SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— SUSTAIN SWITCH  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04287179
• Other study ID #: NN9535-4650
• Secondary ID: U1111-1242-54262
• Status: Withdrawn
• Phase: Phase 3
• Start date: March 9, 2020
• Est. completion date: January 25, 2021

Study information

• Verified date: February 2022
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 25, 2021
• Est. primary completion date: November 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Semaglutide
Dose gradually increased over 12 weeks to 2.0 mg, followed by a 5 week maintenance period.

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Graz
Austria	Novo Nordisk Investigational Site	Stockerau
Austria	Novo Nordisk Investigational Site	Wien
Austria	Novo Nordisk Investigational Site	Wien
Finland	Novo Nordisk Investigational Site	Jyväskylä
Finland	Novo Nordisk Investigational Site	Kuopio
Finland	Novo Nordisk Investigational Site	Lahti
Finland	Novo Nordisk Investigational Site	Raisio
Finland	Novo Nordisk Investigational Site	Seinäjoki
Sweden	Novo Nordisk Investigational Site	Göteborg
Sweden	Novo Nordisk Investigational Site	Malmö
United States	Novo Nordisk Investigational Site	Albany	New York
United States	Novo Nordisk Investigational Site	Buena Park	California
United States	Novo Nordisk Investigational Site	Dallas	Texas
United States	Novo Nordisk Investigational Site	Fresno	California
United States	Novo Nordisk Investigational Site	Honolulu	Hawaii
United States	Novo Nordisk Investigational Site	Idaho Falls	Idaho
United States	Novo Nordisk Investigational Site	Indianapolis	Indiana
United States	Novo Nordisk Investigational Site	Round Rock	Texas
United States	Novo Nordisk Investigational Site	San Jose	California
United States	Novo Nordisk Investigational Site	Sugar Land	Texas
United States	Novo Nordisk Investigational Site	Troy	Michigan
United States	Novo Nordisk Investigational Site	Walnut Creek	California
United States	Novo Nordisk Investigational Site	Waterbury	Connecticut
United States	Novo Nordisk Investigational Site	West Seneca	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Austria,  Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycosylated haemoglobin (HbA1c)	Percent-point	From baseline (week 0) to week 12
Secondary	Change in fasting plasma glucose	mmol/L	From baseline (week 0) to week 12
Secondary	Change in body weight	Kg	From baseline (week 0) to week 12
Secondary	Number of treatment emergent adverse events (TEAEs)	Count	From baseline (week 0) to week 12
Secondary	Number of treatment emergent gastrointestinal adverse events	Count	From baseline (week 0) to week 12
Secondary	Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes	Count	From baseline (week 0) to week 12
Secondary	Change in pulse rate	Beats per minute (bpm)	From baseline (week 0) to week 12
Secondary	Number of treatment emergent adverse events (TEAEs)	Count	From week 12 to week 17