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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04770532
Other study ID # NN1436-4478
Secondary ID U1111-1247-49452
Status Completed
Phase Phase 3
First received
Last updated
Start date March 5, 2021
Est. completion date March 1, 2022

Study information

Verified date May 2023
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided by chance. The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 8 months. Participants will have 17 clinic visits and 13 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. Participants will be asked to wear a sensor that measures their blood sugar all the time in 3 periods for a total of 13 weeks (about 3 months) during the study. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Recruitment information / eligibility

Status Completed
Enrollment 526
Est. completion date March 1, 2022
Est. primary completion date January 27, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Male or female aged above or equal to 18 years at the time of signing informed consent. - Diagnosed with T2D greater than or equal to 180 days prior to the day of screening. - HbA1c from 7.0-10.0% (53.0 85.8 mmol/mol) both inclusive at screening confirmed by central laboratory analysis. - Treated with once daily or twice daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL): greater than or equal to 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to screening: - Metformin - Sulfonylureas - Meglitinides (glinides) - DPP-4 inhibitors - SGLT2 inhibitors - Thiazolidinediones - Alpha-glucosidase inhibitors - Oral combination products (for the allowed individual oral anti-diabetic drugs) - Oral or injectable GLP-1-receptor agonists - Body mass index (BMI) below or equal to 40.0 kg/m^2. Exclusion Criteria: - 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 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


Related Conditions & MeSH terms


Intervention

Drug:
Insulin degludec
Participants will receive subcutaneous (s.c.) injections of insulin degludec once daily for 26 weeks
Insulin Icodec
Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 26 weeks

Locations

Country Name City State
Bulgaria Novo Nordisk Investigational Site Kyustendil
Bulgaria Novo Nordisk Investigational Site Plovdiv
Bulgaria Novo Nordisk Investigational Site Ruse
Bulgaria Novo Nordisk Investigational Site Sofia
Germany Novo Nordisk Investigational Site Essen
Germany Novo Nordisk Investigational Site Hamburg
Germany Novo Nordisk Investigational Site Hohenmölsen
Germany Novo Nordisk Investigational Site Münster
Germany Novo Nordisk Investigational Site Rehlingen-Siersburg
Germany Novo Nordisk Investigational Site Stuttgart
Germany Novo Nordisk Investigational Site Stuttgart
Japan Novo Nordisk Investigational Site Chiba
Japan Novo Nordisk Investigational Site Chigasaki-shi, Kanagawa Kanagawa, Japan
Japan Novo Nordisk Investigational Site Fukuoka-shi, Fukuoka
Japan Novo Nordisk Investigational Site Ibaraki
Japan Novo Nordisk Investigational Site Miyazaki-shi Miyazaki, Japan
Japan Novo Nordisk Investigational Site Sapporo-shi, Hokkaido
Japan Novo Nordisk Investigational Site Tochigi
Japan Novo Nordisk Investigational Site Tokyo
Japan Novo Nordisk Investigational Site Ushiku-shi, Ibaraki
Korea, Republic of Novo Nordisk Investigational Site Gyeonggi-do
Korea, Republic of Novo Nordisk Investigational Site Seoul
Korea, Republic of Novo Nordisk Investigational Site Seoul
Korea, Republic of Novo Nordisk Investigational Site Seoul
Korea, Republic of Novo Nordisk Investigational Site Seoul
Korea, Republic of Novo Nordisk Investigational Site Seoul
Poland Novo Nordisk Investigational Site Lodz
Poland Novo Nordisk Investigational Site Poznan
Poland Novo Nordisk Investigational Site Warszawa
Portugal Novo Nordisk Investigational Site Almada
Portugal Novo Nordisk Investigational Site Lisboa
Portugal Novo Nordisk Investigational Site Matosinhos
Portugal Novo Nordisk Investigational Site Porto
Portugal Novo Nordisk Investigational Site Porto
Portugal Novo Nordisk Investigational Site Vila Nova de Gaia
South Africa Novo Nordisk Investigational Site Bloemfontein Free State
South Africa Novo Nordisk Investigational Site Durban KwaZulu-Natal
South Africa Novo Nordisk Investigational Site Johannesburg Gauteng
South Africa Novo Nordisk Investigational Site Johannesburg Gauteng
South Africa Novo Nordisk Investigational Site Johannesburg Gauteng
South Africa Novo Nordisk Investigational Site Port Elizabeth Eastern Cape
Ukraine Novo Nordisk Investigational Site Dnipro
Ukraine Novo Nordisk Investigational Site Kyiv
Ukraine Novo Nordisk Investigational Site Kyiv
Ukraine Novo Nordisk Investigational Site Ternopil
United States Novo Nordisk Investigational Site Albany New York
United States Novo Nordisk Investigational Site Amarillo Texas
United States Novo Nordisk Investigational Site Buena Park California
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Fort Worth Texas
United States Novo Nordisk Investigational Site Fresno California
United States Novo Nordisk Investigational Site Greensboro North Carolina
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site La Jolla California
United States Novo Nordisk Investigational Site Lincoln California
United States Novo Nordisk Investigational Site New Orleans Louisiana
United States Novo Nordisk Investigational Site Northridge California
United States Novo Nordisk Investigational Site Ocala Florida
United States Novo Nordisk Investigational Site Olympia Washington
United States Novo Nordisk Investigational Site Palm Springs California
United States Novo Nordisk Investigational Site Pembroke Pines Florida
United States Novo Nordisk Investigational Site Rockville Maryland
United States Novo Nordisk Investigational Site Roswell Georgia
United States Novo Nordisk Investigational Site San Antonio Texas
United States Novo Nordisk Investigational Site Slidell Louisiana
United States Novo Nordisk Investigational Site Sugar Land Texas
United States Novo Nordisk Investigational Site Valparaiso Indiana
United States Novo Nordisk Investigational Site Waco Texas
United States Novo Nordisk Investigational Site Walnut Creek California
United States Novo Nordisk Investigational Site Waltham Massachusetts
United States Novo Nordisk Investigational Site Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Bulgaria,  Germany,  Japan,  Korea, Republic of,  Poland,  Portugal,  South Africa,  Ukraine, 

