Comparison of Twice-Daily Insulin Lispro Low Mixture Versus Once-Daily Basal Insulin Glargine and Once-Daily Prandial Insulin Lispro as Insulin Intensification Strategies in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine and Metformin and/or Pioglitazone

Eli Lilly and Company0 个研究点目标入组 478 人开始时间: 待定最近更新: 2021年11月24日

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•Present with type 2 diabetes mellitus
•-Have been taking metformin and/or pioglitazone
•-Have received treatment with basal insulin glargine, injected once a day, for greater than or equal to 90 days
•-Have HbA1c concentration between greater than or equal to 7.5% and less than or equal to 10.5
•-Have a fasting plasma glucose concentration of less than or equal to 6.7 mmol/L (less than or equal to 121 mg/dL), or greater than 6.7 mmol/L (greater than 121 mg/dL) if the investigator considers that further titration of basal insulin glargine is not possible for safety reasons
•-Not pregnant or breastfeeding

•-Have Type 1 Diabetes
•-Their stable dose of pioglitazone is greater than the maximum dose approved for use in combination with insulin in their country
•-Have a body mass index (BMI) greater than 45 kg/m2.
•-Have a history of scheduled mealtime (prandial) insulin use within 12 weeks of the screening visit and the total duration of the prandial insulin treatment was greater than 2 weeks
•-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 had a blood transfusion or have a blood disorder

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