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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 Semaglutide (COMBINE 2) (COMBINE 2)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IcoSema
Semaglutide 1 mg
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

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.
  • Insulin naïve. The following exceptions are permitted: short term insulin treatment for a maximum of 14 days before screening and/or prior insulin treatment for gestational diabetes.
  • Treated with stable doses of daily or weekly GLP-1 receptor agonist (excluding once weekly semaglutide with doses higher than 1.0 mg) according to local label for the treatment of diabetes for 90 days or more before screening. 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 (Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation) - Meglitinides (glinides)(Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation) - DPP 4 inhibitors (Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation) - 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.

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.
  • 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

Experimental

Arm Label

IcoSema

Semaglutide

Arm Description

Participants will get once weekly dose

Participants will get once weekly dose

Outcomes

Primary Outcome Measures

Change in glycated haemoglobin (HbA1c)
Percentage-point

Secondary Outcome Measures

Change in fasting plasma glucose (FPG)
Measured in mmol/L
Change in body weight
Measured in 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
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Number of episodes
Number of severe hypoglycaemic episodes (level 3)
Number of episodes

Full Information

First Posted
February 10, 2022
Last Updated
October 11, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05259033
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 Semaglutide (COMBINE 2)
Acronym
COMBINE 2
Official Title
A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Once Weekly Semaglutide, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With a GLP 1 Receptor Agonist. COMBINE 2
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 11, 2022 (Actual)
Primary Completion Date
December 13, 2023 (Anticipated)
Study Completion Date
January 17, 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 semaglutide 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 semaglutide. Participants will either get IcoSema or semaglutide. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe semaglutide in many countries. Participants will get IcoSema or semaglutide, which they 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 18 clinic visits, 34 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.

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
680 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IcoSema
Arm Type
Experimental
Arm Description
Participants will get once weekly dose
Arm Title
Semaglutide
Arm Type
Experimental
Arm Description
Participants will get once weekly dose
Intervention Type
Drug
Intervention Name(s)
IcoSema
Intervention Description
IcoSema once weekly subcutaneously (s.c., under the skin) using a needle and a pen. For about 1 year and 1 month.
Intervention Type
Drug
Intervention Name(s)
Semaglutide 1 mg
Intervention Description
Semaglutide once weekly subcutaneously (s.c., under the skin). Dose titrated to 1mg over 8 weeks (0.25 mg for 4 weeks, 0.5 mg for 4 weeks). For about 1 year and 1 month.
Primary Outcome Measure Information:
Title
Change in glycated haemoglobin (HbA1c)
Description
Percentage-point
Time Frame
From baseline week 0 (V2) to week 52 (V54)
Secondary Outcome Measure Information:
Title
Change in fasting plasma glucose (FPG)
Description
Measured in mmol/L
Time Frame
From baseline week 0 (V2) to week 52 (V54)
Title
Change in body weight
Description
Measured in 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)
Title
Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
Description
Number of episodes
Time Frame
From baseline week 0 (V2) to week 57 (V56)
Title
Number of 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
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. Insulin naïve. The following exceptions are permitted: short term insulin treatment for a maximum of 14 days before screening and/or prior insulin treatment for gestational diabetes. Treated with stable doses of daily or weekly GLP-1 receptor agonist (excluding once weekly semaglutide with doses higher than 1.0 mg) according to local label for the treatment of diabetes for 90 days or more before screening. 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 (Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation) - Meglitinides (glinides)(Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation) - DPP 4 inhibitors (Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation) - 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. 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. 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. 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
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
Sun City West
State/Province
Arizona
ZIP/Postal Code
85375
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
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
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mount Dora
State/Province
Florida
ZIP/Postal Code
32757
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
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
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686-6011
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
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
Buckley
State/Province
Michigan
ZIP/Postal Code
49620
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
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
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
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
Canton
State/Province
Ohio
ZIP/Postal Code
44718
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
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
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
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
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
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
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
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
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
78233
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
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
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60150-162
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Aparecida de Goiania
State/Province
Goias
ZIP/Postal Code
74935-530
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80045-170
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
São José dos Campos
State/Province
Sao Paulo
ZIP/Postal Code
12243-280
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05003-090
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Concord
State/Province
Ontario
ZIP/Postal Code
L4K 4M2
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 2M1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G4T3
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4T 1Z9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Saint-Laurent
State/Province
Quebec
ZIP/Postal Code
H4T 1Z9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Quebec
ZIP/Postal Code
G1G 3Y8
Country
Canada
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
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
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
200040
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
300070
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Bois-Guillaume
ZIP/Postal Code
76230
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Le Coudray
ZIP/Postal Code
28630
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Le Creusot
ZIP/Postal Code
71200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Saint Herblain
ZIP/Postal Code
44800
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Toulouse
ZIP/Postal Code
31054
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Venissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
115 25
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-10676
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-115 27
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-11526
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Larissa
ZIP/Postal Code
GR-41110
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-54635
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-54642
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-57001
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR-57010
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
H-4043
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1132
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Haifa
ZIP/Postal Code
35152
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Herzlia
ZIP/Postal Code
4630945
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
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
Chuo-ku, Tokyo
ZIP/Postal Code
103-0002
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
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Ibaraki
ZIP/Postal Code
311-0113
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Osaka
ZIP/Postal Code
569-1045
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Saitama
ZIP/Postal Code
336-0967
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Saitama
ZIP/Postal Code
340-0034
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Sendai-shi, Miyagi
ZIP/Postal Code
983-0039
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Irkutsk
ZIP/Postal Code
664049
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
117292
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Omsk
ZIP/Postal Code
644029
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Penza
ZIP/Postal Code
440052
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Yoshkar-Ola
ZIP/Postal Code
424004
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Kosice
ZIP/Postal Code
04011
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Kosice
ZIP/Postal Code
04190
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Levice
ZIP/Postal Code
93401
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Moldava nad Bodvou
ZIP/Postal Code
045 01
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Turcianske Teplice
ZIP/Postal Code
039 01
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Göteborg
ZIP/Postal Code
413 46
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Stockholm
ZIP/Postal Code
113 65
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Örebro
ZIP/Postal Code
703 62
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Luzern 16
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Olten
ZIP/Postal Code
4600
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Zollikerberg
ZIP/Postal Code
8125
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Taichung City
ZIP/Postal Code
402
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
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Taoyuan city
ZIP/Postal Code
333
Country
Taiwan

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 Semaglutide (COMBINE 2)

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