Patient population was considered to be at increased risk for hypoglycemia
In the SWITCH 2 trial in patients with T2D at increased risk of hypoglycemia
In a separate study designed to further evaluate the safety profile, hypoglycemia rates of Tresiba® U-100 were compared to insulin glargine U-1001
Primary endpoint: Rate of severea or BG-confirmedb symptomatic hypoglycemia events in adult patients with type 2 diabetes in the maintenance period
Tresiba® U-100
185.6 events
per 100 patient-years1,c
22.5%
of patients experienced severe or BG-confirmed symptomatic hypoglycemia1,a,b
Insulin glargine U-100
Insulin glargine U-100
265.4 events
per 100 patient-years1,c
31.6%
of patients experienced severe or BG-confirmed symptomatic hypoglycemia1,a,b,c
Insulin glargine
U-100
Insulin glargine U-100
265.4 events
per 100 patient-years1,c
31.6%
of patients experienced severe or BG-confirmed symptomatic hypoglycemia1,a,b,c
Achieved with similar glycemic control: Tresiba® U-100 vs insulin glargine U-100
- In the separate, type 2 diabetes adult trials within the BEGIN clinical trial program, the percentage of patients experiencing at least 1 episode ranged from 0% to 4.5% for severe hypoglycemia and 28.5% to 80.9% for Novo Nordisk-defined hypoglycemia in trials with Tresiba® U-100 ± OADs or in a basal bolus regimen2,a,d
- The American Diabetes Association classifies hypoglycemia <54 mg/dL as clinically significant and sufficiently low to indicate serious, clinically important hypoglycemia3
aSevere hypoglycemia: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.2
bBG-confirmed symptomatic hypoglycemia was defined as a BG measurement of <56 mg/dL with symptoms; nocturnal hypoglycemia was defined as any episode occurring between 12:01 AM and 5:59 AM, both inclusive; and severe hypoglycemia was defined per American Diabetes Association 2013 guidelines.
cDifference in percentage: –9.1% [95% CI: –13.1% to –5.0%].
dNovo Nordisk-defined hypoglycemia: a severe hypoglycemia event or an event where laboratory or self-measured glucose calibrated to plasma was <56 mg/dL or where whole blood glucose was <50 mg/dL (ie, with or without the presence of hypoglycemic symptoms).2
SWITCH 2 study design1
Hypoglycemia rates of Tresiba® U-100 and insulin glargine U-100 were compared in a randomized, double-blind, crossover study1
20% dose reduction
from twice-daily dosing. If switching from once-daily dosing, the starting dose was the pretrial dose.e
721 adult patients
with type 2 diabetes taking basal insulin ± OADs.
- Patient population was considered to be at increased risk for hypoglycemia.
Hypoglycemia may be happening more often than you think
Treatment arm 1
Treatment arm 2
A1C noninferiority in both treatment periods was a prerequisite1
- Primary endpoint achieved: Tresiba® U-100 demonstrated superiority vs insulin glargine U-100 in terms of rates of severe or BG-confirmed symptomatic hypoglycemica,b episodes during the maintenance period of each treatment period
- This study design ensured that all patients were exposed to each trial medication for the same amount of time
- Mean A1C at the end of treatment period 1: Tresiba® U-100, 7.06%; insulin glargine U-100, 6.98%1
- Mean A1C at the end of treatment period 2: Tresiba® U-100, 7.08%; insulin glargine U-100, 7.11%1
All patients required to meet ≥1 of these criteria for developing hypoglycemia:
- ≥1 episode of severe hypoglycemiaf in previous year
- Moderate chronic renal failure (eGFR: 30 to 59 mL/min/1.73 m2)
- Hypoglycemic symptom unawareness
- Insulin exposure >5 years
- Episode of hypoglycemiag within previous 12 weeks
eThe starting dose for treatment period 2 was the dose from the end of treatment period 1.
fBased on ADA definition.
gSymptoms and/or BG level ≤70 mg/dL.
Secondary endpoints achieved1
Secondary confirmatory endpoints
- The rate of nocturnal symptomatic hypoglycemiah during the maintenance period was 42% lower with Tresiba® U-100 vs insulin glargine U-100 (55.2 vs 93.6 episodes/100 PYE, respectively; ERR=0.58 [95% CI, 0.46 to 0.74]; P<0.001; rate difference, –7.41 episodes/100 PYE [95% CI, –11.98 to –2.85])
- The rate of severe hypoglycemiaa during the maintenance period was 46% lower with Tresiba® U-100 vs insulin glargine U-100 (5.3 vs 9.1 episodes/100 PYE, respectively; ERR=0.54 [95% CI, 0.21 to 1.42]; P=not significant; rate difference, –1.18 episodes/100 PYE [95% CI, –2.77 to –0.41])
- The percentage of patients experiencing at least 1 episode of severe hypoglycemia in the maintenance period was: Tresiba® U-100 1.6%; insulin glargine U-100 2.4% (P=not significant)
Achieved with similar glycemic control: Tresiba® U-100 vs insulin glargine U-100
hNocturnal hypoglycemia was defined as any episode occurring between 12:01 AM and 5:59 AM, both inclusive; and severe hypoglycemia was defined per American Diabetes Association 2013 guidelines.
BG=blood glucose; OADs=oral antidiabetic drugs.
