A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04848480
• Collaborator: (none)
• Enrollment: 580
• Locations: 98
• Arms: 2
• Anticipated Duration (Months): 19.1
• Patients Per Site: 5.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study compares insulin icodec (a new insulin) to insulin degludec (an insulin already available on the market) in people with type 1 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 at random. Participants will also get a mealtime insulin.

The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach.

The study will last for about 1 year and 2 months. Participants will have 28 clinic visits and 28 phone calls with the study doctor. At 11 clinic visits participants will have blood samples taken.

At 6 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 your blood sugar all the time. Participants will be asked to wear it for a total of 57 weeks (around 1 year).

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 1	Drug: insulin icodec; Drug: insulin degludec; Drug: insulin aspart	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 580 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes. A 26-week, Randomised, Multicentre, Open-label, Active-controlled, Parallel Group, Two Armed, Treat-to-target Trial Investigating the Effect on Glycaemic Control and Safety of Treatment With Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec, Both in Combination With Insulin Aspart in Adults With Type 1 Diabetes, With a 26-week Extension Investigating Long Term Safety
• Actual Study Start Date: Apr 30, 2021
• Actual Primary Completion Date: Apr 28, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Insulin icodec + insulin aspart insulin icodec once a week in combination with 2-4 times daily injections of insulin aspart at meal times	Drug: insulin icodec; insulin icodec 700 units/mL, subcutaneously (under the skin), solution for injection once weekly; Drug: insulin aspart; insulin aspart 100 units/mL, subcutaneously (under the skin), solution for injection daily
Active Comparator: Insulin degludec + insulin aspart insulin degludec once a day in combination with 2-4 times daily injections of insulin aspart at meal times	Drug: insulin degludec; insulin degludec 100 units/mL, subcutaneously (under the skin), solution for injection once daily; Drug: insulin aspart; insulin aspart 100 units/mL, subcutaneously (under the skin), solution for injection daily

Outcome Measures

Primary Outcome Measures

1. Change in HbA1c (glycated haemoglobin) [From baseline (week 0) to week 26]

   %-point

Secondary Outcome Measures

1. Change in fasting plasma glucose (FPG) [From baseline (week 0) to week 26]

   mmol/L

2. Time in range 3.9-10.0 mmol/L (70-180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 [From week 22 to week 26]

   % of readings

3. Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction [From baseline (week 0) to week 26]

   Score 0-36 6 items scored on a scale of 0 to 6. The higher the score the greater the satisfaction with treatment

4. Change in HbA1c [From baseline (week 0) to week 52]

   %-point

5. Number of severe hypoglycaemic episodes (level 3) [From baseline (week 0) to week 26]

   Number of episodes

6. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) [From baseline (week 0) to week 26]

   Number of episodes

7. 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) to week 26]

   Number of episodes

8. Number of severe hypoglycaemic episodes (level 3) [From baseline (week 0) to week 57]

   Number of episodes

9. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) [From baseline (week 0) to week 57]

   Number of episodes

10. 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) to week 57]

    Number of episodes

11. Number of nocturnal 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) to week 26]

    Number of episodes

12. Number of nocturnal 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) to week 57]

    Number of episodes

13. Time spent below 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 [From week 22 to week 26]

    % of readings

14. Time spent greater than 10 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 [From week 22 to week 26]

    % of readings

15. Mean total weekly insulin dose [From week 24 to week 26]

    U

16. Mean total weekly insulin dose [From week 50 to week 52]

    U

17. Change in body weight [From baseline (week 0) to week 26]

    kg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female aged greater than or equal to 18 years at the time of signing informed consent.

• Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening.

• Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) greater than or equal to 1 year prior to the day of screening.

• HbA1c below10% at screening visit based on analysis from central laboratory.

Exclusion Criteria:

• Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.

