Technosphere Insulin (TI), an inhaled insulin with ultra-rapid onset and short duration of action, may improve patient outcomes. This study aimed to determine real-world dosing requirements, safety, and efficacy of TI use in patients with uncontrolled type 2 diabetes (T2D).
Twenty patients with T2D inadequately controlled with oral/injectable combination therapy in a real-world setting received TI added to current therapy. Dosing started at TI 4 U and was adjusted weekly on the basis of postprandial glucose levels. HbA1c and CGM profiles were collected at baseline and 12 weeks.
Final mealtime doses were 18, 17, and 19 U for breakfast, lunch, and dinner, respectively. Mealtime TI resulted in significant reductions from baseline at week 12 in HbA1c (-1.6%, P<0.0001; Table) and mean daily glucose (-41.0 mg/dL, P<0.0002) and increased time in range (TIR) by 23.5%, with a 1.5% increase in hypoglycemia and no severe hypoglycemia (Table). Patients averaging ≥20 U per meal had a 92% increase in TIR , with no substantial increase in hypoglycemia (1.9%). Weight loss of 0.91 kg occurred (not significant).
Table. | |||
Primary endpoint (SD), % | Baseline (N=20) | Week 12 (N=20) | Change |
Mean HbA1c | 9.0 (1.0) | 7.4 (0.6) | -1.6 P<0.0001 |
CGM data | |||
Time in range | 42.2 (22.2) | 65.7 (16.2) | +23.5 (22.6) P<0.0002 |
Time <70 mg/dL | 1.1 (2.3) | 2.6 (2.5) | +1.5 (1.3) P<0.01 |
Time >180 mg/dL | 57.3 (23.3) | 32.5 (16.9) | -24.8 (23.1) P<0.0002 |
CGM, continuous glucose monitoring; HbA1c, glycated hemoglobin. |
Addition of mealtime TI significantly improved overall glycemic control in patients previously uncontrolled with oral/injectable diabetes medications.