Diabetes Mellitus, Type 2
Conditions
Brief summary
Study Primary Objectives: To compare glycemic control, as measured by hemoglobin A1c (A1C), between insulin glargine and 75% insulin lispro protamine suspension/25% insulin lispro as add-on therapies in subjects who failed oral combination therapy with sulfonylurea and metformin. Study Secondary Objectives : To compare the following measures between subjects receiving insulin glargine or 75% insulin lispro protamine suspension/25% insulin lispro: * Incidence of hypoglycemia * Change in weight * Change in serum lipid profile * Percentage of subjects achieving A1C levels ≤7%
Detailed description
The planned duration of enrollment is 6 months. The study consists of 2 weeks screening phase and a study period that was planned to be 24 weeks.
Interventions
DRUGInsulin glargine
solution for subcutaneous injection
DRUG75% insulin lispro protamine suspension and 25 % insulin lispro injection
suspension for subcutaneous injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have given their signed informed consent. * Males or females between 18 and 79 years of age. * Diagnosis of type 2 diabetes mellitus for at least one year. * Patients must have had continuous oral hypoglycemic treatment for at least three months using dosing of: at least half maximally labeled dose of sulfonylurea + at least 1000 mg metformin daily. * HBA1C ≥ 8 % and ≤11 %, inclusive, as measured at screening (visit 1). * Patients must have BMI of \> 25 kg/m2 at baseline * Willingness to accept, and demonstrate ability to inject insulin glargine or 75% insulin lispro protamine suspension and 25% insulin lispro injection therapy. * Ability and willingness to perform SMBG profiles using a plasma glucose meter at least twice a day. * Patients must be able to understand and willing to adhere to and be compliant with the study protocol
Exclusion criteria
* Patients, who have had stroke, MI, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months. * Patients with congestive heart failure requiring pharmacological treatment. * Patients on non-selective beta blockers (including ocular). * Patients with impaired renal function, as shown by but not limited to serum creatinine ≥ 1.5 mg/dl (133μmol/L) for males, or ≥ 1.4 mg/dl (124 μmol/L) for females. * Patients with acute infections. * Patients with diagnosis of dementia. * Treatment with systemic steroids or large doses of inhaled steroids. * Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis. * Patients with planned radiological examinations requiring administration of contrasting agents. * Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range. * Patients with history of hypoglycemia unawareness. * Pregnant or lactating females. * Failure to use adequate contraception (women of current reproductive potential only). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in hemoglobin A1c (HbA1c) levels at week 24 | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 7.0% at Week 24 | 24 weeks |
| Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 8.0% at Week 24 | 24 weeks |
| Change from baseline in fasting plasma glucose (FBG) values at week 24 | 24 weeks |
| Change from baseline in serum lipid values at week 24 | 24 weeks |
| Number and severity of hypoglycemic events and time of occurrence of hypoglycemic events | 24 weeks |
Countries
United States
Outcome results
None listed