Comparison of the Efficacy and Safety of Two Insulin Intensification Strategies

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; Protamines

Criteria

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