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

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

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%

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; Metformin; Protamines

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.