At a glance
ClinicalIndex Comparison Record- ✓Type 2 diabetes mellitus
- ✓Age 30 to <80 years
- ✓On at least 2 oral antidiabetic agents for ≥90 days
- ✓HbA1c 1.2–2.0 times the upper limit of normal at local lab
- ✕No regular insulin use in past 12 months
- ✕No more than 1 episode of severe hypoglycemia in past 24 weeks
- ✕BMI ≤45
- ✕No clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Durability of Twice-Daily Insulin Lispro Low Mixture Compared to Once-Daily Insulin Glargine When Added to Existing Oral Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control
In Brief
A Phase 4 clinical trial evaluating Insulin glargine, Lispro Low Mix, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 2,091 participants across 199 sites in 12 countries.
Detailed Summary
This study will compare insulin lispro low mixture \[LM\] and insulin glargine both in combination with the patient's oral diabetes medicines, for their ability to control blood sugar in patients with type 2 diabetes and compare insulin lispro LM to insulin glargine with regard to the length of time that the overall blood sugar can be controlled. This study will also determine whether the safety of insulin lispro LM and any side effects that might be associated with it are different from those observed with insulin glargine, both in combination with the patient's oral diabetes medications. The addendum study (Intensification Addendum) will compare how different insulin treatments work to control blood sugar in patients whose diabetes could not be controlled by either insulin lispro LM or insulin glargine.
Study Details
Timeline
Interventions
Subcutaneous injection daily
Subcutaneous injection twice daily.
Lispro Mid Mix subcutaneous injection 3 times daily.
Lispro subcutaneous injection 3 times daily.