Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast

Lilly

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin Lispro Premix (mid-mixture and low-mixture); Drug: Insulin Glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00664534

CTRI/2009/091/000609 (Registry Identifier)

11806

F3Z-EW-S020 (Other Identifier)

Details and patient eligibility

About

This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.

Enrollment: 344 patients

Sex: All

Ages: 30 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes Mellitus, Type 2
• have been receiving metformin plus at least one other oral antihyperglycemic medication (OAM) (sulfonylurea or Thiazolidinedione [TZD]) without insulin, for at least 90 days prior to Visit 1
• glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than 11.0%
• regularly consume a light breakfast (less than 15% of total daily calorie intake)
• capable and willing to follow the protocol
• give written consent

Exclusion criteria

• are taking a TZD whose country label does not allow in combination with insulin
• are taking any glucose-lowering agents (other than specified in the inclusion criteria above)
• have a body mass index greater than 40 kg/m^2
• have a history of severe hypoglycemia in past 24 weeks
• 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 study medications
• have an irregular sleep/wake cycle

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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344 participants in 2 patient groups

Glargine

Active Comparator group

Description:

Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs)

Treatment:

Drug: Insulin Glargine

Premixed Insulin Lispro

Experimental group

Description:

Premixed Insulin Lispro (mid-mixture or low-mixture) 1,2 or 3 injections plus OAMs

Treatment:

Drug: Insulin Lispro Premix (mid-mixture and low-mixture)