or one of the excipientsin FIASP® [see Contraindications (4)].
5.7 Fluid Retention and Heart Failure with Concomitant
Use of PPAR-Gamma Agonists
Thiazolidinediones (TZDs), which are peroxisome proliferator-activatedreceptor (PPAR)-gamma agonists, can cause dose-relatedfluid retention, particularly when used in combination with insulin.
Fluid retention may lead to or exacerbate heart failure. Patientstreated with insulin, including FIASP®, and a PPAR-gamma agonistshould be observed for signs and symptoms of heart failure.
Ifheart failure develops, it should be managed according to currentstandards of care, and discontinuation or dose reduction of thePPAR-gamma agonist must be considered.
6 ADVERSE REACTIONS
The following adverse reactions are also discussed elsewhere:
• Hypoglycemia [see Warnings and Precautions (5.3)]
• Hypokalemia [see Warnings and Precautions (5.5)]
• Hypersensitivity and allergic reactions [see Warnings andPrecautions (5.6)]
6.1 Clinical Trial Experience
Because clinical trials are conducted under widely varyingconditions, adverse reaction rates observed in the clinical trialsof a drug cannot be directly compared to rates in the clinical trialsof another drug, and may not reflect the rates actually observed inclinical practice.
The data in Table 1 reflect the exposure of 763 patients with type1 diabetes to FIASP® in one clinical trial with a mean exposureduration of 25 weeks [see Clinical Studies (14)].
The mean agewas 44.4 years and the mean duration of diabetes was 19.9 years.
59% were male, 93% were Caucasian, 2% were Black or AfricanAmerican and 7% were Hispanic. The mean BMI was 26.7 kg/m2 andthe mean HbA1c at baseline was 7.6%.
The data in Table 2 reflect the exposure of 341 patients with type2 diabetes to FIASP® in one clinical trial with a mean exposureduration of 24 weeks [see Clinical Studies (14)].
The mean agewas 59.6 years and the mean duration of diabetes was 13.2 years.
47% were male, 80% were Caucasian, 6% were Black or AfricanAmerican and 8% were Hispanic. The mean BMI was 31.5 kg/m2 andthe mean HbA1c at baseline was 8.0%.
Common adverse reactions, excluding hypoglycemia, were definedas events occurring in ≥5% and occurring at the same rate or greaterfor FIASP®-treated subjects than comparator-treated subjects.
Table 1. Adverse Reactions (%*) in Patients with Type 1
Diabetes
Mealtime FIASP®
+ Insulin detemir
(N=386)
Postmeal FIASP® +
Insulin detemir
(N=377)
Nasopharyngitis 20.2 23.9
Upper respiratory
tract infection 9.1 7.4
Nausea 4.9 5.0
Diarrhea 5.4 3.2
Back pain 5.2 4.0
*Incidence ≥ 5% and occurring at the same rate or greater with
FIASP® than comparator
Table 2. Adverse Reactions (%*) in Patients with Type 2
Diabetes
FIASP® + Insulin glargine
(N=341)
Urinary tract infection 5.9
*Incidence ≥ 5% and occurring at the same rate or greater with
FIASP® than comparator
Hypoglycemia
Hypoglycemia is the most commonly observed adverse reactionin patients using insulin, including FIASP® [see Warnings andPrecautions (5.3)].
The rates of reported hypoglycemia depend onthe definition of hypoglycemia used, diabetes type, insulin dose,intensity of glucose control, background therapies, and otherintrinsic and extrinsic patient factors. For these reasons, comparingrates of hypoglycemia in clinical trials for FIASP® with the incidence
of hypog |
