A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT06326047
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 288
- Female of non-childbearing potential, or male.
- 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.
- Age 18-75 years (both inclusive) at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus greater than or equal 180 days before screening.
- 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.
- Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 millimoles per moles (mmol/mol)) (both inclusive) as assessed by central laboratory at screening.
- Body mass index (BMI) greater than or equal 23.0 kilograms per meter square (kg/m^2).
- 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.
- 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.
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dosing scheme A (NNC0519-0130) NNC0519-0130 Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as subcutaneous (s.c.) injection in dose escalating manner. Dosing scheme A (Placebo) Placebo Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods. Dosing scheme B (NNC0519-0130) NNC0519-0130 Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as s.c. injection in dose escalating manner. Dosing scheme B (Placebo) Placebo Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods. Dosing scheme C (Placebo) Placebo Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods. Dosing scheme D (Placebo) Placebo Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods. Dosing scheme E (Placebo) Placebo Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods. Dosing scheme F (tirzepatide) Trizepatide Participants will receive tirzepatide at 6 dose levels once weekly as s.c. injection in dose escalating manner. Dosing scheme C (NNC0519-0130) NNC0519-0130 Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner. Dosing scheme D (NNC0519-0130) NNC0519-0130 Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner. Dosing scheme E (NNC0519-0130) NNC0519-0130 Participants will receive NNC0519-0130 at 7 dose levels once weekly as s.c. injection in dose escalating manner.
- Primary Outcome Measures
Name Time Method Change in Glycated haemoglobin (HbA1c) From baseline (week 0) to 12 weeks on a given maintenance dose Measured as percentage point (%-point)
- Secondary Outcome Measures
Name Time Method Change in Glycated haemoglobin (HbA1c) From baseline (week 0) to end of treatment (week 36) Measured as percentage point (%-point)
Continuous glucose monitoring (CGM): Change in time in range (TIR) 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL)) From baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively Measured as percentage point (%-point)
Change in high sensitivity C-Reactive Protein (hsCRP) From baseline (week 0) to end of treatment (week 36) Measured as ratio to baseline
Relative change in body weight From baseline (week 0) to end of treatment (week 36) Measured as percentage (%)
Change in body weight From baseline (week 0) to end of treatment (week 36) Measured as kilograms (kg)
Change in fasting plasma glucose (FPG) From baseline (week 0) to 12 weeks on a given maintenance dose Measured as millimoles per liter (mmol/L)
Change in waist circumference From baseline (week 0) to end of treatment (week 36) Measured as centimeter (cm)
Change in systolic blood pressure (SBP) From baseline (week 0) to end of treatment (week 36) Measured as millimeters of mercury (mmHg)
Change in total cholesterol From baseline (week 0) to end of treatment (week 36) Measured as ratio to baseline
Change in high-density lipoprotein (HDL) cholesterol From baseline (week 0) to end of treatment (week 36) Measured as ratio to baseline
Change in low-density lipoprotein (LDL) cholesterol From baseline (week 0) to end of treatment (week 36) Measured as ratio to baseline
Change in triglycerides From baseline (week 0) to end of treatment (week 36) Measured as ratio to baseline
Number of adverse events From baseline (week 0) to end of study (week 40) Measured as number of events
Trial Locations
- Locations (92)
Velocity Clin Res-Chula Vista
🇺🇸Chula Vista, California, United States
Valley Research
🇺🇸Fresno, California, United States
310 Clinical Research
🇺🇸Inglewood, California, United States
Velocity Clin Res San Diego
🇺🇸La Mesa, California, United States
First Valley Med Grp Lancaster
🇺🇸Lancaster, California, United States
Torrance Clin Res Inst, Inc.
🇺🇸Lomita, California, United States
Pacific Clinical Studies
🇺🇸Los Alamitos, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Med Partners, Inc.
🇺🇸Toluca Lake, California, United States
UCLA Health Southbay Endocrine
🇺🇸Torrance, California, United States
University Clin Investigators
🇺🇸Tustin, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Innovative Research of W Florida Inc.
🇺🇸Clearwater, Florida, United States
Innovative Research of W FL
🇺🇸Clearwater, Florida, United States
International Research Associates, LLC_Miami
🇺🇸Miami, Florida, United States
Centricity Research
🇺🇸Columbus, Georgia, United States
Elite Clinical Trials
🇺🇸Blackfoot, Idaho, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Centennial Medical Group
🇺🇸Columbia, Maryland, United States
MD Medical Research
🇺🇸Oxon Hill, Maryland, United States
Endo And Metab Cons
🇺🇸Rockville, Maryland, United States
Clinvest Research
🇺🇸Springfield, Missouri, United States
Mercury Str Med Grp, PLLC
🇺🇸Butte, Montana, United States
Excel Clinical Network
🇺🇸Las Vegas, Nevada, United States
Palm Research Center Inc-Vegas
🇺🇸Las Vegas, Nevada, United States
Velocity Clinical Research Binghamton
🇺🇸Binghamton, New York, United States
PharmQuest Life Sciences LLC
🇺🇸Greensboro, North Carolina, United States
Accellacare Wilmington
🇺🇸Wilmington, North Carolina, United States
Diab & Endo Assoc of Stark Co
🇺🇸Canton, Ohio, United States
Velocity Clin Res_Cincinnati
🇺🇸Cincinnati, Ohio, United States
Velocity Clinical Research Springdale
🇺🇸Cincinnati, Ohio, United States
Providence Health Partners Ctr
🇺🇸Dayton, Ohio, United States
Advanced Med Res Maumee
🇺🇸Maumee, Ohio, United States
Tristar Clin Investigations, PC
🇺🇸Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians Inc.
