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
Overview
- Phase
- Phase 4
- Intervention
- Insulin Lispro Premix
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Eli Lilly and Company
- Enrollment
- 402
- Locations
- 1
- Primary Endpoint
- Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of the study is to compare the effects on overall glycaemic control of two insulin intensification therapies.
Investigators
Eligibility 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).
Arms & Interventions
Premixed Insulin
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 \[LM25\])
Intervention: Insulin Lispro Premix
Basal-Bolus
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro
Intervention: Insulin Glargine
Basal-Bolus
Once daily (bedtime) insulin glargine and three pre-meal insulin lispro
Intervention: Insulin Lispro
Outcomes
Primary Outcomes
Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint
Time Frame: Baseline, 24 weeks
Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.
Secondary Outcomes
- Daily Dose of Insulin: Total, Basal, and Prandial(24 weeks)
- The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.(Baseline, 12 weeks, and 24 weeks)
- Percentage of Participants Experiencing a Severe Hypoglycemic Episode(baseline through 24 weeks)
- Change in HbA1c From Baseline to 12 Week Endpoint(Baseline, 12 weeks)
- The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks(12 weeks, 24 weeks)
- Daily Dose of Insulin Per Kilogram of Body Weight: Total, Basal and Prandial(24 weeks)
- Percentage of Participants With Hypoglycemic Episodes (Incidence)(baseline through 24 weeks)
- Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks(Baseline, 12 weeks, and 24 weeks)
- The Rate of Hypoglycemic Episodes(baseline through 24 weeks)