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)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Placebo insulin icodecDrug: Placebo insulin degludec
- Registration Number
- NCT04795531
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 588
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Male or female aged above or equal to 18 years at the time of signing informed consent.
-
Diagnosed with T2D (type 2 diabetes) greater than or equal to 180 days prior to the day of screening.
-
HbA1c (glycated haemoglobin) from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
-
Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
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Stable daily dose(s) greater than or equal to 90 days prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s):
a.) Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. b.) Any metformin combination formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. c.) Any of the following oral anti-diabetic drug classes including combinations (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose).:Sulfonylureas - Meglitinides (glinides) - DPP-4 inhibitors - SGLT2 inhibitors - Thiazolidinediones - Alpha-glucosidase inhibitors - Oral combination products (for the allowed individual Oral Anti-diabetic Drugs (OADs)) - Oral or injectable GLP-1-receptor agonists
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Body mass index (BMI) below or equal to 40.0 kg/m^2.
- Any episodes (as declared by the subject or in the medical records) of diabetic ketoacidosis within 90 days prior to the day of screening.
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Once weekly insulin icodec + once daily placebo Placebo insulin degludec Participants will get once daily and once weekly injections Once weekly placebo and once daily insulin degludec Placebo insulin icodec Participants will get once daily and once weekly injections Once weekly placebo and once daily insulin degludec Insulin degludec Participants will get once daily and once weekly injections Once weekly insulin icodec + once daily placebo Insulin icodec Participants will get once daily and once weekly injections
- Primary Outcome Measures
Name Time Method Change in Glycated Haemoglobin (HbA1c) Baseline (Week 0), Week 26 Change in HbA1c from baseline (week 0) to week 26 is presented. The outcome data is evaluated based on the in-trial observation period. The in-trial period started at randomisation and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
- Secondary Outcome Measures
Name Time Method Change in Fasting Plasma Glucose (FPG) Baseline (Week 0), Week 26 Change in FPG from baseline (week 0) to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomisation and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
Number of Severe Hypoglycaemic Episodes (Level 3) From baseline (week 0) to week 26 Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (< 3.0 mmol/L (54 Milligrams Per Deciliter [mg/dL]), Confirmed by Blood Glucose [BG] Meter) From baseline (week 0) to week 31 Number of clinically significant hypoglycaemic episodes (level 2) (less than \[\<\] 3.0 millimoles per liter (mmol/L) (54 mg/dL), confirmed by BG meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on the on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3) From baseline (week 0) to week 26 Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (\<) 3.0 millimoles per liter (mmol/L) (54 milligrams per deciliter \[mg/dL\]) confirmed by blood glucose (BG) meter.
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) From baseline (week 0) to week 26 Number of clinically significant hypoglycaemic episodes (level 2) (\< 3.0 mmol/L (54 mg/dL), confirmed by BG meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (\<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter.
Change in Body Weight Baseline (Week 0), Week 26 Change in body weight from baseline (week 0) to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. The in-trial period started at randomisation and ended at the date of: the last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above.
Mean Weekly Insulin Dose From week 24 to week 26 Estimated mean weekly insulin dose during the last 2 weeks of treatment (from week 24 to week 26) is presented. The outcome data was evaluated based on the on-treatment period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product.
Trial Locations
- Locations (55)
Novo Nordisk Investigational Site
🇨🇳Taipei, Taiwan
Lakeview Clinical Research, LLC
🇺🇸Guntersville, Alabama, United States
American Clinical Trials
🇺🇸Buena Park, California, United States
Headlands Research California, LLC
🇺🇸Escondido, California, United States
Valley Research
🇺🇸Fresno, California, United States
First Valley Medical Group
🇺🇸Lancaster, California, United States
Est Cst Inst for Rsrch,Jksnvil
🇺🇸Jacksonville, Florida, United States
Palm Harbor Medical Associates
🇺🇸Palm Harbor, Florida, United States
Metabolic Research Institute Inc
🇺🇸West Palm Beach, Florida, United States
Cedar-Crosse Research Center
🇺🇸Chicago, Illinois, United States
Cotton-Oneill Diabetes and End
🇺🇸Topeka, Kansas, United States
Arcturus Healthcare, PLC
🇺🇸Troy, Michigan, United States
Southgate Medical Group, LLP
🇺🇸West Seneca, New York, United States
Physician's East Endocrinology
🇺🇸Greenville, North Carolina, United States
Accellacare
🇺🇸Wilmington, North Carolina, 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
Intend Research
🇺🇸Norman, Oklahoma, United States
Hillcrest Clinical Research
🇺🇸Simpsonville, South Carolina, United States
Velocity Clinical Res-Dallas
🇺🇸Dallas, Texas, United States
UT Southwestern Med Cntr
🇺🇸Dallas, Texas, United States
PrimeCare Medical Group
🇺🇸Houston, Texas, United States
Texas Diab & Endo, P.A.
🇺🇸Round Rock, Texas, United States
Clinical Trials of Texas, LLC
🇺🇸San Antonio, Texas, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States
Rainier Clin Res Ctr Inc
🇺🇸Renton, Washington, United States
STAT Research
🇦🇷Buenos Aires, Argentina
Centro de Investigación Clínica
🇦🇷Caba, Argentina
Medical Center of Diabetes and Nutrition
🇦🇷Caba, Argentina
Instituto de Clínica Médica y Diabetes
🇦🇷Mendoza, Argentina
Universitätsklinik für Innere Medizin Graz
🇦🇹Graz, Austria
Universitätsklinik für Innere Medizin
🇦🇹Graz, Austria
Barmh. Brüder Linz, Konventspital
🇦🇹Linz, Austria
Gesundheitszentrum Hetzendorf
🇦🇹Wien, Austria
Hanusch-Krankenhaus, Wien
🇦🇹Wien, Austria
Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV
🇧🇷Curitiba, Parana, Brazil
Centro de Diabetes Curitiba
🇧🇷Curitiba, Parana, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
CPQuali Pesquisa Clínica Ltda
🇧🇷São Paulo, Sao Paulo, Brazil
Commonwealth Medical Clinic
🇨🇦Mount Pearl, Newfoundland and Labrador, Canada
Eastern Health Authority
🇨🇦St. Johns, Newfoundland and Labrador, Canada
LMC Diabetes & Endocrinology (Barrie)
🇨🇦Barrie, Ontario, Canada
LMC ClinRsrh Inc.Brampton
🇨🇦Brampton, Ontario, Canada
LMC (Thornhill)
🇨🇦Concord, Ontario, Canada
LMC Endo Ctr (Etobicoke) Ltd
🇨🇦Etobicoke, Ontario, Canada
Western Univ. Cnt for Studies in Fam Med
🇨🇦London, Ontario, Canada
LMC Research Inc. Ottawa
🇨🇦Nepean, Ontario, Canada
Bluewater Clin Res Group,Inc
🇨🇦Sarnia, Ontario, Canada
Centricity Research LMC
🇨🇦Toronto, Ontario, Canada
Dr. Anil K Gupta Medicine Professional Corporation
🇨🇦Toronto, Ontario, Canada
ViaCar Recherche Clinique Inc
🇨🇦Brossard, Quebec, Canada
Clinique de Recherche Medpharmgene Inc.
🇨🇦Montreal, Quebec, Canada
LMC Clin Rsrch Inc. (Montreal)
🇨🇦Saint-Laurent, Quebec, Canada
Diex Recherche Victoriaville
🇨🇦Victoriaville, Quebec, Canada