FOCUS: A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03811561
Collaborator
(none)
1,500
186
2
100
8.1
0.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
1500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose:
Treatment
Official Title:
Long-term Effects of Semaglutide on Diabetic Retinopathy in Subjects With Type 2 Diabetes
Actual Study Start Date
:
May 8, 2019
Anticipated Primary Completion Date
:
Dec 25, 2026
Anticipated Study Completion Date
:
Sep 7, 2027
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Semaglutide Participants will receive semaglutide once weekly as subcutaneous (s.c., under the skin) injection added to standard of care. |
Drug: Semaglutide
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).
|
| Placebo Comparator: Placebo Participants will receive placebo (semaglutide) once weekly as subcutaneous subcutaneous (s.c., under the skin) injection added to standard of care. |
Drug: Placebo (semaglutide)
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).
|
Outcome Measures
Primary Outcome Measures
- Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression. [Year 5]
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. [Up to 5 years]
Measured in months.
- Change in visual acuity in the worse seeing eye. [Week 0, Year 5]
Measured in number of letters using the ETDRS protocol.
- Change in visual acuity in the better seeing eye. [Week 0, Year 5]
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. [Week 0-Year 5]
Percentage of subjects (yes/no).
- Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with pan-retinal laser photocoagulation. [Week 0-Year 5]
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). [Week 0-Year 5]
Percentage of subjects (yes/no).
- Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with steroid. [Week 0-Year 5]
Percentage of subjects (yes/no).
- Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with vitrectomy. [Week 0-Year 5]
Percentage of subjects (yes/no).
- Presence of at least 3 steps ETDRS subject level improvement. [Year 5]
Percentage of subjects (yes/no).
- Presence of at least 2 steps ETDRS subject level progression. [Year 5]
Percentage of subjects (yes/no).
- Presence of at least 2 steps ETDRS subject level improvement. [Year 5]
Percentage of subjects (yes/no).
- Presence of persistent visual acuity up to 38 ETDRS letters in either eye. [Year 5]
Percentage of subjects (yes/no).
- Presence of persistent at least 2 lines (10 letters) ETDRS worsening in visual acuity in either eye from baseline. [Year 5]
Percentage of subjects (yes/no).
- Presence of persistent at least 3 lines (15 letters) ETDRS worsening in visual acuity in either eye from baseline. [Year 5]
Percentage of subjects (yes/no).
- Presence of persistent at least 2 lines (10 letters) ETDRS improvement in visual acuity in either eye from baseline. [Year 5]
Percentage of subjects (yes/no).
- Persistent at least 3 lines (15 letters) ETDRS improvement in visual acuity in either eye from baseline. [Year 5]
Percentage of subjects (yes/no).
- Presence of ciDME in either eye. [Year 5]
Percentage of subjects (yes/no).
- Change in glycosylated haemoglobin (HbA1c). [Week 0, Year 5]
Measured in %-points.
- Change in body weight. [Week 0, Year 5]
Measured in kg.
- Change in systolic and diastolic blood pressure. [Week 0, Year 5]
Measured in mmHg.
