diary at home
Exclusion criteria
* More than two FBG greater 120 mg/dl (6.6 mmol/l) as measured on 5 consecutive days before visit II * 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) * Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult * Known impaired hepatic and renal function * History of drug or alcohol abuse * History of hypersensitivity to insulin or insulin analogues or any of the excipients in the Insulin glulisine formulation * Treatment with any investigational drug in the last month before visit I * Pregnant or breast-feeding women, or women planning to become pregnant during the study * Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol * Night shift workers if they are unable to comply with the treatment regimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c. | from baseline to study endpoint. |
Secondary
| Measure | Time frame |
|---|---|
| Fasting blood glucose | 8-point blood glucose profile values |
| Responder rate HbA1c smaller 7 % | at study endpoint |
| Insulin dose | rapid-acting, basal and total daily doses |
| Change of pre-, 2 h postprandial and nocturnal blood glucose values | 8-point profile |
| Hypoglycemic events | study follow-up |
| Adverse events. | study follow-up |
| Weight, BMI | study follow-up |
Countries
Germany
Outcome results
None listed