NCT03648281|Completed

A Research Study Looking at How Semaglutide Works in People With Type 2 Diabetes in Denmark and Sweden, as Part of Local Clinical Practice (SURE DENMARK/SWEDEN)

SURE DENMARK/SWEDEN: A Multi-centre, Prospective, Non-interventional Study Investigating the Effectiveness of Once-weekly Subcutaneous Semaglutide in a Real World Adult Population With Type 2 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN9535-4367U1111-1204-5181

Study Type

observational

Target

333

Locations

2 countries

Sites

Timeline

RegisteredAug 2018

StartedAug 2018

CompletionJan 2020

Brief Summary

The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by the study doctor. The study will last for about 6 to 8 months. Participants will be asked to complete some questionnaires about their health and diabetes treatment. Participants will complete these questionnaires during their normally scheduled visits with the study doctor.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

333

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Aug 2018

Geographic Reach

2 countries

30 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

First Submitted

Initial submission to the registry

August 24, 2018

Completed

Same day until next milestone

Study Start

First participant enrolled

August 24, 2018

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed

Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

1.4 years

First QC Date

August 24, 2018

Last Update Submit

November 12, 2021

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

Change in Glycated Haemoglobin A1c (HbA1c)
Measured in % points
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Change in HbA1c
Measured in mmol/mol
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)

Secondary Outcomes (16)

Change in body weight
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Change in body weight
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
Change in waist circumference
Baseline (up to 12 weeks prior to treatment initiation at week 0), end of study (week 28 to 38)
HbA1c level at end of study: <8.0% (64 mmol/mol) (yes/no)
At end of study (week 28 to 38)
HbA1c level at end of study: <7.5% (59 mmol/mol) (yes/no)
At end of study (week 28 to 38)
+11 more secondary outcomes

Study Arms (1)

Semaglutide

Participants will receive semaglutide at the treating physician's discretion as part of the usual clinical practice. The prescription and use of semaglutide is completely independent of this study. Total study duration for the individual patient will be approximately 30 weeks.

Drug: Semaglutide

Interventions

SemaglutideDRUG

Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion.

Semaglutide

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Participants with type 2 diabetes

Contact the study team to confirm eligibility.