- Change in Lipids: Total-cholesterol, High density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol and triglycerides. [Week 0, Year 5]
Measured in mmol/L
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female, 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Phoenix | Arizona | United States | 85050 |
| 2 | Novo Nordisk Investigational Site | Tucson | Arizona | United States | 85723 |
| 3 | Novo Nordisk Investigational Site | Tucson | Arizona | United States | 85741 |
| 4 | Novo Nordisk Investigational Site | Costa Mesa | California | United States | 92627 |
| 5 | Novo Nordisk Investigational Site | Huntington Beach | California | United States | 92648 |
| 6 | Novo Nordisk Investigational Site | La Jolla | California | United States | 92037 |
| 7 | Novo Nordisk Investigational Site | Lomita | California | United States | 90717 |
| 8 | Novo Nordisk Investigational Site | Los Angeles | California | United States | 90010 |
| 9 | Novo Nordisk Investigational Site | Los Angeles | California | United States | 90017 |
| 10 | Novo Nordisk Investigational Site | Moreno Valley | California | United States | 92555 |
| 11 | Novo Nordisk Investigational Site | Rancho Cucamonga | California | United States | 91730-3063 |
| 12 | Novo Nordisk Investigational Site | Sacramento | California | United States | 95821 |
| 13 | Novo Nordisk Investigational Site | Santa Monica | California | United States | 90404 |
| 14 | Novo Nordisk Investigational Site | Ventura | California | United States | 93003 |
| 15 | Novo Nordisk Investigational Site | Walnut Creek | California | United States | 94598 |
| 16 | Novo Nordisk Investigational Site | Aurora | Colorado | United States | 80045 |
| 17 | Novo Nordisk Investigational Site | Waterbury | Connecticut | United States | 06708 |
| 18 | Novo Nordisk Investigational Site | Clearwater | Florida | United States | 33756 |
| 19 | Novo Nordisk Investigational Site | Jacksonville | Florida | United States | 32216 |
| 20 | Novo Nordisk Investigational Site | Miami | Florida | United States | 33175 |
| 21 | Novo Nordisk Investigational Site | Ocala | Florida | United States | 34471 |
| 22 | Novo Nordisk Investigational Site | Atlanta | Georgia | United States | 30318 |
| 23 | Novo Nordisk Investigational Site | Roswell | Georgia | United States | 30076 |
| 24 | Novo Nordisk Investigational Site | Chicago | Illinois | United States | 60607 |
| 25 | Novo Nordisk Investigational Site | Chicago | Illinois | United States | 60637 |
| 26 | Novo Nordisk Investigational Site | Avon | Indiana | United States | 46123 |
| 27 | Novo Nordisk Investigational Site | Greenfield | Indiana | United States | 46140 |
| 28 | Novo Nordisk Investigational Site | West Des Moines | Iowa | United States | 50265 |
| 29 | Novo Nordisk Investigational Site | Lexington | Kentucky | United States | 40502 |
| 30 | Novo Nordisk Investigational Site | Lexington | Kentucky | United States | 40503 |
| 31 | Novo Nordisk Investigational Site | Lexington | Kentucky | United States | 40503 |
| 32 | Novo Nordisk Investigational Site | Louisville | Kentucky | United States | 40213 |
| 33 | Novo Nordisk Investigational Site | Paducah | Kentucky | United States | 42001 |
| 34 | Novo Nordisk Investigational Site | Hyattsville | Maryland | United States | 20782 |
| 35 | Novo Nordisk Investigational Site | Boston | Massachusetts | United States | 02115-5804 |
| 36 | Novo Nordisk Investigational Site | Boston | Massachusetts | United States | 02118 |
| 37 | Novo Nordisk Investigational Site | Boston | Massachusetts | United States | 02215 |
| 38 | Novo Nordisk Investigational Site | Ann Arbor | Michigan | United States | 48109 |
| 39 | Novo Nordisk Investigational Site | Richfield | Minnesota | United States | 55432 |
| 40 | Novo Nordisk Investigational Site | Chesterfield | Missouri | United States | 63017 |
