A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05144984
• Collaborator: (none)
• Enrollment: 495
• Locations: 96
• Arms: 10
• Anticipated Duration (Months): 14
• Patients Per Site: 5.2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes.

The study is being conducted to see how well semaglutide, in combination with different doses of NNC0480-0389, work to lower blood sugar levels. Results from this study will be used to select the doses of the two medicines for other studies.

Participants will either get:

Semaglutide (a medicine doctors can already prescribe for treatment of type 2 diabetes) in combination with NNC0480-0389 (a potential new medicine) or placebo (a 'dummy' medicine that looks like the medicines but without any medicine).

NNC0480-0389 alone, or semaglutide alone which treatment participant get is decided by chance.

Participant will need to take 2-3 injections once every week during the study. One injection will be with semaglutide or placebo and 1-2 injections will be with NNC0480-0389 or placebo.

Participant must inject the study medicines themself into the stomach, thigh, or upper arm.

The study will last for about 41weeks. Participant will have 20 clinic visits. Participant will have blood samples taken at all clinic visits. At 3 clinic visits, participant will also have an electrocardiogram (ECG). This is a test to check participants heart. Participant will have their eyes checked before or at the start of the study and at the end of the study.

Women can only take part in the study if they are not able to become pregnant

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: NNC0480-0389; Drug: Semaglutide; Drug: Placebo (NNC080-0389); Drug: Placebo (semaglutide)	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 495 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Investigation of the Safety and Efficacy of Semaglutide s.c. in Combination With NNC0480-0389 in Participants With Type 2 Diabetes - a Dose Finding Study
• Actual Study Start Date: Nov 29, 2021
• Anticipated Primary Completion Date: Oct 26, 2022
• Anticipated Study Completion Date: Jan 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 2.4 mg semaglutide + 2.4 mg NNC0480-0389 subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide.	Drug: NNC0480-0389; A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.; Drug: Semaglutide; A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.
Placebo Comparator: Placebo (semaglutide) + placebo ( 2.4 mg NNC0480-0389) subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).	Drug: Placebo (NNC080-0389); A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.; Drug: Placebo (semaglutide); A weekly dose of placebo (semaglutide). The study will last for about 41weeks.
Experimental: 2.4 mg semaglutide + 7.2 mg NNC0480-0389 subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide	Drug: NNC0480-0389; A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.; Drug: Semaglutide; A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.
Experimental: 2.4 mg semaglutide + 12.0 mg NNC0480-0389 subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide	Drug: NNC0480-0389; A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.; Drug: Semaglutide; A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.
Experimental: 2.4 mg semaglutide + 21.6 mg NNC0480-0389 subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. semaglutide	Drug: NNC0480-0389; A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.; Drug: Semaglutide; A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.
Experimental: NNC0480-0389 + placebo (semaglutide) subjects will receive once weekly subcutaneous (s.c., under the skin) dose of NNC0480-0389 co-administered with s.c. placebo (semaglutide)	Drug: NNC0480-0389; A weekly dose of NNC0480-0389, dose increased in each cohort. The study will last for about 41weeks.; Drug: Placebo (semaglutide); A weekly dose of placebo (semaglutide). The study will last for about 41weeks.
Placebo Comparator: Placebo (semaglutide) + placebo ( 7.2 mg NNC0480-0389) subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).	Drug: Placebo (NNC080-0389); A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.; Drug: Placebo (semaglutide); A weekly dose of placebo (semaglutide). The study will last for about 41weeks.
Placebo Comparator: Placebo (semaglutide) + placebo ( 12.0 mg NNC0480-0389) subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).	Drug: Placebo (NNC080-0389); A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.; Drug: Placebo (semaglutide); A weekly dose of placebo (semaglutide). The study will last for about 41weeks.
Placebo Comparator: Placebo (semaglutide) + placebo ( 21.6 mg NNC0480-0389) subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. placebo (semaglutide).	Drug: Placebo (NNC080-0389); A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.; Drug: Placebo (semaglutide); A weekly dose of placebo (semaglutide). The study will last for about 41weeks.
Experimental: Semaglutide 2.4 mg + placebo (NNC0480-0389) subjects will receive once weekly subcutaneous (s.c., under the skin) dose of placebo (NNC0480-0389) co-administered with s.c. semaglutide.	Drug: Semaglutide; A weekly dose of semaglutide, same dose in each cohort. The study will last for about 41weeks.; Drug: Placebo (NNC080-0389); A weekly dose of placebo (NNC0480-0389). The study will last for about 41weeks.

