ONWARDS 1: A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04460885
• Collaborator: (none)
• Enrollment: 984
• Locations: 150
• Arms: 2
• Anticipated Duration (Months): 24.1
• Patients Per Site: 6.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (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 glargine 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 glargine 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 1 ½ years. Participants will have 37 clinic visits and 26 phone calls with the study doctor. At 11 clinic visits participant will have blood samples taken. At 8 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 the blood sugar all the time in 5 periods of about one month during the study (about 5 months in total). 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 icodec; Drug: Insulin glargine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 984 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A 78-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Treatment, in Insulin naïve Subjects With Type 2 Diabetes
• Actual Study Start Date: Nov 25, 2020
• Actual Primary Completion Date: Apr 29, 2022
• Anticipated Study Completion Date: Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Insulin icodec Insulin icodec + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic 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 78 weeks.
Active Comparator: Insulin glargine Insulin glargine + non-insulin anti-diabetic drugs. The pre-trial non-insulin anti-diabetic background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period	Drug: Insulin glargine; Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 78 weeks

Outcome Measures

Primary Outcome Measures

1. Change in HbA1c [From baseline week 0 (V2) to week 52 (V46)]

   %-point

Secondary Outcome Measures

1. Time in target range 3.9-10.0 mmol/L (70-180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 [From week 48 (V42) to week 52 (V46)]

   % of readings

2. Change in fasting plasma glucose (FPG) [From baseline week 0 (V2) to week 52 (V46)]

   mmol/L

3. Number of severe hypoglycaemic episodes (level 3) [From baseline week 0 (V2) to week 52 (V46)]

   Number of episodes

4. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter) [From baseline week 0 (V2) to week 52 (V46)]

   Number of episodes

5. 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 (V2) to week 52 (V46)]

   Number of episodes

6. Number of severe hypoglycaemic episodes (level 3) [From baseline week 0 (V2) to week 83 (V63)]

   Number of episodes

7. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by BG meter) [From baseline week 0 (V2) to week 83 (V63)]

   Number of episodes

8. 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 (V2) to week 83 (V63)]

   Number of episodes

9. Mean weekly insulin dose [From week 50 (V44) to week 52 (V46)]

   U

10. Change in body weight [From baseline week 0 (V2) to week 52 (V46)]

    kg

11. Time spent < 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 [From week 48 (V42) to week 52 (V46)]

    % of readings

12. Time spent > 10 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6 [From week 48 (V42) to week 52 (V46)]

    % of readings

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 above or equal to 18 years at the time of signing informed consent.

• Diagnosed with type 2 diabetes mellitus (T2D) 180 days or more prior to the day of screening.

• HbA1c 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.

• Stable daily dose(s) 90 days or more prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s): a. Any metformin formulations at least or greater than 1500 mg or maximum tolerated or effective dose.

1. Any metformin combination formulations equal to or above 1500 mg or maximum tolerated or effective dose. c. Any of the following oral anti-diabetic drug classes including combinations ((equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose): Sulfonylureas, Meglitinides (glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2 (SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral anti-diabetic drugs), Oral or injectable glucagon-like peptide 1 (GLP-1) receptor agonists

• Body mass index (BMI) equal to or below 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	Birmingham	Alabama	United States	35294
2	Novo Nordisk Investigational Site	Guntersville	Alabama	United States	35976
3	Novo Nordisk Investigational Site	Buena Park	California	United States	90620
4	Novo Nordisk Investigational Site	Fresno	California	United States	93720
5	Novo Nordisk Investigational Site	Lancaster	California	United States	93534
6	Novo Nordisk Investigational Site	Palm Springs	California	United States	92262
7	Novo Nordisk Investigational Site	Ventura	California	United States	93003
8	Novo Nordisk Investigational Site	Waterbury	Connecticut	United States	06708
9	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32216
10	Novo Nordisk Investigational Site	New Port Richey	Florida	United States	34652
11	Novo Nordisk Investigational Site	Orlando	Florida	United States	32825
12	Novo Nordisk Investigational Site	Palm Harbor	Florida	United States	34684-3609
13	Novo Nordisk Investigational Site	West Palm Beach	Florida	United States	33401
14	Novo Nordisk Investigational Site	Winter Haven	Florida	United States	33880
15	Novo Nordisk Investigational Site	Lawrenceville	Georgia	United States	30046
16	Novo Nordisk Investigational Site	Honolulu	Hawaii	United States	96814
17	Novo Nordisk Investigational Site	Chicago	Illinois	United States	60607
18	Novo Nordisk Investigational Site	Gurnee	Illinois	United States	60031
19	Novo Nordisk Investigational Site	West Des Moines	Iowa	United States	50265
20	Novo Nordisk Investigational Site	Topeka	Kansas	United States	66606
21	Novo Nordisk Investigational Site	Paducah	Kentucky	United States	42001
22	Novo Nordisk Investigational Site	Hyattsville	Maryland	United States	20782
23	Novo Nordisk Investigational Site	Rockville	Maryland	United States	20852
24	Novo Nordisk Investigational Site	Troy	Michigan	United States	48098
25	Novo Nordisk Investigational Site	Omaha	Nebraska	United States	68114
26	Novo Nordisk Investigational Site	Omaha	Nebraska	United States	68198-3020
27	Novo Nordisk Investigational Site	Nashua	New Hampshire	United States	03060
28	Novo Nordisk Investigational Site	Albuquerque	New Mexico	United States	87102
29	Novo Nordisk Investigational Site	Brooklyn	New York	United States	11215
30	Novo Nordisk Investigational Site	New York	New York	United States	10016
31	Novo Nordisk Investigational Site	West Seneca	New York	United States	14224
32	Novo Nordisk Investigational Site	Greenville	North Carolina	United States	27834
33	Novo Nordisk Investigational Site	Raleigh	North Carolina	United States	27609
34	Novo Nordisk Investigational Site	Wilmington	North Carolina	United States	28401
35	Novo Nordisk Investigational Site	Fargo	North Dakota	United States	58104
36	Novo Nordisk Investigational Site	Canton	Ohio	United States	44718
37	Novo Nordisk Investigational Site	Dayton	Ohio	United States	45439
38	Novo Nordisk Investigational Site	Franklin	Ohio	United States	45005
39	Novo Nordisk Investigational Site	Norman	Oklahoma	United States	73069
40	Novo Nordisk Investigational Site	Murrells Inlet	South Carolina	United States	29576
41	Novo Nordisk Investigational Site	Simpsonville	South Carolina	United States	29681-1538
42	Novo Nordisk Investigational Site	Kingsport	Tennessee	United States	37660
43	Novo Nordisk Investigational Site	Austin	Texas	United States	78731
44	Novo Nordisk Investigational Site	Dallas	Texas	United States	75230
45	Novo Nordisk Investigational Site	Dallas	Texas	United States	75390-9302
46	Novo Nordisk Investigational Site	Houston	Texas	United States	77024
47	Novo Nordisk Investigational Site	Houston	Texas	United States	77074
48	Novo Nordisk Investigational Site	Lampasas	Texas	United States	76550
49	Novo Nordisk Investigational Site	Live Oak	Texas	United States	78233
50	Novo Nordisk Investigational Site	Round Rock	Texas	United States	78681
51	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78229
52	Novo Nordisk Investigational Site	Sugar Land	Texas	United States	77478
53	Novo Nordisk Investigational Site	Bountiful	Utah	United States	84010
54	Novo Nordisk Investigational Site	Ogden	Utah	United States	84405
55	Novo Nordisk Investigational Site	Saint George	Utah	United States	84790
56	Novo Nordisk Investigational Site	Newport News	Virginia	United States	23606
57	Novo Nordisk Investigational Site	Renton	Washington	United States	98057
58	Novo Nordisk Investigational Site	Karlovac		Croatia	47000
59	Novo Nordisk Investigational Site	Osijek		Croatia	31000
60	Novo Nordisk Investigational Site	Rijeka		Croatia	51000
61	Novo Nordisk Investigational Site	Varazdin		Croatia	42 000
62	Novo Nordisk Investigational Site	Hyderabad	Andhra Pradesh	India	500072
63	Novo Nordisk Investigational Site	Rohtak	Haryana	India	124001
64	Novo Nordisk Investigational Site	Indore	Madhya Pradesh	India	452010
65	Novo Nordisk Investigational Site	Mumbai	Maharashtra	India	400008
66	Novo Nordisk Investigational Site	Pune	Maharashtra	India	411021
67	Novo Nordisk Investigational Site	New Dehli	New Delhi	India	110029
68	Novo Nordisk Investigational Site	Chennai	Tamil Nadu	India	600086
69	Novo Nordisk Investigational Site	Vellore	Tamil Nadu	India	632004
70	Novo Nordisk Investigational Site	Hyderabad	Telengana	India	500003
71	Novo Nordisk Investigational Site	Hyderbad	Telengana	India	500 012
72	Novo Nordisk Investigational Site	Holon		Israel	58100
73	Novo Nordisk Investigational Site	Jerusalem		Israel	91120
74	Novo Nordisk Investigational Site	Kfar Saba		Israel	44281
75	Novo Nordisk Investigational Site	Petach Tikva		Israel	49100
76	Novo Nordisk Investigational Site	Rehovot		Israel	76100
77	Novo Nordisk Investigational Site	Bergamo		Italy	24127
78	Novo Nordisk Investigational Site	Catanzaro		Italy	88100
79	Novo Nordisk Investigational Site	Milano		Italy	20122
80	Novo Nordisk Investigational Site	Palermo		Italy	90127
81	Novo Nordisk Investigational Site	Roma		Italy	00161
82	Novo Nordisk Investigational Site	Bunkyo-ku, Tokyo		Japan	113-8655
83	Novo Nordisk Investigational Site	Chiba		Japan	261-0004
84	Novo Nordisk Investigational Site	Chigasaki-shi, Kanagawa		Japan	253-0044
85	Novo Nordisk Investigational Site	Fukuoka-shi, Fukuoka		Japan	819-0006
86	Novo Nordisk Investigational Site	Ibaraki		Japan	311-0113
87	Novo Nordisk Investigational Site	Kitakyusyu-shi, Fukuoka		Japan	800-0222
88	Novo Nordisk Investigational Site	Minato-ku, Tokyo		Japan	105-8470
89	Novo Nordisk Investigational Site	Miyagi		Japan	983-0039
90	Novo Nordisk Investigational Site	Miyazaki		Japan	880-0034
91	Novo Nordisk Investigational Site	Saitama		Japan	336-0967
92	Novo Nordisk Investigational Site	Shimotsuke-shi, Tochigi		Japan	329-0433
93	Novo Nordisk Investigational Site	Tochigi		Japan	323-0022
94	Novo Nordisk Investigational Site	Ushiku-shi, Ibaraki		Japan	300-1207
95	Novo Nordisk Investigational Site	Guadalajara	Jalisco	Mexico	64460
96	Novo Nordisk Investigational Site	Mexico City	México, D.F.	Mexico	06700
97	Novo Nordisk Investigational Site	Monterrey	Nuevo León	Mexico	64460
98	Novo Nordisk Investigational Site	Hermosillo	Sonora	Mexico	83280
99	Novo Nordisk Investigational Site	Bialystok		Poland	15-435
100	Novo Nordisk Investigational Site	Gorzow Wielkopolski		Poland	66-400
101	Novo Nordisk Investigational Site	Lublin		Poland	20-044
102	Novo Nordisk Investigational Site	Lublin		Poland	20-538