• Chronic heart failure classified as 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Concord	California	United States	94520
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	La Mesa	California	United States	91942
5	Novo Nordisk Investigational Site	San Mateo	California	United States	94401
6	Novo Nordisk Investigational Site	Denver	Colorado	United States	80246
7	Novo Nordisk Investigational Site	Fleming Island	Florida	United States	32003
8	Novo Nordisk Investigational Site	Fort Lauderdale	Florida	United States	33312
9	Novo Nordisk Investigational Site	Port Charlotte	Florida	United States	33952
10	Novo Nordisk Investigational Site	Saint Augustine	Florida	United States	32080
11	Novo Nordisk Investigational Site	Lawrenceville	Georgia	United States	30046
12	Novo Nordisk Investigational Site	Roswell	Georgia	United States	30076
13	Novo Nordisk Investigational Site	Topeka	Kansas	United States	66606
14	Novo Nordisk Investigational Site	Rockville	Maryland	United States	20852
15	Novo Nordisk Investigational Site	Omaha	Nebraska	United States	68114
16	Novo Nordisk Investigational Site	Las Vegas	Nevada	United States	89148
17	Novo Nordisk Investigational Site	Nashua	New Hampshire	United States	03060
18	Novo Nordisk Investigational Site	Albany	New York	United States	12203
19	Novo Nordisk Investigational Site	Wilmington	North Carolina	United States	28401
20	Novo Nordisk Investigational Site	Greenville	South Carolina	United States	29605-4254
21	Novo Nordisk Investigational Site	Chattanooga	Tennessee	United States	37411
22	Novo Nordisk Investigational Site	Amarillo	Texas	United States	79106
23	Novo Nordisk Investigational Site	Austin	Texas	United States	78731
24	Novo Nordisk Investigational Site	Austin	Texas	United States	78749
25	Novo Nordisk Investigational Site	Dallas	Texas	United States	75230
26	Novo Nordisk Investigational Site	Dallas	Texas	United States	75231
27	Novo Nordisk Investigational Site	Houston	Texas	United States	77079
28	Novo Nordisk Investigational Site	Live Oak	Texas	United States	78233
29	Novo Nordisk Investigational Site	Renton	Washington	United States	98057
30	Novo Nordisk Investigational Site	Graz		Austria	8036
31	Novo Nordisk Investigational Site	Innsbruck		Austria	6020
32	Novo Nordisk Investigational Site	Saint Stefan		Austria	8511
33	Novo Nordisk Investigational Site	Wien		Austria	1030
34	Novo Nordisk Investigational Site	Wien		Austria	1090
35	Novo Nordisk Investigational Site	Wien		Austria	1130
36	Novo Nordisk Investigational Site	Winnipeg	Manitoba	Canada	R3C 0N2
37	Novo Nordisk Investigational Site	St. Johns	Newfoundland and Labrador	Canada	A1B 3V6
38	Novo Nordisk Investigational Site	Halifax	Nova Scotia	Canada	B3H 1V7
39	Novo Nordisk Investigational Site	Toronto	Ontario	Canada	M4G 3E8
40	Novo Nordisk Investigational Site	Laval	Quebec	Canada	H7T 2P5
41	Novo Nordisk Investigational Site	Quebec		Canada	G1V 4G2
42	Novo Nordisk Investigational Site	Berlin		Germany	13597
43	Novo Nordisk Investigational Site	Essen		Germany	45136
44	Novo Nordisk Investigational Site	Falkensee		Germany	14612
45	Novo Nordisk Investigational Site	Ludwigshafen		Germany	67059
46	Novo Nordisk Investigational Site	Lübeck		Germany	23562
47	Novo Nordisk Investigational Site	Münster		Germany	48145
48	Novo Nordisk Investigational Site	Oldenburg I. Holst		Germany	23758
49	Novo Nordisk Investigational Site	Saint Ingbert-Oberwürzbach		Germany	66386
50	Novo Nordisk Investigational Site	Kozhikode	Kerala	India	673017
51	Novo Nordisk Investigational Site	New Dehli	New Delhi	India	110029