| 41 | Novo Nordisk Investigational Site | Las Vegas | Nevada | United States | 89148 |
| 42 | Novo Nordisk Investigational Site | Nashua | New Hampshire | United States | 03063 |
| 43 | Novo Nordisk Investigational Site | Albuquerque | New Mexico | United States | 87108 |
| 44 | Novo Nordisk Investigational Site | Albuquerque | New Mexico | United States | 87131 |
| 45 | Novo Nordisk Investigational Site | New York | New York | United States | 10016 |
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| 49 | Novo Nordisk Investigational Site | Mentor | Ohio | United States | 44060 |
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| 51 | Novo Nordisk Investigational Site | Oklahoma City | Oklahoma | United States | 73104 |
| 52 | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | United States | 19114 |
| 53 | Novo Nordisk Investigational Site | Bristol | Tennessee | United States | 37620-7352 |
| 54 | Novo Nordisk Investigational Site | Chattanooga | Tennessee | United States | 37411 |
| 55 | Novo Nordisk Investigational Site | Kingsport | Tennessee | United States | 37660 |
| 56 | Novo Nordisk Investigational Site | Nashville | Tennessee | United States | 37212 |
| 57 | Novo Nordisk Investigational Site | Austin | Texas | United States | 78705 |
| 58 | Novo Nordisk Investigational Site | Austin | Texas | United States | 78731 |
| 59 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75230 |
| 60 | Novo Nordisk Investigational Site | Dallas | Texas | United States | 75390-9302 |
| 61 | Novo Nordisk Investigational Site | San Antonio | Texas | United States | 78229 |
| 62 | Novo Nordisk Investigational Site | San Antonio | Texas | United States | 78230 |
| 63 | Novo Nordisk Investigational Site | Shavano Park | Texas | United States | 78231 |
| 64 | Novo Nordisk Investigational Site | Sugar Land | Texas | United States | 77478 |
| 65 | Novo Nordisk Investigational Site | Murray | Utah | United States | 84107 |
| 66 | Novo Nordisk Investigational Site | Spokane | Washington | United States | 99202 |
| 67 | Novo Nordisk Investigational Site | São Paulo | Sao Paulo | Brazil | 01228-000 |
| 68 | Novo Nordisk Investigational Site | Pleven | Bulgaria | 5800 | |
| 69 | Novo Nordisk Investigational Site | Pleven | Bulgaria | 5806 | |
| 70 | Novo Nordisk Investigational Site | Plovdiv | Bulgaria | 4002 | |
| 71 | Novo Nordisk Investigational Site | Plovdiv | Bulgaria | 4003 | |
| 72 | Novo Nordisk Investigational Site | Sofia | Bulgaria | 1233 | |
| 73 | Novo Nordisk Investigational Site | Sofia | Bulgaria | 1431 | |
| 74 | Novo Nordisk Investigational Site | Sofia | Bulgaria | 1606 | |
| 75 | Novo Nordisk Investigational Site | Sofia | Bulgaria | 1618 | |
| 76 | Novo Nordisk Investigational Site | Edmonton | Alberta | Canada | T6G 2E1 |
| 77 | Novo Nordisk Investigational Site | Concord | Ontario | Canada | L4K 4M2 |
| 78 | Novo Nordisk Investigational Site | Etobicoke | Ontario | Canada | M9R 4E1 |
| 79 | Novo Nordisk Investigational Site | Oakville | Ontario | Canada | L6M 1M1 |
| 80 | Novo Nordisk Investigational Site | Ottawa | Ontario | Canada | K1H7W9 |
| 81 | Novo Nordisk Investigational Site | Toronto | Ontario | Canada | M4G 3E8 |
| 82 | Novo Nordisk Investigational Site | Montreal | Quebec | Canada | H4A 2C6 |
| 83 | Novo Nordisk Investigational Site | Montreal | Quebec | Canada | H4T 1Z9 |
| 84 | Novo Nordisk Investigational Site | Brno | Czechia | 62500 | |
| 85 | Novo Nordisk Investigational Site | Hradec Kralove | Czechia | 500 05 | |
| 86 | Novo Nordisk Investigational Site | Praha 10 | Czechia | 100 00 | |
| 87 | Novo Nordisk Investigational Site | Praha 4 | Czechia | 140 00 | |
| 88 | Novo Nordisk Investigational Site | Praha | Czechia | 100 34 | |
| 89 | Novo Nordisk Investigational Site | Friedrichsthal | Germany | 66299 | |
| 90 | Novo Nordisk Investigational Site | Hamburg | Germany | 21073 | |
