Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates.
OBJECTIVE
Patients with type 2 diabetes mellitus (T2DM) have increased risk of adverse events (AEs; e.g. dehydration, hypoglycaemia) in hot weather. This analysis assessed the efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, in patients with T2DM who live in hot climates.


METHODS
This post hoc analysis evaluated patients with T2DM using pooled data from four 26-week, placebo-controlled studies (N=2,313) and data from a 104-week, active-controlled study (add-on to metformin vs glimepiride; N=1,450). Changes in HbA1c, fasting plasma glucose (FPG), body weight and blood pressure (BP) were assessed in subsets of patients living in hot climates (pooled, placebo-controlled studies, n=611; active-controlled study, n=307) and those living in other climates (i.e. other climate subset; pooled, placebo-controlled studies, n=1,702; active-controlled study, n=1,143). Safety was assessed based on AE reports.


RESULTS
Canagliflozin 100 and 300 mg lowered HbA1c, FPG, body weight and BP vs placebo over 26 weeks and glimepiride over 104 weeks in the hot climate subsets. Canagliflozin was generally well tolerated in the hot climate subsets, with a higher incidence of AEs related to the mechanism of SGLT2 inhibition (i.e. genital mycotic infections). Volume depletion-related AEs were low across groups.


CONCLUSIONS
Canagliflozin improved glycaemic control, lowered body weight and BP, and was generally well tolerated in patients with T2DM living in hot climates compared with placebo over 26 weeks or glimepiride over 104 weeks.


BACKGROUND
ClinicalTrials.gov NCT01081834, NCT01106677, NCT01106625, NCT01106690, NCT00968812.
Providence Endocrine & Diabetes Specialty Centre, Trivandrum, Kerala, India. drmathewjohn@yahoo.com.
Mathew
M
John
Hospital Cima, Centro de Investigacíon Clínica San Agustín, San José, Costa Rica.
Sonia
S
Cerdas
Centro de Estudios de Investigacíon Metabólicos y Cardiovasculares S.C., Tampico, Mexico.
Rafael
R
Violante
Rajavithi Hospital, Rangsit Medical School, Bangkok, Thailand.
Chaicharn
C
Deerochanawong
Dubai Hospital, Dubai Health Authority, Dubai, United Arab Emirates.
Mohamed
M
Hassanein
Axio Research, Seattle, WA, USA.
April
A
Slee
Janssen Global Services, LLC, Raritan, NJ, USA.
William
W
Canovatchel
Janssen-Cilag Ltd, High Wycombe, UK.
Gill
G
Hamilton
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001794:Blood Pressure / Q000187:drug effects; D000068896:Canagliflozin / Q000008:administration & dosage* / Q000009:adverse effects; D048909:Diabetes Complications / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005831:Genital Diseases, Female / Q000139:chemically induced; D005832:Genital Diseases, Male / Q000139:chemically induced; D006442:Glycated Hemoglobin / Q000378:metabolism; D006358:Hot Temperature; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000139:chemically induced; D012111:Residence Characteristics; D016896:Treatment Outcome; D014555:Urination Disorders / Q000139:chemically induced; D015431:Weight Loss / Q000187:drug effects; D055815:Young Adult
D000068896:Canagliflozin; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents