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

Part of paid clinical trials in Buena Park, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT04287179
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 9, 2020
Status verified
Feb 2022
Primary completion
Nov 16, 2020
Completion
Jan 25, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in glycosylated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to week 12 ]

Locations (14)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteBuena ParkCalifornia90620-
Novo Nordisk Investigational SiteFresnoCalifornia93720-
Novo Nordisk Investigational SiteSan JoseCalifornia95148-
Novo Nordisk Investigational SiteWalnut CreekCalifornia94598-
Novo Nordisk Investigational SiteWaterburyConnecticut06708-
Novo Nordisk Investigational SiteHonoluluHawaii96814-
Novo Nordisk Investigational SiteIdaho FallsIdaho83404-7596-
Novo Nordisk Investigational SiteIndianapolisIndiana46260-
Novo Nordisk Investigational SiteTroyMichigan48098-
Novo Nordisk Investigational SiteAlbanyNew York12206-
Novo Nordisk Investigational SiteWest SenecaNew York14224-
Novo Nordisk Investigational SiteDallasTexas75390-9302-
Novo Nordisk Investigational SiteRound RockTexas78681-
Novo Nordisk Investigational SiteSugar LandTexas77478-

Find similar trials in Buena Park, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Novo Nordisk Investigational Site· Buena Park, CANovo Nordisk Investigational Site· Fresno, CANovo Nordisk Investigational Site· San Jose, CANovo Nordisk Investigational Site· Walnut Creek, CANovo Nordisk Investigational Site· Waterbury, CTNovo Nordisk Investigational Site· Honolulu, HI

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