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

Launched by SANOFI · Apr 15, 2011

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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.