A Study for Type 2 Diabetic Patients

Lilly

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Insulin lispro low mixture; Drug: Insulin glargine; Drug: Insulin lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT00548808

11541 (Registry Identifier)

F3Z-CR-IOPH (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections) on lowering the blood sugar level

Enrollment: 426 patients

Sex: All

Ages: 30 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus
• Receiving oral antihyperglycemic medications (including metformin) without insulin injection in the last 90 days
• Hemoglobin A1c (HbA1c) equal to or greater than 7.0% but less than 11.0%
• Willing to receive insulin injection while continuing to take the prestudy oral antihyperglycemic medications
• Able to perform self monitoring of blood glucose

Exclusion criteria

• Are taking any other glucose-lowering agents other than metformin, sulfonylurea or Thiazolidinedione (Pioglitazone)
• Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks, or for a total of 30 days or more, in the last 24 weeks
• Have a body mass index greater than 35 kg/m2
• History or presence of kidney disease
• Have cardiac disease (Class III or IV)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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426 participants in 2 patient groups

Insulin lispro low mixture

Experimental group

Description:

Insulin lispro low mixture (1, 2 or 3 daily injections)

Treatment:

Drug: Insulin lispro low mixture

Insulin glargine

Active Comparator group

Description:

Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

Treatment:

Drug: Insulin lispro

Drug: Insulin glargine