Outcome Measures

Primary Outcome Measures

1. Change in HbA1c [From baseline (week 0) to visit 24 (week 34)]

   percentage-point

Secondary Outcome Measures

1. Change in fasting plasma glucose (FPG) [From baseline (week 0) to visit 24 (week 34)]

   measured in mmol/L

2. Change in body weight (kg) [From baseline (week 0) to visit 24 (week 34)]

   measured in kg

3. Change in body weight (%) [From baseline (week 0) to visit 24 (week 34)]

   measured in percent

4. Change in waist circumference [From baseline (week 0) to visit 24 (week 34)]

   measured in cm

5. Change in systolic blood pressure (SBP) [From baseline (week 0) to visit 24 (week 34)]

   measured in mmHg

6. Relative change in total cholesterol [From baseline (week 0) to visit 24 (week 34)]

   ratio

7. Relative change in high-density lipoprotein (HDL) cholesterol [From baseline (week 0) to visit 24 (week 34)]

   ratio

8. Relative change in low-density lipoprotein (LDL) cholesterol [From baseline (week 0) to visit 24 (week 34)]

   ratio

9. Relative change in very-low-density lipoprotein (VLDL) cholesterol [From baseline (week 0) to visit 24 (week 34)]

   ratio

10. Relative change in triglycerides [From baseline (week 0) to visit 24 (week 34)]

    ratio

11. Relative change in free fatty acids [From baseline (week 0) to visit 24 (week 34)]

    ratio

12. Relative change in Apolipoprotein B (ApoB) [From baseline (week 0) to visit 24 (week 34)]

    ratio

13. Relative change in high sensitivity C-Reactive Protein (hsCRP) [From baseline (week 0) to visit 24 (week 34)]

    ratio

14. Number of treatment-emergent adverse events (TEAEs) [From baseline (week 0) to visit 25 (week 39)]

    Count of events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening

• Participants treated with diet and exercise as monotherapy or in combination with stable daily dose(s) greater than or equal to 90 days before screening of any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose

• HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)

• BMI greater than or equal to 25 and below 40 kg/m^2

Exclusion Criteria:

• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed

• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before 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

• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with T2D)

