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

Lilly

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin Glargine; Drug: Insulin Lispro Premix; Drug: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT01175811

F3Z-CR-IOQD (Other Identifier)

13492

Details and patient eligibility

About

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

Enrollment: 402 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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402 participants in 2 patient groups

Premixed Insulin

Experimental group

Description:

Twice daily (before breakfast and lunch) insulin lispro mix 50 (50% insulin lispro, 50% insulin lispro protamine suspension \[LM50\]) and once daily (before dinner) insulin lispro mix 25 (25% insulin lispro, 75% insulin lispro protamine suspension \[LM25\])

Treatment:

Drug: Insulin Lispro Premix

Basal-Bolus

Active Comparator group

Description:

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro

Treatment:

Drug: Insulin Lispro

Drug: Insulin Glargine