103	Novo Nordisk Investigational Site	Radom		Poland	26-600
104	Novo Nordisk Investigational Site	Warsaw		Poland	00-465
105	Novo Nordisk Investigational Site	Wierzchoslawice		Poland	33-122
106	Novo Nordisk Investigational Site	Zabrze		Poland	41-800
107	Novo Nordisk Investigational Site	Bayamon		Puerto Rico	00961
108	Novo Nordisk Investigational Site	Manati		Puerto Rico	00674
109	Novo Nordisk Investigational Site	Kemerovo		Russian Federation	650066
110	Novo Nordisk Investigational Site	Moscow		Russian Federation	117292
111	Novo Nordisk Investigational Site	Moscow		Russian Federation	119435
112	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630099
113	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630117
114	Novo Nordisk Investigational Site	Penza		Russian Federation	440052
115	Novo Nordisk Investigational Site	Saint Petersburg		Russian Federation	194291
116	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	194156
117	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	194356
118	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	197110
119	Novo Nordisk Investigational Site	Saratov		Russian Federation	410039
120	Novo Nordisk Investigational Site	Tomsk		Russian Federation	634050
121	Novo Nordisk Investigational Site	Voronezh		Russian Federation	394018
122	Novo Nordisk Investigational Site	Yoshkar-Ola		Russian Federation	424004
123	Novo Nordisk Investigational Site	Bratislava		Slovakia	821 02
124	Novo Nordisk Investigational Site	Bratislava		Slovakia	84102
125	Novo Nordisk Investigational Site	Bratislava		Slovakia	851 01
126	Novo Nordisk Investigational Site	Malacky		Slovakia	901 01
127	Novo Nordisk Investigational Site	Malacky		Slovakia	90101
128	Novo Nordisk Investigational Site	Moldava nad Bodvou		Slovakia	045 01
129	Novo Nordisk Investigational Site	Sahy		Slovakia	93601
130	Novo Nordisk Investigational Site	Trebisov		Slovakia	07501
131	Novo Nordisk Investigational Site	La Coruña		Spain	15006
132	Novo Nordisk Investigational Site	La Roca del Vallés		Spain	08430
133	Novo Nordisk Investigational Site	Madrid		Spain	28006
134	Novo Nordisk Investigational Site	Madrid		Spain	28020
135	Novo Nordisk Investigational Site	Pozuelo de Alarcon		Spain	28223
136	Novo Nordisk Investigational Site	Blackpool		United Kingdom	FY3 7EN
137	Novo Nordisk Investigational Site	Bollington		United Kingdom	SK10 5JH
138	Novo Nordisk Investigational Site	Bradford-on-Avon		United Kingdom	BA15 1DQ
139	Novo Nordisk Investigational Site	Bristol		United Kingdom	BS10 5NB
140	Novo Nordisk Investigational Site	Cambridge		United Kingdom	CB2 0QQ
141	Novo Nordisk Investigational Site	Chester		United Kingdom	CH2 1UL
142	Novo Nordisk Investigational Site	Dorset		United Kingdom	BH16 5PW
143	Novo Nordisk Investigational Site	Dundee		United Kingdom	DD1 9SY
144	Novo Nordisk Investigational Site	Edinburgh		United Kingdom	EH4 2XU
145	Novo Nordisk Investigational Site	High Wycombe		United Kingdom	HP11 2TT
146	Novo Nordisk Investigational Site	Hinckley		United Kingdom	LE10 2SE
147	Novo Nordisk Investigational Site	Soham		United Kingdom	CB7 5JD
148	Novo Nordisk Investigational Site	Swansea		United Kingdom	SA2 8PP
149	Novo Nordisk Investigational Site	Truro		United Kingdom	TR1 3LJ
150	Novo Nordisk Investigational Site	Wellingborough		United Kingdom	NN8 4RW

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: NCT04460885
• Other Study ID Numbers: NN1436-4477; U1111-1247-3878; 2020-000442-34
• First Posted: Jul 8, 2020
• Last Update Posted: May 10, 2022
• Last Verified: May 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 2; Insulin; Insulin, Globin Zinc; Insulin Glargine

Study Results

No Results Posted as of May 10, 2022