COMPLETED

A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes

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Conditions

Type 2 Diabetes (T2D)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study will look at how well different doses of a new medicine called NNC0487-0111 help lower the blood sugar and body weight in people with type 2 diabetes. NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Participants will either get NNC0487-0111, which is given as tablets or as injections, or placebo. Which treatment the participant get is decided by chance.The study will last for about 43 weeks.

Official Title

Safety and Efficacy of Once-weekly Subcutaneous and Once-daily Oral NNC0487-0111 in Participants With Type 2 Diabetes - a Dose Finding Study

Quick Facts

Study Start:2024-08-07
Study Completion:2025-10-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06542874

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female, aged 18-75 years (both inclusive) at the time of signing the informed consent.
  2. * Diagnosed with type 2 diabetes mellitus greater or equal to 180 days before screening.
  3. * Stable daily dose(s) greater or equal to 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without SGLT2 inhibitor.
  4. * HbA1c of 7.0-10.0 procent (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening.
  5. * Body mass index between greater or equal to 23.0 and below 50.0 kg/m\^2.
  6. * Able and willing to adhere to the protocol including wearing a continuous glucose monitoring (CGM) device provided for the study, as judged by the investigator.
  1. * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
  2. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before 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.
  3. * Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.

Contacts and Locations

Principal Investigator

Clinical Transparency (dept. 2834)
STUDY_DIRECTOR
Novo Nordisk A/S

Study Locations (Sites)

Southern Cal Clinical Research
Santa Ana, California, 92701
United States
Chase Medical Research LLC
Waterbury, Connecticut, 06708
United States
Fleming Island Ctr for Clin Res
Fleming Island, Florida, 32003
United States
Encore Medical Research LLC
Hollywood, Florida, 33024
United States
South Broward Research LLC
Miramar, Florida, 33027
United States
Florida Inst For Clin Res
Orlando, Florida, 32825
United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607
United States
Advanced Internal Medicine, PLLC
Paducah, Kentucky, 42001
United States
Medstar Research Institute_Hyattsville
Hyattsville, Maryland, 20782
United States
MD Medical Research
Oxon Hill, Maryland, 20745
United States
Arcturus HC PLC Troy Med Res
Troy, Michigan, 48098
United States
Arcturus Healthcare, PLC
Troy, Michigan, 48098
United States
Clinical Research Professionals
Chesterfield, Missouri, 63005
United States
AMC Community Endocrinology
Albany, New York, 12203
United States
Lucas Research Inc.
Morehead City, North Carolina, 28557
United States
Piedmont Healthcare/Research
Statesville, North Carolina, 28625
United States
Plains Clinical Research Center, LLC_Fargo
Fargo, North Dakota, 58104
United States
Preferred Primary Care Physicians_Pittsburgh
Pittsburgh, Pennsylvania, 15236
United States
Health Concepts
Rapid City, South Dakota, 57702
United States
Clinical Research Associates
Nashville, Tennessee, 37203
United States
MidState Endocrine Associates
Nashville, Tennessee, 37203
United States
Velocity Clinical Res-Dallas
Dallas, Texas, 75230
United States
Victorium Clinical Research
Houston, Texas, 77024
United States
Synergy Groups Medical
Houston, Texas, 77061
United States
PlanIt Research, PLLC
Houston, Texas, 77079
United States
Radiance Clinical Research
Lampasas, Texas, 76550
United States
Tekton Research
McKinney, Texas, 75069
United States
Hillcrest Family Health Center
Waco, Texas, 76708
United States

Collaborators and Investigators

Sponsor: Novo Nordisk A/S

  • Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-07
Study Completion Date2025-10-24

Study Record Updates

Study Start Date2024-08-07
Study Completion Date2025-10-24

Terms related to this study

Additional Relevant MeSH Terms

  • Type 2 Diabetes (T2D)