🇺🇸Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians, Inc.
🇺🇸Uniontown, Pennsylvania, United States
Velocity Clinical Research Abilene
🇺🇸Abilene, Texas, United States
Velocity Clin Res Austin
🇺🇸Austin, Texas, United States
Velocity Clinical Res-Dallas
🇺🇸Dallas, Texas, United States
Zenos Clinical research
🇺🇸Dallas, Texas, United States
Care United Research, LLC
🇺🇸Forney, Texas, United States
Endocrine Associates Houston
🇺🇸Houston, Texas, United States
Biopharma Informatic_Houston
🇺🇸Houston, Texas, United States
Tekton Research
🇺🇸Irving, Texas, United States
Epic Clinical Research
🇺🇸Lewisville, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Burke Internal Medicine & Research
🇺🇸Burke, Virginia, United States
TPMG Clinical Research
🇺🇸Newport News, Virginia, United States
Macquarie University
🇦🇺Macquarie Park, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
Roger Chih Yu Chen
🇦🇺Sydney, New South Wales, Australia
Western Endocrine Blacktown
🇦🇺Sydney, New South Wales, Australia
Illawarra Diabetes Service Clinical Trials & Research Unit
🇦🇺Wollongong, New South Wales, Australia
University of Sunshine Coast
🇦🇺Birtinya, Queensland, Australia
Eastern Clinical Research Unit Box Hill
🇦🇺Box Hill, Victoria, Australia
Emeritus Research Melbourne
🇦🇺Camberwell, Victoria, Australia
Austin Health, Metabolic Disorders Centre
🇦🇺Heidelberg Heights, Victoria, Australia
The Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
OCT Research ULC (dba Okanagan Clinical Trials)
🇨🇦Richmond, British Columbia, Canada
Cook Street Medical Clinic
🇨🇦Victoria, British Columbia, Canada
G.A. Research Associates Ltd.
🇨🇦Moncton, New Brunswick, Canada
Nova Scotia Hlth Halifax
🇨🇦Halifax, Nova Scotia, Canada
Wharton Med Clin Trials
🇨🇦Hamilton, Ontario, Canada
Albion Finch Medical Centre
🇨🇦Toronto, Ontario, Canada
Centricity Research Quebec City
🇨🇦Levis, Quebec, Canada
Recherche GCP Research
🇨🇦Montreal, Quebec, Canada
Centricity Research Ville St. Laurent VSL
🇨🇦Ville Saint-Laurent, Quebec, Canada
Diex Recherche Quebec Inc.
🇨🇦Quebec, Canada
Life Care Hospital and Research Centre
🇮🇳Bangalore, Karnataka, India
Amrita Institute Of Medical Sciences & Research Centre
🇮🇳Kochi, Kerala, India
TOTALL Diabetes Hormone Institute
🇮🇳Indore, Madhya Pradesh, India
Seth GS Medical College & KEM Hospital
🇮🇳Mumbai, Maharashtra, India
Chellaram Diabetes Institute
🇮🇳Pune, Maharashtra, India
Diabetes, Thyroid and Endocrine Centre
🇮🇳Jaipur, Rajasthan, India
Christian Medical College Hospital, Vellore
🇮🇳Vellore, Tamil Nadu, India
Diabetes Research Center, Hyderabad
🇮🇳Hyderabad, Telangana, India
MS Ramaiah
🇮🇳Bengaluru, India
Tokuyama clinic
🇯🇵Chiba, Japan
Soka Sugiura Internal Medicine Clinic
🇯🇵Soka-shi, Saitama, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Tokyo, Japan
Fukuwa Clinic
🇯🇵Tokyo, Japan
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Nowon Eulji Medical Center, Eulji University
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Josha Research
🇿🇦Bloemfontein, Free State, South Africa
Wits Bara Clinical Trial Site
🇿🇦Johannesburg, Gauteng, South Africa
Shop#1 Health Emporium
🇿🇦Midrand, Gauteng, South Africa
Dr Pillay's Rooms
🇿🇦Durban, KwaZulu-Natal, South Africa
Dr T Padayachee
🇿🇦Umkomaas, KwaZulu-Natal, South Africa