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A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes (FOCUS)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Semaglutide
Placebo (semaglutide)
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, age greater than or equal to 18 years at the time of signing informed consent
  • Diagnosed with type 2 diabetes mellitus.
  • HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).
  • Eye inclusion criteria (both eyes must meet all criteria):
  • Early Treatment Diabetic Retinopathy Study (ETDRS) level of 10-75 (both inclusive) evaluated by fundus photography and confirmed by central reading centre
  • No ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema six months prior to the day of screening.
  • No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within three months after randomisation.
  • Best-corrected visual acuity greater than or equal to 30 letters using the ETDRS visual acuity protocol
  • No previous treatment with pan-retinal laser photocoagulation
  • No substantial non-diabetic ocular condition that, in the opinion of the ophthalmologist, would impact diabetic retinopathy or diabetic macular oedema progression during the trial
  • No substantial media opacities that would preclude successful imaging

Exclusion Criteria:

  • Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
  • Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
  • Subjects presently classified as being in New York Heart Association (NYHA) Class IV
  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR less than 30 ml/min/1.73 m^2
  • Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
  • Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods
  • Concurrent treatment with any GLP-1 receptor agonist or DPP-4 inhibitor from randomisation.
  • Receipt of any investigational medicinal product within 30 days before screening
  • Previous participation in this trial. Participation is defined as randomisation
  • Known or suspected hypersensitivity to trial products or related products
  • Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

Sites / Locations

  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Semaglutide

Placebo

Arm Description

Participants will receive semaglutide once weekly as subcutaneous (s.c., under the skin) injection added to standard of care.

Participants will receive placebo (semaglutide) once weekly as subcutaneous subcutaneous (s.c., under the skin) injection added to standard of care.

Outcomes

Primary Outcome Measures

Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression.
Percentage of subjects (yes/no).

Secondary Outcome Measures

Time from randomisation to first at least 3 steps ETDRS subject level progression or central involved diabetic macular oedema (ciDME) in either eye.
Measured in months.
Change in visual acuity in the worse seeing eye.
Measured in number of letters using the ETDRS protocol.
Change in visual acuity in the better seeing eye.
Measured in number of letters using the ETDRS protocol.
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with focal/grid laser photocoagulation.
Percentage of subjects (yes/no).
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with pan-retinal laser photocoagulation.
Percentage of subjects (yes/no).
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with anti-vascular endothelial growth factor (VEGF).
Percentage of subjects (yes/no).
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with steroid.
Percentage of subjects (yes/no).
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with vitrectomy.
Percentage of subjects (yes/no).
Presence of at least 3 steps ETDRS subject level improvement.
Percentage of subjects (yes/no).
Presence of at least 2 steps ETDRS subject level progression.
Percentage of subjects (yes/no).
Presence of at least 2 steps ETDRS subject level improvement.
Percentage of subjects (yes/no).
Presence of persistent visual acuity up to 38 ETDRS letters in either eye.
Percentage of subjects (yes/no).
Presence of persistent at least 2 lines (10 letters) ETDRS worsening in visual acuity in either eye from baseline.
Percentage of subjects (yes/no).
Presence of persistent at least 3 lines (15 letters) ETDRS worsening in visual acuity in either eye from baseline.
Percentage of subjects (yes/no).
Presence of persistent at least 2 lines (10 letters) ETDRS improvement in visual acuity in either eye from baseline.
Percentage of subjects (yes/no).
Persistent at least 3 lines (15 letters) ETDRS improvement in visual acuity in either eye from baseline.
Percentage of subjects (yes/no).
Presence of ciDME in either eye.
Percentage of subjects (yes/no).
Change in glycosylated haemoglobin (HbA1c).
Measured in %-points.
Change in body weight.
Measured in kg.
Change in systolic and diastolic blood pressure.
Measured in mmHg.
Change in Lipids: Total-cholesterol, High density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol and triglycerides.
Measured in mmol/L

Full Information

First Posted
January 18, 2019
Last Updated
September 19, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT03811561
Brief Title
A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes
Acronym
FOCUS
Official Title
Long-term Effects of Semaglutide on Diabetic Retinopathy in Subjects With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
December 25, 2026 (Anticipated)
Study Completion Date
November 7, 2027 (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
Yes

5. Study Description

Brief Summary
This study will look at the long-term effects of semaglutide (active medicine) on diabetic eye disease when compared to placebo (dummy medicine). The study will be performed in people with type 2 diabetes. Participants will either get semaglutide or placebo in addition to their diabetes medicines - which treatment the participant gets is decided by chance. Participants will inject the study medicine using a pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. The study will last for 5 years.

