ONWARDS 2: A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT04770532

Collaborator

(none)

526

Enrollment

Locations

Arms

11.9

Actual Duration (Months)

7.3

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Insulin degludec Drug: Insulin Icodec	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

526 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec, Both With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes Treated With Basal Insulin

Actual Study Start Date :

Mar 5, 2021

Actual Primary Completion Date :

Jan 27, 2022

Actual Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Insulin icodec Insulin icodeg + non-insulin anti-diabetic drugs. Pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which must be discontinued at randomisation. The background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period.	Drug: Insulin Icodec Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 26 weeks
Active Comparator: Insulin degludec Insulin degludec + non-insulin anti-diabetic drugs. Pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which must be discontinued at randomisation. The background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period.	Drug: Insulin degludec Participants will receive subcutaneous (s.c.) injections of insulin degludec once daily for 26 weeks

Arm

Intervention/Treatment

Experimental: Insulin icodec

Insulin icodeg + non-insulin anti-diabetic drugs. Pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which must be discontinued at randomisation. The background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period.

Drug: Insulin Icodec

Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 26 weeks

Active Comparator: Insulin degludec

Insulin degludec + non-insulin anti-diabetic drugs. Pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which must be discontinued at randomisation. The background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period.

Drug: Insulin degludec

Participants will receive subcutaneous (s.c.) injections of insulin degludec once daily for 26 weeks

Outcome Measures

Primary Outcome Measures

Change in HbA1c (glycated haemoglobin) [From baseline week 0 (V2) to week 26 (V28)]
%-point

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Buena Park	California	United States	90620
2	Novo Nordisk Investigational Site	Fresno	California	United States	93720
3	Novo Nordisk Investigational Site	La Jolla	California	United States	92037
4	Novo Nordisk Investigational Site	Lincoln	California	United States	95648
5	Novo Nordisk Investigational Site	Northridge	California	United States	91325
6	Novo Nordisk Investigational Site	Palm Springs	California	United States	92262
7	Novo Nordisk Investigational Site	Walnut Creek	California	United States	94598
8	Novo Nordisk Investigational Site	Ocala	Florida	United States	34470
9	Novo Nordisk Investigational Site	Pembroke Pines	Florida	United States	33027
10	Novo Nordisk Investigational Site	Roswell	Georgia	United States	30076
11	Novo Nordisk Investigational Site	Valparaiso	Indiana	United States	46383
12	Novo Nordisk Investigational Site	New Orleans	Louisiana	United States	70119
13	Novo Nordisk Investigational Site	Slidell	Louisiana	United States	70461-4231
14	Novo Nordisk Investigational Site	Rockville	Maryland	United States	20852
15	Novo Nordisk Investigational Site	Waltham	Massachusetts	United States	02453
16	Novo Nordisk Investigational Site	Albany	New York	United States	12203
17	Novo Nordisk Investigational Site	Greensboro	North Carolina	United States	27408
18	Novo Nordisk Investigational Site	Wilmington	North Carolina	United States	28401
19	Novo Nordisk Investigational Site	Amarillo	Texas	United States	79106
20	Novo Nordisk Investigational Site	Dallas	Texas	United States	75230
21	Novo Nordisk Investigational Site	Fort Worth	Texas	United States	76132
22	Novo Nordisk Investigational Site	Houston	Texas	United States	77079
23	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78215
24	Novo Nordisk Investigational Site	Sugar Land	Texas	United States	77478
25	Novo Nordisk Investigational Site	Waco	Texas	United States	76708
26	Novo Nordisk Investigational Site	Olympia	Washington	United States	98502
27	Novo Nordisk Investigational Site	Kyustendil		Bulgaria	2500
28	Novo Nordisk Investigational Site	Plovdiv		Bulgaria	4002
29	Novo Nordisk Investigational Site	Ruse		Bulgaria	7002
30	Novo Nordisk Investigational Site	Sofia		Bulgaria	1606
31	Novo Nordisk Investigational Site	Essen		Germany	45136
32	Novo Nordisk Investigational Site	Hamburg		Germany	22607
33	Novo Nordisk Investigational Site	Hohenmölsen		Germany	06679
34	Novo Nordisk Investigational Site	Münster		Germany	48145
35	Novo Nordisk Investigational Site	Rehlingen-Siersburg		Germany	66780
36	Novo Nordisk Investigational Site	Stuttgart		Germany	70199
37	Novo Nordisk Investigational Site	Stuttgart		Germany	70378
38	Novo Nordisk Investigational Site	Chiba		Japan	261-0004
39	Novo Nordisk Investigational Site	Chigasaki-shi, Kanagawa		Japan	253-0044
40	Novo Nordisk Investigational Site	Fukuoka-shi, Fukuoka		Japan	819-0006
41	Novo Nordisk Investigational Site	Ibaraki		Japan	311-0113
42	Novo Nordisk Investigational Site	Miyazaki		Japan	880-0034
43	Novo Nordisk Investigational Site	Sapporo-shi, Hokkaido		Japan	060-0001
44	Novo Nordisk Investigational Site	Tochigi		Japan	323-0022
45	Novo Nordisk Investigational Site	Tokyo		Japan	113-8431
46	Novo Nordisk Investigational Site	Ushiku-shi, Ibaraki		Japan	300-1207
47	Novo Nordisk Investigational Site	Gyeonggi-do		Korea, Republic of	13620
48	Novo Nordisk Investigational Site	Seoul		Korea, Republic of	02841
49	Novo Nordisk Investigational Site	Seoul		Korea, Republic of	03080
50	Novo Nordisk Investigational Site	Seoul		Korea, Republic of	03181
51	Novo Nordisk Investigational Site	Seoul		Korea, Republic of	03722
52	Novo Nordisk Investigational Site	Seoul		Korea, Republic of	139-827
53	Novo Nordisk Investigational Site	Suwon-si, Gyeonggi-do		Korea, Republic of	16247
54	Novo Nordisk Investigational Site	Lodz		Poland	90-242
55	Novo Nordisk Investigational Site	Poznan		Poland	60-821
56	Novo Nordisk Investigational Site	Warszawa		Poland	02-507
57	Novo Nordisk Investigational Site	Almada		Portugal	2805-267
58	Novo Nordisk Investigational Site	Lisboa		Portugal	1349-019
59	Novo Nordisk Investigational Site	Matosinhos		Portugal	4464-513
60	Novo Nordisk Investigational Site	Porto		Portugal	4099-001
61	Novo Nordisk Investigational Site	Porto		Portugal	4200-319
62	Novo Nordisk Investigational Site	Vila Nova de Gaia		Portugal	4400-346
63	Novo Nordisk Investigational Site	Port Elizabeth	Eastern Cape	South Africa	6045
64	Novo Nordisk Investigational Site	Bloemfontein	Free State	South Africa	9301
65	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	1827
66	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	2013
67	Novo Nordisk Investigational Site	Johannesburg	Gauteng	South Africa	2198
68	Novo Nordisk Investigational Site	Durban	KwaZulu-Natal	South Africa	4092
69	Novo Nordisk Investigational Site	Dnipro		Ukraine	49038
70	Novo Nordisk Investigational Site	Kyiv		Ukraine	04053
71	Novo Nordisk Investigational Site	Kyiv		Ukraine	04114
72	Novo Nordisk Investigational Site	Ternopil		Ukraine	46001

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT04770532

Other Study ID Numbers:

NN1436-4478
U1111-1247-4945
2020-000454-10

First Posted:

Feb 25, 2021

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Insulin

Insulin, Globin Zinc

Study Results

No Results Posted as of Mar 31, 2022