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A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3)
Sponsor: Novo Nordisk A/S
Summary
This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (an insulin taken once daily which is already available on the market) in people with type 2 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily. Participants will get their study medicine in an injection pen. Participants will get a pen for weekly injection and one for daily injection. One will be icodec or degludec and the other will be dummy medicine. The treatment participants get is decided by chance. Participants and the study staff will not know which active medicine they get. The insulin is injected with a needle in a skin fold in the thigh. The study could last for about 8 months. Participants will have 13 clinic visits and 17 phone calls with the study doctor. At 8 clinic visits participants will have blood samples taken. At 4 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
Official title: A 26-week Double Blinded, Multiregional, Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Drugs, in Insulin naïve Subjects With Type 2 Diabetes.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
588
Start Date
2021-03-24
Completion Date
2022-06-23
Last Updated
2026-06-12
Healthy Volunteers
No
Conditions
Interventions
Insulin icodec
You will get a pen for weekly injection and one for daily injection. One will be icodec 700 units/mL and the other will be placebo. Subcutaneously (under the skin) injections
Placebo insulin icodec
You will get a pen for weekly injection and one for daily injection. One will be insulin degludec 100 units/mL and the other will be placebo. Subcutaneously (under the skin) injections
Insulin degludec
You will get a pen for weekly injection and one for daily injection. One will be degludec 100 units/mL and the other will be placebo. Subcutaneously (under the skin) injections
Placebo insulin degludec
You will get a pen for weekly injection and one for daily injection. One will be icodec 700 units/mL and the other will be placebo. Subcutaneously (under the skin) injections
Locations (190)
Univ of Alabama Birmingham
Birmingham, Alabama, United States
Lakeview Clinical Research, LLC
Guntersville, Alabama, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Advanced Clinical Research/Rancho Paseo Medical Group
Banning, California, United States
American Clinical Trials
Buena Park, California, United States
Med Center Medical Clinic
Carmichael, California, United States
Headlands Research California, LLC
Escondido, California, United States
Valley Research
Fresno, California, United States
Scripps Whittier Diabetes Inst
La Jolla, California, United States
First Valley Medical Group
Lancaster, California, United States
Clinical Trials Research_Sacramento
Lincoln, California, United States
Torrance Clin Res Inst, Inc.
Lomita, California, United States
Providence Clinical Research
North Hollywood, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
NorCal Endocrinology and Internal Medicine
San Ramon, California, United States
Diabetes Research Center
Tustin, California, United States
Coastal Metabolic Research Center
Ventura, California, United States
Denver Endocrinology Diabetes and Thyroid Center
Englewood, Colorado, United States
Chase Medical Research LLC
Waterbury, Connecticut, United States
Revival Research
Doral, Florida, United States
Est Cst Inst for Rsrch,Jksnvil
Jacksonville, Florida, United States
Jacksonville Ctr For Clin Res
Jacksonville, Florida, United States
University Of Miami
Miami, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Florida Institute for Clinical research
Orlando, Florida, United States
Palm Harbor Medical Associates
Palm Harbor, Florida, United States
Suncoast Clinical Research, Inc.
Palm Harbor, Florida, United States
Metabolic Research Institute Inc
West Palm Beach, Florida, United States
Clinical Research of Cent FL
Winter Haven, Florida, United States
Physicians Research Assoc. LLC
Lawrenceville, Georgia, United States
RNA America Health Sciences
Sugar Hill, Georgia, United States
East West Med Res Inst
Honolulu, Hawaii, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, United States
Cotton-Oneill Diabetes and End
Topeka, Kansas, United States
St Elizabeth Physicians Heart
Covington, Kentucky, United States
Four Rivers Clinical Research Inc
Paducah, Kentucky, United States
MedStar Community Clin Res Ctr
Hyattsville, Maryland, United States
Endo and Metab Consultants
Rockville, Maryland, United States
Arcturus HC PLC Troy Med Res
Troy, Michigan, United States
Diabetes & Endo Specialists Inc
Chesterfield, Missouri, United States
Methodist Physicians Clin
Omaha, Nebraska, United States
Univ of Nebraska Medical CTR
Omaha, Nebraska, United States
Palm Research Center Inc-Vegas
Las Vegas, Nevada, United States
Southern New Hampshire Diabete
Nashua, New Hampshire, United States
Albuquerque Clin Trials, Inc.
Albuquerque, New Mexico, United States
N.Y. Total Medical Care PC
Brooklyn, New York, United States
Northwell Health Div of Endo
Great Neck, New York, United States
NYU Grossman School of Med
New York, New York, United States
Endocrine Associates of Long Island, PC
Smithtown, New York, United States
Southgate Medical Group, LLP
West Seneca, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Physician's East Endocrinology
Greenville, North Carolina, United States
Medication Management, LLC
Raleigh, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
Ardmore Family Practice
Winston-Salem, North Carolina, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Plains Clinical Research Center, LLC
Fargo, North Dakota, United States
Diab & Endo Assoc of Stark Co
Canton, Ohio, United States
Providence Health Partners Ctr
Dayton, Ohio, United States
Prestige Clinical Research
Franklin, Ohio, United States
Your Diabetes Endocrine Nutrition Group, Inc.
Mentor, Ohio, United States
Clinical Research Source Inc
Perrysburg, Ohio, United States
Daniel G Williams MD
Perrysburg, Ohio, United States
Intend Research
Norman, Oklahoma, United States
Oregon Health & Science University_Portland_0
Portland, Oregon, United States
Heritage Valley Multispeciality Group Inc
Beaver, Pennsylvania, United States
The Diabetes Center, LLC
Murrells Inlet, South Carolina, United States
Hillcrest Clinical Research
Simpsonville, South Carolina, United States
AM Diabetes And Endocrinology Center
Bartlett, Tennessee, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Texas Diab & Endo, P.A.
Austin, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
North Texas Endocrine Center
Dallas, Texas, United States
UT Southwestern Med Cntr
Dallas, Texas, United States
PrimeCare Medical Group
Houston, Texas, United States
JCCT- Juno NW Houston
Houston, Texas, United States
Fmc Science, Llc
Lampasas, Texas, United States
Texas Diab & Endo, P.A.
Round Rock, Texas, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
NE Clin Res of San Antonio
San Antonio, Texas, United States
Simcare Medical Research, LLC
Sugar Land, Texas, United States
Elite Medical Care
Sugar Land, Texas, United States
Wade Family Medicine
Bountiful, Utah, United States
Advanced Research Institute
Ogden, Utah, United States
Chrysalis Clinical Research
St. George, Utah, United States
Spectrum Medical, Inc
Danville, Virginia, United States
TPMG Clinical Research
Newport News, Virginia, United States
Rainier Clin Res Ctr Inc
Renton, Washington, United States
Clinical Investigation Specialists Inc, Kenosha
Kenosha, Wisconsin, United States
STAT Research
Buenos Aires, Argentina
CEDIC Centro de Investigación Clínica
CABA, Argentina
CENUDIAB Centro Médico de Nutrición v Diabetes
CABA, Argentina
Instituto de Clínica Médica y Diabetes
Mendoza, Argentina
Universitätsklinik für Innere Medizin Graz
Graz, Austria
Universitätsklinik für Innere Medizin
Graz, Austria