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide
Arm Type
Experimental
Arm Description
Participants will receive semaglutide once weekly as subcutaneous (s.c., under the skin) injection added to standard of care.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo (semaglutide) once weekly as subcutaneous subcutaneous (s.c., under the skin) injection added to standard of care.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Participants will get one dose of semaglutide once weekly in addition to their diabetes medicines - which treatment they get is decided by chance. Participants will inject the study medicine using a pre-filled PDS290 pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. Participants will start with once-weekly doses of 0.25 mg for 4 weeks, then the dose will be gradually increased to 0.5 mg once weekly for 4 weeks, and finally to 1.0 mg once weekly (maximum dose) up to 260 weeks (5 years).
Intervention Type
Drug
Intervention Name(s)
Placebo (semaglutide)
Intervention Description
Participants will get one dose of placebo (semaglutide) once weekly in addition to their diabetes medicines - which treatment they get is decided by chance. Participants will inject the study medicine using a pre-filled PDS290 pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. Participants will start with once-weekly doses of 0.25 mg for 4 weeks, then the dose will be gradually increased to 0.5 mg once weekly for 4 weeks, and finally to 1.0 mg once weekly (maximum dose) up to 260 weeks (5 years).
Primary Outcome Measure Information:
Title
Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression.
Description
Percentage of subjects (yes/no).
Time Frame
Year 5
Secondary Outcome Measure Information:
Title
Time from randomisation to first at least 3 steps ETDRS subject level progression or central involved diabetic macular oedema (ciDME) in either eye.
Description
Measured in months.
Time Frame
Up to 5 years
Title
Change in visual acuity in the worse seeing eye.
Description
Measured in number of letters using the ETDRS protocol.
Time Frame
Week 0, Year 5
Title
Change in visual acuity in the better seeing eye.
Description
Measured in number of letters using the ETDRS protocol.
Time Frame
Week 0, Year 5
Title
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with focal/grid laser photocoagulation.
Description
Percentage of subjects (yes/no).
Time Frame
Week 0-Year 5
Title
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with pan-retinal laser photocoagulation.
Description
Percentage of subjects (yes/no).
Time Frame
Week 0-Year 5
Title
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with anti-vascular endothelial growth factor (VEGF).
Description
Percentage of subjects (yes/no).
Time Frame
Week 0-Year 5
Title
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with steroid.
Description
Percentage of subjects (yes/no).
Time Frame
Week 0-Year 5
Title
Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with vitrectomy.
Description
Percentage of subjects (yes/no).
Time Frame
Week 0-Year 5
Title
Presence of at least 3 steps ETDRS subject level improvement.
Description
Percentage of subjects (yes/no).
Time Frame
Year 5
Title
Presence of at least 2 steps ETDRS subject level progression.
Description
Percentage of subjects (yes/no).
Time Frame
Year 5
Title
Presence of at least 2 steps ETDRS subject level improvement.
Description
Percentage of subjects (yes/no).
Time Frame
Year 5
Title
Presence of persistent visual acuity up to 38 ETDRS letters in either eye.
Description
Percentage of subjects (yes/no).
Time Frame
Year 5
Title
Presence of persistent at least 2 lines (10 letters) ETDRS worsening in visual acuity in either eye from baseline.
Description
Percentage of subjects (yes/no).
Time Frame
Year 5
Title
Presence of persistent at least 3 lines (15 letters) ETDRS worsening in visual acuity in either eye from baseline.
Description
Percentage of subjects (yes/no).
Time Frame
Year 5
Title
Presence of persistent at least 2 lines (10 letters) ETDRS improvement in visual acuity in either eye from baseline.
Description
Percentage of subjects (yes/no).
Time Frame
Year 5
Title
Persistent at least 3 lines (15 letters) ETDRS improvement in visual acuity in either eye from baseline.
Description
Percentage of subjects (yes/no).
Time Frame
Year 5
Title
Presence of ciDME in either eye.
Description
Percentage of subjects (yes/no).
Time Frame
Year 5
Title
Change in glycosylated haemoglobin (HbA1c).
Description
Measured in %-points.
Time Frame
Week 0, Year 5
Title
Change in body weight.
Description
Measured in kg.
Time Frame
Week 0, Year 5
Title
Change in systolic and diastolic blood pressure.
Description
Measured in mmHg.
Time Frame
Week 0, Year 5
Title
Change in Lipids: Total-cholesterol, High density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol and triglycerides.
Description
Measured in mmol/L
Time Frame
Week 0, Year 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, age greater than or equal to 18 years at the time of signing informed consent Diagnosed with type 2 diabetes mellitus. HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive). Eye inclusion criteria (both eyes must meet all criteria): Early Treatment Diabetic Retinopathy Study (ETDRS) level of 10-75 (both inclusive) evaluated by fundus photography and confirmed by central reading centre No ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema six months prior to the day of screening. No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within three months after randomisation. Best-corrected visual acuity greater than or equal to 30 letters using the ETDRS visual acuity protocol No previous treatment with pan-retinal laser photocoagulation No substantial non-diabetic ocular condition that, in the opinion of the ophthalmologist, would impact diabetic retinopathy or diabetic macular oedema progression during the trial No substantial media opacities that would preclude successful imaging Exclusion Criteria: Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening Planned coronary, carotid or peripheral artery revascularisation known on the day of screening Subjects presently classified as being in New York Heart Association (NYHA) Class IV Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR less than 30 ml/min/1.73 m^2 Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods Concurrent treatment with any GLP-1 receptor agonist or DPP-4 inhibitor from randomisation. Receipt of any investigational medicinal product within 30 days before screening Previous participation in this trial. Participation is defined as randomisation Known or suspected hypersensitivity to trial products or related products Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Reporting Anchor and Disclosure (1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
