Table 2: Adverse Reactions Occurring in ≥5% of TRESIBA-Treated Patients with Type 2 Diabetes Mellitus

Adverse Reaction
 TRESIBA

(n=2713)
 
Nasopharyngitis
 12.9 %
 
Headache
 8.8 %
 
Upper respiratory tract infection
 8.4 %
 
Diarrhea
 6.3 %
 
Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including TRESIBA [see Warnings and Precautions (5.3)]. The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for TRESIBA with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that will occur in clinical practice.

The percent of participants randomized to TRESIBA who experienced at least one episode of hypoglycemia in adult clinical trials [see Clinical Studies (14)] of patients with type 1 and type 2 diabetes respectively, are shown in Table 3 and 4. No clinically important differences in risk of hypoglycemia between TRESIBA and comparators was observed in clinical trials.

Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. A Novo Nordisk hypoglycemia episode was defined as a severe hypoglycemia episode or an episode where a laboratory or a self-measured glucose calibrated to plasma was less than 56 mg/dL or where a whole blood glucose was less than 50 mg/dL (i.e., with or without the presence of hypoglycemic symptoms).

Table 3: Percent (%) of Type 1 Diabetes Patients Experiencing at Least One Episode of Severe Hypoglycemia or Novo Nordisk Hypoglycemia§ on TRESIBA in Adult Clinical Trials

 Study A
+ insulin aspart
52 weeks Study B
+ insulin aspart
26 weeks Study C
+ insulin aspart
26 weeks
 TRESIBA
(N=472) TRESIBA
(N=301) TRESIBA at the same time each day
(N=165) TRESIBA at alternating times
(N=164)
Severe hypoglycemia
 
Percent of patients
 12.3%
 10.6%
 12.7%
 10.4%
 
Novo Nordisk hypoglycemia§
 
Percent of patients
 95.6%
 93.0%
 99.4%
 93.9%
 
§Novo Nordisk hypoglycemia: a severe hypoglycemia episode or an episode where a laboratory or a self-measured glucose calibrated to plasma was less than 56 mg/dL or where a whole blood glucose was less than 50 mg/dL (i.e., with or without the presence of hypoglycemic symptoms).

Table 4: Percent (%) of Patients with Type 2 Diabetes Experiencing at Least One Episode of Severe Hypoglycemia or Novo Nordisk Hypoglycemia§ on TRESIBA in Adult Clinical Trials

 Study D
+ 1-2 OADs*
insulin naïve
52 weeks Study E
+ 1-2 OAD*s
insulin naïve
26 weeks Study F
± 1-3 OADs*
insulin naïve
26 weeks Study G
T2DM ± 0-3 OADs*
26 weeks Study H
T2DM ± 0-2
OADs* +
insulin aspart
26 weeks Study I
T2DM ± 1-2
OADs*
insulin naïve
26 weeks
 TRESIBA
(N=766) T