52	Novo Nordisk Investigational Site	Hyderabad		India	600034
53	Novo Nordisk Investigational Site	Catanzaro		Italy	88100
54	Novo Nordisk Investigational Site	Milano		Italy	20132
55	Novo Nordisk Investigational Site	Perugia		Italy	06129
56	Novo Nordisk Investigational Site	Roma		Italy	00161
57	Novo Nordisk Investigational Site	Rome		Italy	00168
58	Novo Nordisk Investigational Site	Chuo-ku, Tokyo		Japan	103-0002
59	Novo Nordisk Investigational Site	Fukushima		Japan	963-8851
60	Novo Nordisk Investigational Site	Hokkaido		Japan	060-0062
61	Novo Nordisk Investigational Site	Kumamoto		Japan	862-0976
62	Novo Nordisk Investigational Site	Sapporo-shi, Hokkaido		Japan	060-0001
63	Novo Nordisk Investigational Site	Tokyo		Japan	162 8666
64	Novo Nordisk Investigational Site	Apeldoorn		Netherlands	7334 DZ
65	Novo Nordisk Investigational Site	Arnhem		Netherlands	6815 AD
66	Novo Nordisk Investigational Site	Eindhoven		Netherlands	5631 BM
67	Novo Nordisk Investigational Site	Hoogeveen		Netherlands	7909 AA
68	Novo Nordisk Investigational Site	Rotterdam		Netherlands	3083 AN
69	Novo Nordisk Investigational Site	Utrecht		Netherlands	3584 CX
70	Novo Nordisk Investigational Site	Moscow		Russian Federation	117292
71	Novo Nordisk Investigational Site	Moscow		Russian Federation	119034
72	Novo Nordisk Investigational Site	Moscow		Russian Federation	123448
73	Novo Nordisk Investigational Site	Saint Petersburg		Russian Federation	191014
74	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	194354
75	Novo Nordisk Investigational Site	Saratov		Russian Federation	410031
76	Novo Nordisk Investigational Site	Saratov		Russian Federation	410053
77	Novo Nordisk Investigational Site	St. Petersburg		Russian Federation	194354
78	Novo Nordisk Investigational Site	Voronezh		Russian Federation	394018
79	Novo Nordisk Investigational Site	Yaroslavl		Russian Federation	150062
80	Novo Nordisk Investigational Site	Barcelona		Spain	08036
81	Novo Nordisk Investigational Site	Málaga		Spain	29010
82	Novo Nordisk Investigational Site	Oviedo		Spain	33011
83	Novo Nordisk Investigational Site	Sevilla		Spain	41003
84	Novo Nordisk Investigational Site	Adana		Turkey	01130
85	Novo Nordisk Investigational Site	Aydin		Turkey	09010
86	Novo Nordisk Investigational Site	Istanbul		Turkey	34371
87	Novo Nordisk Investigational Site	Istanbul		Turkey	34400
88	Novo Nordisk Investigational Site	Istanbul		Turkey	34668
89	Novo Nordisk Investigational Site	Kayseri		Turkey	38039
90	Novo Nordisk Investigational Site	Malatya		Turkey	44280
91	Novo Nordisk Investigational Site	Bristol		United Kingdom	BS10 5NB
92	Novo Nordisk Investigational Site	Cambridge		United Kingdom	CB2 0QQ
93	Novo Nordisk Investigational Site	Derby		United Kingdom	DE1 2QY
94	Novo Nordisk Investigational Site	Edinburgh		United Kingdom	EH4 2XU
95	Novo Nordisk Investigational Site	Guildford		United Kingdom	GU2 7XX
96	Novo Nordisk Investigational Site	Oxford		United Kingdom	OX3 7LE
97	Novo Nordisk Investigational Site	Stevenage		United Kingdom	SG1 4AB
98	Novo Nordisk Investigational Site	Swansea		United Kingdom	SA2 8PP

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Transparency (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: NCT04848480
• Other Study ID Numbers: NN1436-4625; U1111-1251-7315; 2020-002374-27
• First Posted: Apr 19, 2021
• Last Update Posted: Jun 7, 2022
• Last Verified: Jun 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: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin; Insulin, Globin Zinc; Insulin Aspart

Study Results

No Results Posted as of Jun 7, 2022