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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05035082
Other study ID # NN9924-4558
Secondary ID U1111-1253-2577
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 1, 2021
Est. completion date June 9, 2025

Study information

Verified date August 2023
Source Novo Nordisk A/S
Contact Novo Nordisk
Phone (+1) 866-867-7178
Email clinicaltrials@novonordisk.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is comparing the medicine RYBELSUS® to other medicines in people with type 2 diabetes who need extra treatment. All medicines used in this study are tablets which lower blood sugar in people with type 2 diabetes. The purpose of the study is to see how well RYBELSUS® is at lowering blood sugar compared to other tablets when used in addition to metformin. Participants doctor will give participants either RYBELSUS® or any other blood sugar lowering tablets - which treatment participants get is decided by chance. The doctor treating participants diabetes will give participants a prescription for the medicine and tell how to take it. The study will last for about 1 year. Participants will have 2 planned visits with their doctor which are part of the usual routine diabetes management: the first visit is when participants are included in the study, the second visit is a 1-year follow-up visit. In addition, the study personnel will contact participants up to 3 times during this period and to follow-up on information from participant doctors visits. Participant will be asked to respond 3 times to 4 questionnaires via their personal smartphone or tablet or paper if participant do not have access to one during the study. All clinic visits are part of the usual routine diabetes management and are covered by participants health insurance plan. The study team will collect information from these visits recorded in the medical chart. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Recruitment information / eligibility

Status Recruiting
Enrollment 1262
Est. completion date June 9, 2025
Est. primary completion date February 7, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key inclusion criteria - Treatment with metformin as monotherapy prior to eligibility assessment that has failed to result in adequate glycemic control at the discretion of the investigator or treatment provider. However, prior short-term treatment with an oral glucose lowering agent or insulin for up to 14 consecutive days in addition to metformin is allowed if discontinued prior to screening. - Current member of a health plan which includes pharmacy benefits. - HbA1c greater than or equal to 7% within last 90 days prior to the day of screening or to be taken before randomization. - Further intensification with an additional glucose-lowering oral agent including oral semaglutide is indicated according to approved prescribing information to achieve glycemic target at the discretion of the treatment provider. Key exclusion criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using contraception. - Any disorder which in the investigator's or treatment provider's opinion might jeopardize patient's safety.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
semaglutide
Oral administration The doctor will give a prescription for the medicine and tell how to take it.
oral glucose-lowering medications (commercially available)
Oral administration The doctor will give a prescription for the medicine and tell how to take it.

Locations

Country Name City State
United States Novo Nordisk Investigational Site Alhambra California
United States Novo Nordisk Investigational Site Anderson South Carolina
United States Novo Nordisk Investigational Site Burlington North Carolina
United States Novo Nordisk Investigational Site Canton Ohio
United States Novo Nordisk Investigational Site Charlotte North Carolina
United States Novo Nordisk Investigational Site Columbus Ohio
United States Novo Nordisk Investigational Site Costa Mesa California
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Fargo North Dakota
United States Novo Nordisk Investigational Site Garner North Carolina
United States Novo Nordisk Investigational Site Gastonia North Carolina
United States Novo Nordisk Investigational Site Gillespie Illinois
United States Novo Nordisk Investigational Site La Jolla California
United States Novo Nordisk Investigational Site Marietta Georgia
United States Novo Nordisk Investigational Site Marietta Georgia
United States Novo Nordisk Investigational Site Miami Florida
United States Novo Nordisk Investigational Site New Braunfels Texas
United States Novo Nordisk Investigational Site Peoria Illinois
United States Novo Nordisk Investigational Site Philadelphia Pennsylvania
United States Novo Nordisk Investigational Site Philadelphia Pennsylvania
United States Novo Nordisk Investigational Site Pittsburgh Pennsylvania
United States Novo Nordisk Investigational Site Riverside California
United States Novo Nordisk Investigational Site Saint George Utah
United States Novo Nordisk Investigational Site San Antonio Texas
United States Novo Nordisk Investigational Site Skokie Illinois

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Glycosylated hemoglobin A1c (HbA1c) percentage-points From randomization to year 1
Secondary Patient achieving HbA1c below 7.0% (Yes /No) Count of patient(s) Year 1
Secondary Patient achieving HbA1c below or equal to 6.5% (Yes/No) Count of patient(s) Year 1
Secondary Patient achieving HbA1c below 7.0% or at least 1.0%-point reduction in HbA1c (Yes/No) Count of patient(s) From randomization to year 1
Secondary Patient achieving greater than or equal to 5% reduction in body weight (Yes/No) Count of patient(s) From randomization to year 1
Secondary Patient achieving individualized HbA1c target per Healthcare Effectiveness Data and Information Set (HEDIS) criteria (below 8.0% if age greater than or equal to 65 years or with defined comorbidities or otherwise below 7.0%) (Yes/No) Count of patient(s) Year 1
Secondary Patient achieving HbA1c less than or equal to treatment provider defined individualized target (Yes/No) Count of patient(s) Year 1
Secondary Relative change in body weight (%) Percentage From randomization to year 1
Secondary Change in body weight (lbs) Lbs From randomization to year 1
Secondary Time to treatment intensification (add-on) or change (switch) Days From randomization to year 1
Secondary Diabetes Treatment Satisfaction Questionnaire, change version (DTSQc), Relative treatment satisfaction total score Score on a scale (The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) will be used to measure the change in patient satisfaction with their diabetes treatment. It consists of a six-item scale assessing treatment satisfaction and two items assessing perceived frequency of hyperglycaemia and hypoglycaemia. The DTSQc items are on a scale from 3 to -3. If they experience no change, then 0 is chosen. Higher score indicate higher satisfaction with their current treatment) Year 1
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