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	Chula Vista	California	United States	91911
3	Novo Nordisk Investigational Site	Escondido	California	United States	92025
4	Novo Nordisk Investigational Site	Fullerton	California	United States	92835
5	Novo Nordisk Investigational Site	La Mesa	California	United States	91942
6	Novo Nordisk Investigational Site	Lancaster	California	United States	93534
7	Novo Nordisk Investigational Site	Lomita	California	United States	90717
8	Novo Nordisk Investigational Site	Los Angeles	California	United States	90057
9	Novo Nordisk Investigational Site	Northridge	California	United States	91325
10	Novo Nordisk Investigational Site	Riverside	California	United States	92503
11	Novo Nordisk Investigational Site	San Diego	California	United States	92103
12	Novo Nordisk Investigational Site	West Hills	California	United States	91304
13	Novo Nordisk Investigational Site	Jacksonville	Florida	United States	32204
14	Novo Nordisk Investigational Site	Miami	Florida	United States	33175
15	Novo Nordisk Investigational Site	Pembroke Pines	Florida	United States	33027
16	Novo Nordisk Investigational Site	Port Orange	Florida	United States	32127
17	Novo Nordisk Investigational Site	Sarasota	Florida	United States	34243
18	Novo Nordisk Investigational Site	Adairsville	Georgia	United States	30103
19	Novo Nordisk Investigational Site	Meridian	Idaho	United States	83646
20	Novo Nordisk Investigational Site	Chicago	Illinois	United States	60607
21	Novo Nordisk Investigational Site	Wauconda	Illinois	United States	60084
22	Novo Nordisk Investigational Site	West Des Moines	Iowa	United States	50265
23	Novo Nordisk Investigational Site	Lexington	Kentucky	United States	40503
24	Novo Nordisk Investigational Site	Lake Charles	Louisiana	United States	70601
25	Novo Nordisk Investigational Site	Boston	Massachusetts	United States	02115-5804
26	Novo Nordisk Investigational Site	Troy	Michigan	United States	48098
27	Novo Nordisk Investigational Site	Butte	Montana	United States	59701
28	Novo Nordisk Investigational Site	Albany	New York	United States	12203
29	Novo Nordisk Investigational Site	New Windsor	New York	United States	12553
30	Novo Nordisk Investigational Site	Chapel Hill	North Carolina	United States	27514
31	Novo Nordisk Investigational Site	Greensboro	North Carolina	United States	27408
32	Novo Nordisk Investigational Site	Greenville	North Carolina	United States	27834
33	Novo Nordisk Investigational Site	Statesville	North Carolina	United States	28625
34	Novo Nordisk Investigational Site	Maumee	Ohio	United States	43537
35	Novo Nordisk Investigational Site	Norman	Oklahoma	United States	73069
36	Novo Nordisk Investigational Site	Tulsa	Oklahoma	United States	74137
37	Novo Nordisk Investigational Site	Spartanburg	South Carolina	United States	29303
38	Novo Nordisk Investigational Site	Dallas	Texas	United States	75230
39	Novo Nordisk Investigational Site	Dallas	Texas	United States	75390-9302
40	Novo Nordisk Investigational Site	Houston	Texas	United States	77058
41	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78209
42	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78230
43	Novo Nordisk Investigational Site	Shavano Park	Texas	United States	78231
44	Novo Nordisk Investigational Site	Kozloduy		Bulgaria	3320
45	Novo Nordisk Investigational Site	Petrich		Bulgaria	2850
46	Novo Nordisk Investigational Site	Sofia		Bulgaria	1431
47	Novo Nordisk Investigational Site	Sofia		Bulgaria	1632
48	Novo Nordisk Investigational Site	Sofia		Bulgaria	1797
49	Novo Nordisk Investigational Site	Stara Zagora		Bulgaria	6000
50	Novo Nordisk Investigational Site	Yambol		Bulgaria	8600
51	Novo Nordisk Investigational Site	Aarhus N		Denmark	8200
52	Novo Nordisk Investigational Site	Hellerup		Denmark	2900
53	Novo Nordisk Investigational Site	Hvidovre		Denmark	2650
54	Novo Nordisk Investigational Site	Athens		Greece	GR-11527
55	Novo Nordisk Investigational Site	Athens		Greece	GR-11528
56	Novo Nordisk Investigational Site	Athens		Greece	GR-15125
57	Novo Nordisk Investigational Site	Athens		Greece	GR-17562
58	Novo Nordisk Investigational Site	Haidari-Athens		Greece	GR-12462
59	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-54643
60	Novo Nordisk Investigational Site	Thessaloniki		Greece	GR-57001
61	Novo Nordisk Investigational Site	Budapest		Hungary	1033
62	Novo Nordisk Investigational Site	Budapest		Hungary	1083
63	Novo Nordisk Investigational Site	Budapest		Hungary	1106
64	Novo Nordisk Investigational Site	Budapest		Hungary	1132
65	Novo Nordisk Investigational Site	Budapest		Hungary	1134
66	Novo Nordisk Investigational Site	Békéscsaba		Hungary	5600
67	Novo Nordisk Investigational Site	Debrecen		Hungary	4032
68	Novo Nordisk Investigational Site	Debrecen		Hungary	4043
69	Novo Nordisk Investigational Site	Gyula		Hungary	5700
70	Novo Nordisk Investigational Site	Kaposvár		Hungary	7400
71	Novo Nordisk Investigational Site	Pécs		Hungary	7623
72	Novo Nordisk Investigational Site	Szombathely		Hungary	H-9700
73	Novo Nordisk Investigational Site	Tatabánya		Hungary	2800
74	Novo Nordisk Investigational Site	Kumamoto		Japan	861-8039
75	Novo Nordisk Investigational Site	Osaka		Japan	553-0003
76	Novo Nordisk Investigational Site	Tokyo		Japan	103-0028
77	Novo Nordisk Investigational Site	Tokyo		Japan	160-0008
78	Novo Nordisk Investigational Site	Tokyo		Japan	169-0072
79	Novo Nordisk Investigational Site	Bialystok		Poland	15-879
80	Novo Nordisk Investigational Site	Klodzko		Poland	57-300
81	Novo Nordisk Investigational Site	Krakow		Poland	31-501
82	Novo Nordisk Investigational Site	Lodz		Poland	90-242
83	Novo Nordisk Investigational Site	Lodz		Poland	91-363
84	Novo Nordisk Investigational Site	Staszow		Poland	28-200
85	Novo Nordisk Investigational Site	Torun		Poland	87-100
86	Novo Nordisk Investigational Site	Warszawa		Poland	01-518
87	Novo Nordisk Investigational Site	Warszawa		Poland	02-507
88	Novo Nordisk Investigational Site	Wroclaw		Poland	50-088
89	Novo Nordisk Investigational Site	Zabrze		Poland	41-800
90	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630005
91	Novo Nordisk Investigational Site	Penza		Russian Federation	440026
92	Novo Nordisk Investigational Site	Saint-Petersburg		Russian Federation	194356
93	Novo Nordisk Investigational Site	Tumen		Russian Federation	625023
94	Novo Nordisk Investigational Site	Belgrade		Serbia	11000
95	Novo Nordisk Investigational Site	Belgrade		Serbia	11000
96	Novo Nordisk Investigational Site	Kragujevac		Serbia	34000

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: NCT05144984
• Other Study ID Numbers: NN9389-4606; U1111-1259-2741; 2020-004863-14
• First Posted: Dec 6, 2021
• Last Update Posted: Apr 1, 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: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 1, 2022