At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Comparison of Insulin Lispro MM Intensive Mixture Therapy With Progressive Dose-Titration of Insulin Lispro LM or Biphasic Insulin Aspart 30/70
In Brief
A Phase 4 clinical trial evaluating Insulin Biphasic Aspart 30/70, insulin lispro LM, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 302 participants across 9 sites in 5 countries.
Detailed Summary
Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic control while treated with combination of premixed insulin analogue formulations twice daily and metformin will be randomly assigned to follow one of two insulin treatment strategies used in combination with metformin administration. The aim of the trial is to try to achieve optimal metabolic control and explore full therapeutic potential of the strategies, patients in both arms will follow progressive insulin dose titration algorithms for 16 weeks.
Study Details
Timeline
Interventions
Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks
Participant adjusted dose, injected subcutaneously for 16 weeks - possibility of using instead of insulin lispro MM before evening meal if there is a risk of hypoglycemia after the dinner or high fasting glucose levels.
Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks
Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks