A Study Comparing Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus

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

Summary

The purpose of the study is to compare the effects on overall glycaemic control of two insulin intensification therapies.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Biphasic Insulins; Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, insulin lispro drug combination 50:50

Criteria

Inclusion Criteria:

• Present with type 2 diabetes mellitus

• Have been receiving twice-daily premixed insulin therapy with or without metformin and/or alpha-glucosidase inhibitors, for at least six months prior to study entry

• Have Haemoglobin A1c (HbA1c) >7.0% and <12.0%

Exclusion Criteria:

• Within the last 3 months prior to entry into the study, are taking any non-permitted glucose-lowering agents, or are taking any non-permitted oral antihyperglycaemic medications

• Are pregnant or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.

• Are women who are breastfeeding.

• Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night).

• Do not regularly consume three meals per day.

• Have a body mass index >35 kilogram per square meter (kg/m^2).

• 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 used less than or equal to 20 Units per day (U/day) of insulin during the past 90 days for more than 14 days (accumulated).