Comparison of Premixed Insulin Lispro Low Mixture and Mid Mixture Regimens with Separate Basal and Bolus Insulin Injections in Patients with Type 2 Diabetes with Inadequate Glycemic Control on Oral Therapy who Consume Light Breakfast

Woman and Man

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Extract

The primary objective of this study is to test the hypothesis that glycemic control achieved when initiating insulin treatment with insulin lispro mid mix /low mix as a single daily injection either before midday or evening meal, and progressing up to three daily injections of mid mix/low mix is noninferior to that achieved when initiating insulin glargine as a single daily injection and progressing to up to three additional daily injections of meal-time insulin lispro. Glycemic control will be determined by measuring the mean change from baseline to endpoint of hemoglobin A1c (HbA1c) after approximately 48 weeks, in patients with type 2 diabetes mellitus who have a habit of consuming less than 15% of their daily caloric intake at morning meal and who have inadequate glycemic control (HbA1c ≥7%) on oral antihyperglycemic medication(s). A noninferiority margin of 0.4% for HbA1c will be used.

Inclusion criteria

Type 2 diabetes mellitus

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Comparison of Premixed Insulin Lispro Low Mixture and Mid Mixture Regimens with Separate Basal and Bolus Insulin Injections in Patients with Type 2 Diabetes with Inadequate Glycemic Control on Oral Th...