Insulin Glargine "All to Target" Trial

Summary

The primary objectives were: * To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c \[HbA1c\] \<7.0%) at Week 60 * To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from Baseline to Week 60 in HbA1c

Timeline

Start

2006-05

Primary completion

2010-03

Completion

2010-03

Outcome

Mixed primary results

registry Lantus/Apidra-3 vs Novolog Mix 70/30; p = 0.0628; Adjusted Odds Ratio 1.56 (95% CI 0.97 to 2.52); NCT00384085 ↗

registry NUMBER Lantus/Apidra-3: HbA1c < 7.0%: 44.1 percentage of participants NCT00384085 ↗

registry Lantus/Apidra-3 vs Novolog Mix 70/30; p = 0.0313; Adjusted Odds Ratio 1.66 (95% CI 1.04 to 2.64); NCT00384085 ↗

registry The type I error was controlled by performing a 2-tailed comparison at a p=0.0475 level for superiority testing. NCT00384085 ↗

Publications

• Polonsky WH, Thompson S, Wei W, Riddle MC, Chaudhari S, Jackson J, Bruno AS. Greater fear of hypoglycaemia with premixed insulin than with basal-bolus insulin glargine and glulisine: patient-reported outcomes from a 60-week randomised study. Diabetes Obes Metab. 2014 Nov;16(11):1121-7. doi: 10.1111/dom.12328. Epub 2014 Jul 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Insulin glulisine	Protein / enzyme biologic	—	Subcutaneous
Subject	Novolog® Mix 70/30	Unknown	—	Subcutaneous
Subject	insulin glargine	Protein / enzyme biologic	—	Subcutaneous

Indications