Lantus Versus Humalog Mix as add-on Therapy in Type Diabetes Patients Failing Sulfonylurea and Metformin Combination Treatment

Lantus® (Insulin Glargine[rDNA Origin] Injection) vs Humalog® Mix 75/25 (75% Insulin Lispro Protamine Suspension and 25% Insulin Lispro Injection) as add-on Therapy in Type 2 Diabetes Patients Failing Sulfonylurea and Glucophage (Metformin) Combination Treatment: a Randomized, Open, Parallel Study

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%

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.

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.