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A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec (COMBINE 1)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IcoSema
Insulin icodec
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key inclusion criteria

  1. Male or female and age above or equal to 18 years at the time of signing informed consent.
  2. Diagnosed with type 2 diabetes mellitus 180 days or more before screening.
  3. HbA1c of 7.0 10.0% (53.0 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.

  4. 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) 20- 80 units/day for 90 days or more before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti diabetic drugs with stable doses for 90 days or more before screening:

    • Metformin
    • Sulfonylureas (a)
    • Meglitinides (glinides) (a)
    • DPP 4 inhibitors (a)
    • Sodium glucose co transporter 2 inhibitors
    • Alpha glucosidase inhibitors
    • Thiazolidinediones
    • Marketed oral combination products only including the products listed above.
  5. Body mass index (BMI) below or equal to 40.0 kg/m^2. (a) Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation.

Key exclusion criteria

  1. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
  2. Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids).
  3. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
  4. Any episodes (as declared by the participant or in the medical records.) of diabetic ketoacidosis within 90 days before screening.
  5. Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
  6. Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
  7. Chronic heart failure classified as being in New York Heart Association Class IV at screening.
  8. Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator.
  9. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 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.

Sites / Locations

  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IcoSema

Insulin icodec

Arm Description

Outcomes

Primary Outcome Measures

Change in glycated haemoglobin (HbA1c)
% point

Secondary Outcome Measures

Change in body weight
Kg
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

Full Information

First Posted
April 24, 2022
Last Updated
October 23, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05352815
Brief Title
A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec
Acronym
COMBINE 1
Official Title
A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Insulin Icodec, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
March 21, 2024 (Anticipated)
Study Completion Date
April 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin icodec taken once a week in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin icodec. Participants will either get IcoSema or insulin icodec. Which treatment participants get is decided by chance. IcoSema and insulin icodec are both new medicines that doctors cannot prescribe. Participants will get IcoSema or insulin icodec, which participants must inject once a week with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will have 21 clinic visits, 31 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. Not applicable for China: Participants will be asked to wear a sensor that measures their blood sugar level all the time during a 5 week period at the end of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IcoSema
Arm Type
Experimental
Arm Title
Insulin icodec
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
IcoSema
Intervention Description
Participants will receive once weekly IcoSema subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Insulin icodec
Intervention Description
Participants will receive once weekly Insulin icodec subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.
Primary Outcome Measure Information:
Title
Change in glycated haemoglobin (HbA1c)
Description
% point
Time Frame
From baseline week 0 (V2) to week 52 (V54)
Secondary Outcome Measure Information:
Title
Change in body weight
Description
Kg
Time Frame
From baseline week 0 (V2) to week 52 (V54)
Title
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)
Description
Number of episodes
Time Frame
From baseline week 0 (V2) to week 57 (V56)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key inclusion criteria Male or female and age above or equal to 18 years at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus 180 days or more before screening. HbA1c of 7.0 10.0% (53.0 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening. 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) 20- 80 units/day for 90 days or more before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti diabetic drugs with stable doses for 90 days or more before screening: Metformin Sulfonylureas (a) Meglitinides (glinides) (a) DPP 4 inhibitors (a) Sodium glucose co transporter 2 inhibitors Alpha glucosidase inhibitors Thiazolidinediones Marketed oral combination products only including the products listed above. Body mass index (BMI) below or equal to 40.0 kg/m^2. (a) Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation. Key exclusion criteria Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids). Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. Any episodes (as declared by the participant or in the medical records.) of diabetic ketoacidosis within 90 days before screening. Presence or history of pancreatitis (acute or chronic) within 180 days before screening. Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening. Chronic heart failure classified as being in New York Heart Association Class IV at screening. Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 2834)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85296
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70461-4231
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115-5804
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Buckley
State/Province
Michigan
ZIP/Postal Code
49620
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03063
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Morristown
State/Province
Tennessee
ZIP/Postal Code
37813
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9302
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Forest
State/Province
Virginia
ZIP/Postal Code
24551
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23501
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Kotara
State/Province
New South Wales
ZIP/Postal Code
2289
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Oaklands Park
State/Province
South Australia
ZIP/Postal Code
5046
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Launceston
State/Province
Tasmania
ZIP/Postal Code
7250
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Kyustendil
ZIP/Postal Code
2500
