Comparison of the Efficacy and Safety of Two Insulin Intensification Strategies

Lilly

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Prandial Insulin Lispro; Drug: Insulin Lispro Low Mixture (LM); Drug: Insulin Glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01175824

F3Z-CR-IOQE (Other Identifier)

13493

Details and patient eligibility

About

The study is a comparison of twice-daily insulin lispro low mixture versus once-daily basal insulin glargine and once-daily prandial insulin lispro, in participants with Type 2 Diabetes.

Enrollment: 478 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Present with type 2 diabetes mellitus
• Have been taking metformin and/or pioglitazone
• Have received treatment with basal insulin glargine, injected once a day, for greater than or equal to 90 days
• Have glycosylated hemoglobin A1c (HbA1c) concentration between greater than or equal to 7.5% and less than or equal to 10.5
• Have a fasting plasma glucose concentration of less than or equal to 6.7 millimoles per liter [mmol/L, less than or equal to 121 milligrams per deciliter (mg/dL)], or greater than 6.7 mmol/L (greater than 121 mg/dL) if the investigator considers that further titration of basal insulin glargine is not possible for safety reasons
• Not pregnant or breastfeeding

Exclusion criteria

• Have Type 1 Diabetes
• Their stable dose of pioglitazone is greater than the maximum dose approved for use in combination with insulin in their country
• Have a body mass index (BMI) greater than 45 kilograms per square meter (kg/m2).
• Have a history of scheduled mealtime (prandial) insulin use within 12 weeks of the screening visit and the total duration of the prandial insulin treatment was greater than 2 weeks
• Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study
• Have cardiac disease with a functional status that is Class III or IV
• Have a history of renal or liver disease
• Have had a blood transfusion or have a blood disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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478 participants in 2 patient groups

Insulin lispro low mixture (LM)

Experimental group

Description:

Two daily injections (breakfast and dinner) of insulin lispro mix 75/25

Treatment:

Drug: Insulin Lispro Low Mixture (LM)

Insulin glargine+insulin lispro

Active Comparator group

Description:

Once-daily (bedtime) basal insulin glargine and once-daily (before the main meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro

Treatment:

Drug: Insulin Glargine

Drug: Prandial Insulin Lispro