## Protocol Section
### Identification Module
**NCT ID:** NCT04287179

**Acronym:** SUSTAIN SWITCH

**Brief Title:** 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

#### Organization Study ID Info
**ID:** NN9535-4650
#### Organization
**Class:** INDUSTRY
**Full Name:** Novo Nordisk A/S
#### Secondary ID Infos
**Domain:** World Health Organization (WHO)
**ID:** U1111-1242-5426
**Type:** OTHER
**Domain:** European Medicines Agency (EudraCT)
**ID:** 2019-004234-42
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2021-01-25

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-02-03

**Type:** ACTUAL

**Last Update Submit Date:** 2022-02-02

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2020-11-16

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-03-09

**Type:** ACTUAL

**Status Verified Date:** 2022-02

#### Study First Post Date
**Date:** 2020-02-27
**Type:** ACTUAL
**Study First Submit Date:** 2020-02-25
**Study First Submit QC Date:** 2020-02-25
**Why Stopped:** COVID19 impact on this trial was evaluated and a delay of at least 6-9 months was expected. In parallel, the development of a new type of pen injector, which was an important part of the trial, was ceased and thus this trial was cancelled.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Novo Nordisk A/S

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Diabetes Mellitus, Type 2

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Once-weekly semaglutide administered subcutaneously (s.c., under the skin) with or without oral antidiabetics (OADs). Start dose 0.50 mg.

**Intervention Names:**

- Drug: Semaglutide

**Label:** Semaglutide 0.50 mg

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Once-weekly semaglutide administered subcutaneously (s.c., under the skin) with or without oral antidiabetics (OADs). Start dose 0.25 mg.

**Intervention Names:**

- Drug: Semaglutide

**Label:** Semaglutide 0.25 mg

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Semaglutide 0.25 mg

- Semaglutide 0.50 mg

**Description:** Dose gradually increased over 12 weeks to 2.0 mg, followed by a 5 week maintenance period.

**Name:** Semaglutide

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Percent-point

**Measure:** Change in glycosylated haemoglobin (HbA1c)

**Time Frame:** From baseline (week 0) to week 12

#### Secondary Outcomes

**Description:** mmol/L

**Measure:** Change in fasting plasma glucose

**Time Frame:** From baseline (week 0) to week 12

**Description:** Kg

**Measure:** Change in body weight

**Time Frame:** From baseline (week 0) to week 12

**Description:** Count

**Measure:** Number of treatment emergent adverse events (TEAEs)

**Time Frame:** From baseline (week 0) to week 12

**Description:** Count

**Measure:** Number of treatment emergent gastrointestinal adverse events

**Time Frame:** From baseline (week 0) to week 12

**Description:** Count

**Measure:** Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes

**Time Frame:** From baseline (week 0) to week 12

**Description:** Beats per minute (bpm)

**Measure:** Change in pulse rate

**Time Frame:** From baseline (week 0) to week 12

**Description:** Count

**Measure:** Number of treatment emergent adverse events (TEAEs)

**Time Frame:** From week 12 to week 17

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Buena Park

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** California

**Zip:** 90620

**Location 2:**

**City:** Fresno

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** California

**Zip:** 93720

**Location 3:**

**City:** San Jose

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** California

**Zip:** 95148

**Location 4:**

**City:** Walnut Creek

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** California

**Zip:** 94598

**Location 5:**

**City:** Waterbury

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Connecticut

**Zip:** 06708

**Location 6:**

**City:** Honolulu

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Hawaii

**Zip:** 96814

**Location 7:**

**City:** Idaho Falls

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Idaho

**Zip:** 83404-7596

**Location 8:**

**City:** Indianapolis

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Indiana

**Zip:** 46260

**Location 9:**

**City:** Troy

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Michigan

**Zip:** 48098

**Location 10:**

**City:** Albany

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** New York

**Zip:** 12206

**Location 11:**

**City:** West Seneca

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** New York

**Zip:** 14224

**Location 12:**

**City:** Dallas

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Texas

**Zip:** 75390-9302

**Location 13:**

**City:** Round Rock

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Texas

**Zip:** 78681

**Location 14:**

**City:** Sugar Land

**Country:** United States

**Facility:** Novo Nordisk Investigational Site

**State:** Texas

**Zip:** 77478

**Location 15:**

**City:** Graz

**Country:** Austria

**Facility:** Novo Nordisk Investigational Site

**Zip:** 8036

**Location 16:**

**City:** Stockerau

**Country:** Austria

**Facility:** Novo Nordisk Investigational Site

**Zip:** 2000

**Location 17:**

**City:** Wien

**Country:** Austria

**Facility:** Novo Nordisk Investigational Site

**Zip:** 1090

**Location 18:**

**City:** Wien

**Country:** Austria

**Facility:** Novo Nordisk Investigational Site

**Zip:** 1130

**Location 19:**

**City:** Jyväskylä

**Country:** Finland

**Facility:** Novo Nordisk Investigational Site

**Zip:** 40100

**Location 20:**

**City:** Kuopio

**Country:** Finland

**Facility:** Novo Nordisk Investigational Site

**Zip:** 70100

**Location 21:**

**City:** Lahti

**Country:** Finland

**Facility:** Novo Nordisk Investigational Site

**Zip:** 15100

**Location 22:**

**City:** Raisio

**Country:** Finland

**Facility:** Novo Nordisk Investigational Site

**Zip:** 21200

**Location 23:**

**City:** Seinäjoki

**Country:** Finland

**Facility:** Novo Nordisk Investigational Site

**Zip:** 60220

**Location 24:**

**City:** Göteborg

**Country:** Sweden

**Facility:** Novo Nordisk Investigational Site

**Zip:** 413 45

**Location 25:**

**City:** Malmö

**Country:** Sweden

**Facility:** Novo Nordisk Investigational Site

**Zip:** 205 02

#### Overall Officials

**Official 1:**

**Affiliation:** Novo Nordisk A/S

**Name:** Clinical Reporting Anchor & Disclosure (1452)

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** According to the Novo Nordisk disclosure commitment on novonordisk-trials. com

**IPD Sharing:** YES

**URL:** http://novonordisk-trials.com

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes Mellitus

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 2

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Intervention Browse Module - Ancestors

- ID: D000097789

- Term: Glucagon-Like Peptide-1 Receptor Agonists

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M353561

- Name: Semaglutide

- Relevance: HIGH

- As Found: Physical therapy

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M26997

- Name: Glucagon-Like Peptide 1

- Relevance: LOW

- As Found: Unknown

- ID: M16204

- Name: Sulfamethazine

- Relevance: LOW

- As Found: Unknown

- ID: M9043

- Name: Glucagon

- Relevance: LOW

- As Found: Unknown

- ID: M3401

- Name: Glucagon-Like Peptide-1 Receptor Agonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000591245

- Term: Semaglutide

### Misc Info Module

- Version Holder: 2024-05-24