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Novo Nordisk Investigational Site
City
ChongQing
State/Province
Chongqing
ZIP/Postal Code
404000
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Huizhou
State/Province
Guangdong
ZIP/Postal Code
516001
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Hengshui
State/Province
Hebei
ZIP/Postal Code
053000
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Kaifeng
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Jin'an
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200240
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Osijek
State/Province
Osječko - Baranjska Županija
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Osijek
ZIP/Postal Code
31 000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Pula
ZIP/Postal Code
52100
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Raisio
ZIP/Postal Code
21200
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Tampere
ZIP/Postal Code
33900
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Ähtäri
ZIP/Postal Code
63700
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380052
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kozhikode
State/Province
Kerala
ZIP/Postal Code
673008
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Thriruvananthapuram
State/Province
Kerala
ZIP/Postal Code
695 032
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452010
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolhapur
State/Province
Maharashtra
ZIP/Postal Code
416008
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400008
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Cuttack
State/Province
Orissa
ZIP/Postal Code
753007
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 013
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625020
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500072
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Hyderbad
State/Province
Telengana
ZIP/Postal Code
500 012
Country
India
Facility Name
Novo Nordisk Investigational Site
City
New Delhi
ZIP/Postal Code
110001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bari
State/Province
BA
ZIP/Postal Code
70124
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Chiavari (genova)
ZIP/Postal Code
16034
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Koriyama-shi
State/Province
Fukushima, Japan
ZIP/Postal Code
963-8851
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
State/Province
Hokkaido, Japan
ZIP/Postal Code
060-0062
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Chigasaki-shi, Kanagawa
State/Province
Kanagawa, Japan
ZIP/Postal Code
253-0044
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kumamoto-shi
State/Province
Kumamoto, Japan
ZIP/Postal Code
862-0976
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Miyazaki-shi
State/Province
Miyazaki, Japan
ZIP/Postal Code
880-0034
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Arakawa-ku, Tokyo
ZIP/Postal Code
116-0012
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Chiba-shi, Chiba
ZIP/Postal Code
260-0804
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Fukuoka-shi, Fukuoka
ZIP/Postal Code
819-0006
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Fukuoka-shi, Fukuoka
ZIP/Postal Code
819-0168
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Hokkaido
ZIP/Postal Code
062-0007
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kumamoto
ZIP/Postal Code
861-8039
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Saga-shi, Saga
ZIP/Postal Code
840-0937
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Yokohama-shi, Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Cheonan
State/Province
Chungcheongnam-do
ZIP/Postal Code
31151
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Ansan
State/Province
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
139-827
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Wonju
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Mexico City
ZIP/Postal Code
03300
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Bodø
ZIP/Postal Code
8005
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Drammen
ZIP/Postal Code
3004
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Hamar
ZIP/Postal Code
2318
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Oslo
ZIP/Postal Code
0586
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Trondheim
ZIP/Postal Code
NO-7030
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Lublin
State/Province
Lubelski
ZIP/Postal Code
20-538
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lublin
ZIP/Postal Code
20-044
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Aveiro
ZIP/Postal Code
3814-501
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Vila Nova de Gaia
ZIP/Postal Code
4400-346
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Bayamon
ZIP/Postal Code
00961
Country
Puerto Rico
Facility Name
Novo Nordisk Investigational Site
City
Manati
ZIP/Postal Code
00674
Country
Puerto Rico
Facility Name
Novo Nordisk Investigational Site
City
Bucharest
State/Province
Bucurestii
ZIP/Postal Code
020475
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Baia Mare
State/Province
Maramures
ZIP/Postal Code
430222
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Brasov
ZIP/Postal Code
500101
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Iasi
ZIP/Postal Code
700547
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Satu-Mare
ZIP/Postal Code
440055
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Suceava
ZIP/Postal Code
720237
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Tumen
State/Province
Russia
ZIP/Postal Code
625023
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Irkutsk
ZIP/Postal Code
664049
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Kursk
ZIP/Postal Code
305016
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1820
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1827
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4450
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Brits
State/Province
North West
ZIP/Postal Code
0250
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7572
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Alberton
ZIP/Postal Code
1449
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Changhua City
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Tainan City
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Tainan City
ZIP/Postal Code
710
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Taipei city
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Ankara
State/Province
Altindag
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Adana
ZIP/Postal Code
01150
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Tekirdag
ZIP/Postal Code
59030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec

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