A Comparison Study of Basal Bolus Therapies Together With Lispro Insulin in Type 2 Diabetes Patients

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin Lispro; Drug: Insulin Glargine; Drug: Insulin Lispro Protamine Suspension (ILPS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00666718

12047

F3Z-EW-IOPJ (Other Identifier)

Details and patient eligibility

About

This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).

Enrollment: 374 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes Mellitus, Type 2
• Have been receiving metformin and at least one other oral antihyperglycemic medication (sulfonylurea or thiazolidinedione) with insulin for at least 3 months prior to Visit 1 (Screening)
• Hemoglobin A1C (HbA1c) greater than or equal to 7.5% and less than or equal to 11.0%
• Body Mass Index (BMI) greater than or equal to 25 and less than or equal to 45 kg/m^2
• Capable and willing to follow the protocol
• Give written consent

Exclusion criteria

• Are taking any glucose-lowering agents (other than those listed in the inclusion criteria above)
• Have a history of severe hypoglycemia in the past 6 months
• Are pregnant or may become pregnant
• Women who are breastfeeding
• Have significant cardiac disease
• Have significant renal or liver disease
• Undergoing therapy for a malignancy
• Contraindications to the study medications
• Have an irregular sleep/wake cycle
• Have a serious disease or any condition considered by the investigator to be exclusionary

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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374 participants in 2 patient groups

Glargine

Active Comparator group

Description:

Glargine plus Insulin Lispro (2-3 injections)

Treatment:

Drug: Insulin Lispro

Drug: Insulin Glargine

ILPS

Experimental group

Description:

Insulin Lispro Protamine Suspension (ILPS) plus Insulin Lispro (2-3 injections)

Treatment:

Drug: Insulin Lispro

Drug: Insulin Lispro Protamine Suspension (ILPS)