| 91 | Novo Nordisk Investigational Site | Hamburg | Germany | 22607 | |
| 92 | Novo Nordisk Investigational Site | Münster | Germany | 48145 | |
| 93 | Novo Nordisk Investigational Site | Münster | Germany | 48153 | |
| 94 | Novo Nordisk Investigational Site | Rehlingen-Siersburg | Germany | 66780 | |
| 95 | Novo Nordisk Investigational Site | Saint Ingbert-Oberwürzbach | Germany | 66386 | |
| 96 | Novo Nordisk Investigational Site | Athens | Greece | 115 25 | |
| 97 | Novo Nordisk Investigational Site | Athens | Greece | GR-11527 | |
| 98 | Novo Nordisk Investigational Site | Haidari-Athens | Greece | GR-12462 | |
| 99 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-54642 | |
| 100 | Novo Nordisk Investigational Site | Thessaloniki | Greece | GR-57001 | |
| 101 | Novo Nordisk Investigational Site | Guntur | Andhra Pradesh | India | 522001 |
| 102 | Novo Nordisk Investigational Site | Bangalore | Karnataka | India | 560 099 |
| 103 | Novo Nordisk Investigational Site | Kochi | Kerala | India | 682041 |
| 104 | Novo Nordisk Investigational Site | Thiruvananthapuram | Kerala | India | 695031 |
| 105 | Novo Nordisk Investigational Site | Mumbai | Maharashtra | India | 400008 |
| 106 | Novo Nordisk Investigational Site | Nagpur | Maharashtra | India | 440003 |
| 107 | Novo Nordisk Investigational Site | Pune | Maharashtra | India | 411004 |
| 108 | Novo Nordisk Investigational Site | Delhi | New Delhi | India | 110076 |
| 109 | Novo Nordisk Investigational Site | New Dehli | New Delhi | India | 110029 |
| 110 | Novo Nordisk Investigational Site | Ludhiana | Punjab | India | 141001 |
| 111 | Novo Nordisk Investigational Site | Ludhiana | Punjab | India | 141008 |
| 112 | Novo Nordisk Investigational Site | Chennai | Tamil Nadu | India | 600086 |
| 113 | Novo Nordisk Investigational Site | Madurai | Tamil Nadu | India | 625 020 |
| 114 | Novo Nordisk Investigational Site | Kolkata | West Bengal | India | 700054 |
| 115 | Novo Nordisk Investigational Site | Bangalore | India | 560010 | |
| 116 | Novo Nordisk Investigational Site | Hyderabad | India | 600034 | |
| 117 | Novo Nordisk Investigational Site | Haifa | Israel | 31096 | |
| 118 | Novo Nordisk Investigational Site | Jerusalem | Israel | 91120 | |
| 119 | Novo Nordisk Investigational Site | Kfar Saba | Israel | 44281 | |
| 120 | Novo Nordisk Investigational Site | Petah-Tikva | Israel | 49100 | |
| 121 | Novo Nordisk Investigational Site | Tel Hashomer | Israel | 52621 | |
| 122 | Novo Nordisk Investigational Site | Tel-Aviv | Israel | 64239 | |
| 123 | Novo Nordisk Investigational Site | Jelgava | Latvia | LV-3001 | |
| 124 | Novo Nordisk Investigational Site | Ogre | Latvia | LV-5001 | |
| 125 | Novo Nordisk Investigational Site | Riga | Latvia | LV-1002 | |
| 126 | Novo Nordisk Investigational Site | Riga | Latvia | LV-1011 | |
| 127 | Novo Nordisk Investigational Site | Riga | Latvia | LV-1024 | |
| 128 | Novo Nordisk Investigational Site | Distrito Federal | México, D.F. | Mexico | 14080 |
| 129 | Novo Nordisk Investigational Site | Monterrey | Nuevo León | Mexico | 64460 |
| 130 | Novo Nordisk Investigational Site | Bialystok | Poland | 15-276 | |
| 131 | Novo Nordisk Investigational Site | Chorzow | Poland | 41-500 | |
| 132 | Novo Nordisk Investigational Site | Gdansk | Poland | 80-382 | |
| 133 | Novo Nordisk Investigational Site | Gdansk | Poland | 80-858 | |
| 134 | Novo Nordisk Investigational Site | Katowice | Poland | 40-156 | |
| 135 | Novo Nordisk Investigational Site | Krakow | Poland | 31-501 | |
| 136 | Novo Nordisk Investigational Site | Lodz | Poland | 90-242 | |
| 137 | Novo Nordisk Investigational Site | Lodz | Poland | 90-302 | |
| 138 | Novo Nordisk Investigational Site | Lodz | Poland | 94-074 LODZ | |
| 139 | Novo Nordisk Investigational Site | Plonsk | Poland | 09-100 | |
| 140 | Novo Nordisk Investigational Site | Poznan | Poland | 60-821 | |
