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

A Comparison of Premixed and Basal-Bolus Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Twice-daily Premixed Insulin

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

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).