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 Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730-3063
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
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
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
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
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
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
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
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
87131
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28226
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620-7352
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
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
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
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Shavano Park
State/Province
Texas
ZIP/Postal Code
78231
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
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Pleven
ZIP/Postal Code
5806
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Facility Name
Novo Nordisk Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
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
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M9R 4E1
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
Saint-Laurent
State/Province
Quebec
ZIP/Postal Code
H4T 1Z9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Friedrichsthal
ZIP/Postal Code
66299
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
21109
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Münster
ZIP/Postal Code
48153
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Rehlingen-Siersburg
ZIP/Postal Code
66780
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Saint Ingbert-Oberwürzbach
ZIP/Postal Code
66386
Country
Germany
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-11527
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Athens
ZIP/Postal Code
GR-17562
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Haidari-Athens
ZIP/Postal Code
GR-12462
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
Guntur
State/Province
Andhra Pradesh
ZIP/Postal Code
522001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 099
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560010
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682041
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Thiruvananthapuram
State/Province
Kerala
ZIP/Postal Code
695031
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
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440003
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ansari Nagar, New Delhi 110029
State/Province
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Delhi
State/Province
New Delhi
ZIP/Postal Code
110076
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600086
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625 020
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700020
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700054
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
ZIP/Postal Code
600034
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Haifa
ZIP/Postal Code
31096
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
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Jelgava
ZIP/Postal Code
LV-3001
Country
Latvia
Facility Name
Novo Nordisk Investigational Site
City
Ogre
ZIP/Postal Code
LV-5001
Country
Latvia
Facility Name
Novo Nordisk Investigational Site
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Novo Nordisk Investigational Site
City
Riga
ZIP/Postal Code
LV-1011
Country
Latvia
Facility Name
Novo Nordisk Investigational Site
City
Riga
ZIP/Postal Code
LV-1024
Country
Latvia
Facility Name
Novo Nordisk Investigational Site
City
Distrito Federal
State/Province
México, D.F.
ZIP/Postal Code
14080
Country
Mexico
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
Bialystok
State/Province
Podlaskie Voivodeship
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-048
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gdansk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Gdansk
ZIP/Postal Code
80-858
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lodz
ZIP/Postal Code
94-074 LODZ
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Plonsk
ZIP/Postal Code
09-100
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Poznan
ZIP/Postal Code
60-821
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Poznan
ZIP/Postal Code
61-251
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Zabrze
ZIP/Postal Code
41-800
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
Coimbra
ZIP/Postal Code
3000-459
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1250-230
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Setubal
ZIP/Postal Code
2910-446
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Cluj Napoca
State/Province
Cluj
ZIP/Postal Code
400006
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300456
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300736
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Bucharest
ZIP/Postal Code
010825
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Bucharest
ZIP/Postal Code
011025
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Bucharest
ZIP/Postal Code
020358
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Barnaul
ZIP/Postal Code
656043
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Kazan
ZIP/Postal Code
420061
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
Saint-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saratov
ZIP/Postal Code
410031
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saratov
ZIP/Postal Code
410039
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Bratislava
ZIP/Postal Code
833 05
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Zilina
ZIP/Postal Code
01001
Country
Slovakia
Facility Name
Novo Nordisk Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Norfolk
ZIP/Postal Code
NR4 7UQ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
North Yorkshire
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Nuneaton
ZIP/Postal Code
CV10 7DJ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Somerset
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom

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 Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes

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