| 141 | Novo Nordisk Investigational Site | Poznan | Poland | 61-251 | |
| 142 | Novo Nordisk Investigational Site | Zabrze | Poland | 41-800 | |
| 143 | Novo Nordisk Investigational Site | Almada | Portugal | 2805-267 | |
| 144 | Novo Nordisk Investigational Site | Aveiro | Portugal | 3814-501 | |
| 145 | Novo Nordisk Investigational Site | Coimbra | Portugal | 3000-561 | |
| 146 | Novo Nordisk Investigational Site | Guimarães | Portugal | 4835-044 | |
| 147 | Novo Nordisk Investigational Site | Lisboa | Portugal | 1250-230 | |
| 148 | Novo Nordisk Investigational Site | Matosinhos | Portugal | 4464-513 | |
| 149 | Novo Nordisk Investigational Site | Porto | Portugal | 4200-319 | |
| 150 | Novo Nordisk Investigational Site | Setubal | Portugal | 2910-446 | |
| 151 | Novo Nordisk Investigational Site | Cluj Napoca | Cluj | Romania | 400006 |
| 152 | Novo Nordisk Investigational Site | Timisoara | Timis | Romania | 300736 |
| 153 | Novo Nordisk Investigational Site | Bucharest | Romania | 010825 | |
| 154 | Novo Nordisk Investigational Site | Bucharest | Romania | 011025 | |
| 155 | Novo Nordisk Investigational Site | Bucharest | Romania | 020359 | |
| 156 | Novo Nordisk Investigational Site | Bucharest | Romania | 020475 | |
| 157 | Novo Nordisk Investigational Site | Barnaul | Russian Federation | 656043 | |
| 158 | Novo Nordisk Investigational Site | Ekaterinburg | Russian Federation | 620102 | |
| 159 | Novo Nordisk Investigational Site | Kazan | Russian Federation | 420012 | |
| 160 | Novo Nordisk Investigational Site | Kazan | Russian Federation | 420061 | |
| 161 | Novo Nordisk Investigational Site | Moscow | Russian Federation | 117292 | |
| 162 | Novo Nordisk Investigational Site | Saint-Petersburg | Russian Federation | 194354 | |
| 163 | Novo Nordisk Investigational Site | Saint-Petersburg | Russian Federation | 196084 | |
| 164 | Novo Nordisk Investigational Site | Saint-Petersburg | Russian Federation | 197110 | |
| 165 | Novo Nordisk Investigational Site | Saratov | Russian Federation | 410031 | |
| 166 | Novo Nordisk Investigational Site | Saratov | Russian Federation | 410039 | |
| 167 | Novo Nordisk Investigational Site | Belgrade | Serbia | 11000 | |
| 168 | Novo Nordisk Investigational Site | Belgrade | Serbia | 11080 | |
| 169 | Novo Nordisk Investigational Site | Nis | Serbia | 18000 | |
| 170 | Novo Nordisk Investigational Site | Novi Sad | Serbia | 21000 | |
| 171 | Novo Nordisk Investigational Site | Bratislava | Slovakia | 82606 | |
| 172 | Novo Nordisk Investigational Site | Bratislava | Slovakia | 833 05 | |
| 173 | Novo Nordisk Investigational Site | Zilina | Slovakia | 01001 | |
| 174 | Novo Nordisk Investigational Site | Barcelona | Spain | 08035 | |
| 175 | Novo Nordisk Investigational Site | Hospitalet de Llobregat | Spain | 08907 | |
| 176 | Novo Nordisk Investigational Site | La Coruña | Spain | 15006 | |
| 177 | Novo Nordisk Investigational Site | Pamplona | Spain | 31008 | |
| 178 | Novo Nordisk Investigational Site | Sevilla | Spain | 41009 | |
| 179 | Novo Nordisk Investigational Site | Valencia | Spain | 46026 | |
| 180 | Novo Nordisk Investigational Site | London | United Kingdom | SE5 9RS | |
| 181 | Novo Nordisk Investigational Site | Norfolk | United Kingdom | NR4 7UQ | |
| 182 | Novo Nordisk Investigational Site | North Yorkshire | United Kingdom | HG2 7SX | |
| 183 | Novo Nordisk Investigational Site | Nottingham | United Kingdom | NG7 2UH | |
| 184 | Novo Nordisk Investigational Site | Nuneaton | United Kingdom | CV10 7DJ | |
| 185 | Novo Nordisk Investigational Site | Somerset | United Kingdom | BA21 4AT | |
| 186 | Novo Nordisk Investigational Site | Truro | United Kingdom | TR1 3LJ |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT03811561
Other Study ID Numbers:
- NN9535-4352
- U1111-1201-6256
- 2017-003619-20
First Posted:
Jan 22, 2019
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: