COMPLETED

A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes

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Conditions

Diabetes Mellitus, Type 2

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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

This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of NNC0519-0130. Which treatment participant will get is decided by chance. Participants will take 1-3 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 40 weeks.

Official Title

Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Type 2 Diabetes - a Dose Finding Study

Quick Facts

Study Start:2024-03-18
Study Completion:2025-10-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06326047

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. * Female of non-childbearing potential, or male.
  2. * For United States (US) only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency and willingness to continue using it through-out the study or male.
  3. * Age 18-75 years (both inclusive) at the time of signing the informed consent.
  4. * Diagnosed with type 2 diabetes mellitus greater than or equal 180 days before screening.
  5. * Stable daily dose(s) more than or equal 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 sodium-glucose co-transporter 2 (SGLT2) inhibitor.
  6. * Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 millimoles per moles (mmol/mol)) (both inclusive) as assessed by central laboratory at screening.
  7. * Body mass index (BMI) greater than or equal 23.0 kilograms per meter square (kg/m\^2).
  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)

Velocity Clin Res-Chula Vista
Chula Vista, California, 91911
United States
Valley Research
Fresno, California, 93720
United States
310 Clinical Research
Inglewood, California, 90301
United States
Velocity Clin Res San Diego
La Mesa, California, 91942
United States
First Valley Med Grp Lancaster
Lancaster, California, 93534
United States
Torrance Clin Res Inst, Inc.
Lomita, California, 90717
United States
Pacific Clinical Studies
Los Alamitos, California, 90720
United States
Catalina Research Institute, LLC
Montclair, California, 91763
United States
Med Partners, Inc.
Toluca Lake, California, 91602
United States
University Clin Investigators
Tustin, California, 92780
United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
United States
University of Colorado Hospital
Aurora, Colorado, 80045
United States
Innovative Research of W Florida Inc.
Clearwater, Florida, 33756
United States
Innovative Research of W FL
Clearwater, Florida, 33756
United States
International Research Associates, LLC_Miami
Miami, Florida, 33183
United States
Centricity Research
Columbus, Georgia, 31904
United States
Elite Clinical Trials
Blackfoot, Idaho, 83221
United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61603
United States
Centennial Medical Group
Columbia, Maryland, 21045
United States
MD Medical Research
Oxon Hill, Maryland, 20745
United States
Clinvest Research
Springfield, Missouri, 65807
United States
Mercury Str Med Grp, PLLC
Butte, Montana, 59701
United States
Excel Clinical Network
Las Vegas, Nevada, 89109
United States
Palm Research Center Inc-Vegas
Las Vegas, Nevada, 89148
United States
Velocity Clinical Research Binghamton
Binghamton, New York, 13905
United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408
United States
Accellacare Wilmington
Wilmington, North Carolina, 28401
United States
Diab & Endo Assoc of Stark Co
Canton, Ohio, 44718
United States
Velocity Clin Res_Cincinnati
Cincinnati, Ohio, 45242
United States
Velocity Clinical Research Springdale
Cincinnati, Ohio, 45246
United States
Providence Health Partners Ctr
Dayton, Ohio, 45439
United States
Advanced Med Res Maumee
Maumee, Ohio, 43537
United States
Preferred Primary Care Physicians Inc.
Pittsburgh, Pennsylvania, 15243
United States
Preferred Primary Care Physicians, Inc.
Uniontown, Pennsylvania, 15401
United States
Velocity Clinical Research Abilene
Abilene, Texas, 79606
United States
Velocity Clin Res Austin
Austin, Texas, 78759
United States
Velocity Clinical Res-Dallas
Dallas, Texas, 75230
United States
Zenos Clinical research
Dallas, Texas, 75230
United States
Care United Research, LLC
Forney, Texas, 75126
United States
Biopharma Informatic_Houston
Houston, Texas, 77043
United States
Tekton Research
Irving, Texas, 75039
United States
Epic Clinical Research
Lewisville, Texas, 75057
United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
United States
Burke Internal Medicine & Research
Burke, Virginia, 22015
United States
TPMG Clinical Research
Newport News, Virginia, 23606
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 Date2024-03-18
Study Completion Date2025-10-13

Study Record Updates

Study Start Date2024-03-18
Study Completion Date2025-10-13

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 2