References & Publications (2)

Philis-Tsimikas A, Asong M, Franek E, Jia T, Rosenstock J, Stachlewska K, Watada H, Kellerer M. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, r — View Citation

Philis-Tsimikas A, Bajaj HS, Begtrup K, Cailleteau R, Gowda A, Lingvay I, Mathieu C, Russell-Jones D, Rosenstock J. Rationale and design of the phase 3a development programme (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes. Diabe — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in HbA1c (glycated haemoglobin) %-point From baseline week 0 (V2) to week 26 (V28)
Secondary Change in fasting plasma glucose (FPG) mmol/L From baseline week 0 (V2) to week 26 (V28)
Secondary Time in target-range 3.9-10.0 mmol/L (70-180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 % of readings From week 22 (V24) to week 26 (V28)
Secondary Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction Score 0-36 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment From baseline week 0 (V2) to week 26 (V28)
Secondary Number of severe hypoglycaemic episodes (level 3) Number of episodes From baseline week 0 (V2) to week 31 (V30)
Secondary Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) Number of episodes From baseline week 0 (V2) to week 31 (V30)
Secondary Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) Number of episodes From baseline week 0 (V2) to week 31 (V30)
Secondary Time spent below 3.0 mmol/L (54 mg/dL) Using continuous glucose monitoring (CGM) system, Dexcom G6 % of readings From week 22 (V24) to week 26 (V28)
Secondary Time spent above 10 mmol/L (180 mg/dL) Using continuous glucose monitoring (CGM) system, Dexcom G6 % of readings From week 22 (V24) to week 26 (V28)
Secondary Mean weekly insulin dose U From week 24 (V26) to week 26 (V28)
Secondary Change in body weight kg From baseline week 0 (V2) to week 26 (V28)
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