Clinical trial NCT04287179: SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes
Official title: Effect and Safety of Two Different Dose-escalation Regimens for Once-weekly Semaglutide s.c. in Subjects With Type 2 Diabetes Mellitus Previously Treated With GLP-1 RAs
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-02-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the effect and safety of 2 dose schedules for semaglutide (study medicine) in people with type 2 diabetes previously treated with a diabetes medicine similar to semaglutide. The study will also evaluate the use of a new pen-injector for semaglutide used to inject medicine under the skin, at a new dose of 2 mg. People taking part in the study will take this medicine together with their current diabetes tablets other than semaglutide. Participants will either get a start dose of 0.25 mg semaglutide or 0.50 mg semaglutide, and the dose will be gradually increased to 2.0 mg semaglutide - which treatment is decided by chance. Participants will inject semaglutide under the skin once a week, any time of the day. When the dose reaches 2.0 mg semaglutide, participants will inject the medicine with a new type of pen-injector. The study will last for about 24 weeks. Participants will have 9 visits and 1 phone call with the study doctor. At 9 visits participants will have blood taken and at 2 visits they will have eye examination done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Women who are able to get pregnant will be checked 10 times for pregnancy via urine tests.


Eligibility criteria: Inclusion Criteria:

* Male or female, age 18 years or older at the time of signing informed consent.
* Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.
* The need and willingness to change prior GLP-1 RA treatment to once-weekly semaglutide s.c., as assessed by the investigator.
* HbA1c of 6.5-10% (48-86 mmol/mol) (both inclusive).
* Treatment with any therapeutic dose of GLP-1 RA other than once-weekly semaglutide s.c., as defined in the local label, with or without OADs (metformin, DPP-4 inhibitor, SU, glinide, thiazolidinedione, SGLT-2 inhibitor or alpha-glucosidase inhibitor). All doses of antidiabetic treatments should have been stable for at least 90 days prior to the day of the screening, at investigator's discretion.

Exclusion Criteria:

* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
* Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m2 according to Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) creatinine equation as defined by KDIGO 2012 classification.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Primary outcomes:
measure: Change in glycosylated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to week 12
Secondary outcomes:
measure: Change in fasting plasma glucose
timeFrame: From baseline (week 0) to week 12
measure: Change in body weight
timeFrame: From baseline (week 0) to week 12
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From baseline (week 0) to week 12
measure: Number of treatment emergent gastrointestinal adverse events
timeFrame: From baseline (week 0) to week 12
measure: Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes
timeFrame: From baseline (week 0) to week 12
measure: Change in pulse rate
timeFrame: From baseline (week 0) to week 12
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From week 12 to week 17
Other outcomes:
Locations:
city: Buena Park
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Fresno
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Jose
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Waterbury
country: United States
facility: Novo Nordisk Investigational Site
state: Connecticut
city: Honolulu
country: United States
facility: Novo Nordisk Investigational Site
state: Hawaii
city: Idaho Falls
country: United States
facility: Novo Nordisk Investigational Site
state: Idaho
city: Indianapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Troy
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Albany
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: West Seneca
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Round Rock
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
city: Stockerau
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Jyväskylä
country: Finland
facility: Novo Nordisk Investigational Site
city: Kuopio
country: Finland
facility: Novo Nordisk Investigational Site
city: Lahti
country: Finland
facility: Novo Nordisk Investigational Site
city: Raisio
country: Finland
facility: Novo Nordisk Investigational Site
city: Seinäjoki
country: Finland
facility: Novo Nordisk Investigational Site
city: Göteborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor & Disclosure (1452)
role: STUDY_DIRECTOR
References: