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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT04287179
• Collaborator: (none)
• Enrollment: 0
• Locations: 25
• Arms: 2
• Anticipated Duration (Months): 10.6
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Semaglutide	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 9, 2020
• Anticipated Primary Completion Date: Nov 16, 2020
• Anticipated Study Completion Date: Jan 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Semaglutide 0.50 mg Once-weekly semaglutide administered subcutaneously (s.c., under the skin) with or without oral antidiabetics (OADs). Start dose 0.50 mg.	Drug: Semaglutide; Dose gradually increased over 12 weeks to 2.0 mg, followed by a 5 week maintenance period.
Active Comparator: Semaglutide 0.25 mg Once-weekly semaglutide administered subcutaneously (s.c., under the skin) with or without oral antidiabetics (OADs). Start dose 0.25 mg.	Drug: Semaglutide; Dose gradually increased over 12 weeks to 2.0 mg, followed by a 5 week maintenance period.

Outcome Measures

Primary Outcome Measures

1. Change in glycosylated haemoglobin (HbA1c) [From baseline (week 0) to week 12]

   Percent-point

Secondary Outcome Measures

1. Change in fasting plasma glucose [From baseline (week 0) to week 12]

   mmol/L

2. Change in body weight [From baseline (week 0) to week 12]

   Kg

3. Number of treatment emergent adverse events (TEAEs) [From baseline (week 0) to week 12]

   Count

4. Number of treatment emergent gastrointestinal adverse events [From baseline (week 0) to week 12]

   Count

5. Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes [From baseline (week 0) to week 12]

   Count

6. Change in pulse rate [From baseline (week 0) to week 12]

   Beats per minute (bpm)

7. Number of treatment emergent adverse events (TEAEs) [From week 12 to week 17]

   Count

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Buena Park	California	United States	90620
2	Novo Nordisk Investigational Site	Fresno	California	United States	93720
3	Novo Nordisk Investigational Site	San Jose	California	United States	95148
4	Novo Nordisk Investigational Site	Walnut Creek	California	United States	94598
5	Novo Nordisk Investigational Site	Waterbury	Connecticut	United States	06708
6	Novo Nordisk Investigational Site	Honolulu	Hawaii	United States	96814
7	Novo Nordisk Investigational Site	Idaho Falls	Idaho	United States	83404-7596
8	Novo Nordisk Investigational Site	Indianapolis	Indiana	United States	46260
9	Novo Nordisk Investigational Site	Troy	Michigan	United States	48098
10	Novo Nordisk Investigational Site	Albany	New York	United States	12206
11	Novo Nordisk Investigational Site	West Seneca	New York	United States	14224
12	Novo Nordisk Investigational Site	Dallas	Texas	United States	75390-9302
13	Novo Nordisk Investigational Site	Round Rock	Texas	United States	78681
14	Novo Nordisk Investigational Site	Sugar Land	Texas	United States	77478
15	Novo Nordisk Investigational Site	Graz		Austria	8036
16	Novo Nordisk Investigational Site	Stockerau		Austria	2000
17	Novo Nordisk Investigational Site	Wien		Austria	1090
18	Novo Nordisk Investigational Site	Wien		Austria	1130
19	Novo Nordisk Investigational Site	Jyväskylä		Finland	40100
20	Novo Nordisk Investigational Site	Kuopio		Finland	70100
21	Novo Nordisk Investigational Site	Lahti		Finland	15100
22	Novo Nordisk Investigational Site	Raisio		Finland	21200
23	Novo Nordisk Investigational Site	Seinäjoki		Finland	60220
24	Novo Nordisk Investigational Site	Göteborg		Sweden	413 45
25	Novo Nordisk Investigational Site	Malmö		Sweden	205 02

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Reporting Anchor & Disclosure (1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT04287179
• Other Study ID Numbers: NN9535-4650; U1111-1242-5426; 2019-004234-42
• First Posted: Feb 27, 2020
• Last Update Posted: Feb 3, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Feb 3, 2022