This trial is conducted in Asia. The aim of the trial is to investigate safety and efficacy of semaglutide once weekly in monotherapy or in combination with one OAD (oral anti-diabetic drug) in Japanese subjects with type 2 diabetes who are insufficiently controlled on diet/exercise therapy or OAD monotherapy. All subjects will continue their pre-trial treatment (diet and exercise therapy or OAD monotherapy in addition to diet and exercise therapy) during the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
601
Subject will receive either a dose of 0.5 or 1.0 mg of semaglutide once weekly (subcutaneous (s.c.) injection).Treatment duration 56 weeks.
Subjects will receive one DPP-4 inhibitor in addition to pre-trial OAD monotherapy, if any, for 56 weeks.
Novo Nordisk Investigational Site
Akita-shi, Akita, Japan
Novo Nordisk Investigational Site
Annaka-shi, Gunma, Japan
Novo Nordisk Investigational Site
Asahikawa-shi, Hokkaido, Japan
Novo Nordisk Investigational Site
Asahikawa-shi, Hokkaido, Japan
Novo Nordisk Investigational Site
Bunkyo-ku, Tokyo, Japan
Number of Treatment Emergent Adverse Events (TEAEs)
An adverse event (AEs) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).
Time frame: Weeks 0-56
Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of \<56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia: was an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The episodes mentioned here are treatment emergent hypoglycaemic episodes and defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).
Time frame: Weeks 0-56
Change in Glycosylated Haemoglobin A1c (HbA1c)
The observed mean change in HbA1c values from baseline after 56 weeks of treatment. Changes in HbA1c were analysed using a mixed model for repeated measurements (MMRM) with treatment and pre-trial treatment at screening as fixed factors and baseline value as covariate. The data were analysed for the "on-treatment without rescue medication" observation period which includes observations noted at or after the date of first dose of randomised treatment and not after the last dose of the trial product (+ a 7-day visit window) or initiation of rescue medication.
Time frame: Week 0, week 56
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Novo Nordisk Investigational Site
Chuo-ku Tokyo, Japan
Novo Nordisk Investigational Site
Chuo-ku Tokyo, Japan
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan
Novo Nordisk Investigational Site
Chuo-ku, Tokyo, Japan
...and 33 more locations