Now approved:
_Onswik™_

What is Onswik?

When was Onswik approved by the FDA?

How was Onswik studied?

Onswik was studied in 4 QWINT clinical trials in adults with T2D.

QWINT-1 study design^1,2:

• QWINT-1 was a 52-week, randomized, open-label, treat-to-target, active-controlled trial evaluating once-weekly subcutaneous Onswik vs. once-daily subcutaneous insulin glargine U-100 (glargine) in insulin-naive adults with T2D who were inadequately controlled on NIADs with A1C of 7% to 10%.
• Following a 3-week lead-in period, participants were randomized 1:1 to Onswik (N=397) or glargine (N=398), and remained on stable doses of 1 to 3 NIADs (DPP-4is, SGLT2is, metformin, AGIs, GLP-1 RAs, or TZDs).
• Primary Endpoint: Noninferiority of Onswik vs glargine in mean change in A1C from baseline to Week 52.
• Dosing: Onswik was initiated at 100 units once weekly and the dosage was escalated every 4 weeks, as needed, to 150, 250, then 400 units once weekly to achieve a target FBG of 80 to 130 mg/dL. Patients with a dose reduction in response to hypoglycemia were not allowed to re-escalate to higher fixed doses. Patients who were treated with the 400 units per week dosage for at least 4 weeks and needed additional dosage adjustments above 400 units per week underwent subsequent dosage adjustment by 20-40 units per week as needed for glycemic control. Glargine was initiated at 10 units once daily that was subsequently adjusted on a weekly basis by 3 to 6 units to achieve same target FBG target range and in response to hypoglycemia.

QWINT-2 study design^1,3:

• QWINT-2 was a 52-week, randomized, open-label, treat-to-target, active-controlled trial evaluating once-weekly subcutaneous Onswik vs. once-daily subcutaneous insulin degludec U-100 (degludec) in insulin-naive adults with T2D who were inadequately controlled on NIADs with A1C of 7% to 10.5%.
• Following a 3-week lead in period, participants were randomized 1:1 to Onswik (N=466) or degludec (N=462), and remained on stable doses of 1 to 3 NIADs (DPP-4is, SGLT2is, metformin, AGIs, GLP-1 RAs, sulfonylureas, or TZDs).
• Primary Endpoint: Noninferiority of Onswik vs degludec in mean change in A1C from baseline to Week 52.
• Dosing: Onswik was initiated with a one-time starting dose of 300 units in Week 1, followed by 100 units in Week 2, and subsequently adjusted on a weekly basis by 20 to 40 units to achieve an FBG target of 80-120 mg/dL and in response to hypoglycemia. Degludec was initiated at 10 units once daily that was subsequently adjusted on a weekly basis by 3 to 6 units to achieve same target FBG target range and in response to hypoglycemia.

QWINT-3 study design^1,4:

• QWINT-3 was a 78-week, randomized, open-label, treat-to-target, active-controlled trial evaluating once-weekly subcutaneous Onswik vs. once-daily subcutaneous degludec in adults with T2D on once- or twice-daily subcutaneous basal insulin therapy alone or in combination with NIADs with A1C of 6.5% to 10%.
• Following a 3-week lead in period, participants were randomized 2:1 to Onswik (N=655) or degludec (N=331), and remained on stable doses of up to 3 NIADs (DPP-4is, SGLT2is, metformin, AGIs, or GLP-1 RAs).
• Primary Endpoint: Noninferiority of Onswik vs degludec in mean change in A1C from baseline to Week 26.
• Dosing: Onswik was initiated at a one-time starting dose calculated by multiplying the prior total daily basal insulin dose by 7 and then multiplying by 3. For patients with a baseline FBG ≤ 120 mg/dL, a one-time starting dose was not recommended; the initial Onswik dose was the prior total basal insulin dose multiplied by 7. The second weekly dose was the prior total daily basal insulin dose multiplied by 7 that was subsequently adjusted on a weekly basis by 20 to 40 units to achieve a target FBG range of 80 to 120 mg/dL and in response to hypoglycemia. Degludec was initiated at 10 units once daily then was subsequently adjusted on a weekly basis by 2 to 6 units to achieve same target FBG target range and in response to hypoglycemia.

QWINT-4 study design^1,5:

• QWINT-4 was a 26-week, randomized, open label, treat-to target, active-controlled trial evaluating once-weekly subcutaneous Onswik vs. once-daily subcutaneous glargine in adults with T2D who were on once- or twice-daily basal and mealtime insulin or in combination with NIADs with A1C of 7% to 10%.
• Following a 3-week lead in period, participants were randomized 1:1 to Onswik (N=365) or glargine (N=365), and remained on stable doses of up to 3 NIADs (DPP-4is, SGLT2is, metformin, or GLP-1 RAs). Participants also received mealtime insulin lispro.
• Primary Endpoint: Noninferiority of Onswik vs glargine in mean change in A1C change from baseline to Week 26.
• Dosing: Onswik was initiated at a one-time starting dose calculated by multiplying the prior total daily basal insulin dose by 7 and then multiplying by 3. For patients with a baseline FBG ≤120 mg/dL, a one-time starting dose was not recommended; the initial Onswik dose was the prior total daily basal insulin dose multiplied by 7. The second weekly dose was the prior total daily basal insulin dose multiplied by 7 that was subsequently adjusted on a weekly basis by 20 to 40 units to achieve a target FBG range of 80 to 120 mg/dL and in response to hypoglycemia. Glargine was initiated at 10 units once daily that was subsequently adjusted on a weekly basis by 3 to 6 units to achieve same target FBG target range and in response to hypoglycemia.
  
  AGIs=alpha-glucosidase inhibitors; A1C=glycated hemoglobin; CGM=continuous glucose monitoring; DPP-4is=dipeptidyl peptidase-4 inhibitors; FBG=fasting blood glucose; GLP-1 RAs=glucagon-like peptide-1 receptor agonists; NIADs=noninsulin antidiabetic medications; SGLT2is=sodium-glucose co-transporter 2 inhibitors; T2D=type 2 diabetes; TZDs=thiazolidinediones; U-100=100 units/mL

What Onswik KwikPen dosages will be available?

The U-500 KwikPen (500 units/mL) delivers doses in 5-unit increments, can deliver up to 400 units in a single injection, and contains 1,500 units total in presentation.

The U-1,000 KwikPen (1,000 units/mL) delivers doses in 10-unit increments, can deliver up to 800 units in a single injection, and contains 3,000 units total in presentation.

When will Onswik be available in pharmacies?