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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)

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ClinicalTrials.gov Identifier: NCT03811561
Recruitment Status : Recruiting
First Posted : January 22, 2019
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE January 18, 2019
First Posted Date  ICMJE January 22, 2019
Last Update Posted Date November 12, 2020
Actual Study Start Date  ICMJE May 8, 2019
Estimated Primary Completion Date July 13, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression. [ Time Frame: Year 5 ]
Percentage of subjects (yes/no).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2019)
  • Time from randomisation to first at least 3 steps ETDRS subject level progression or central involved diabetic macular oedema (ciDME) in either eye. [ Time Frame: Up to 5 years ]
    Measured in months.
  • Change in visual acuity in the worse seeing eye. [ Time Frame: Week 0, Year 5 ]
    Measured in number of letters using the ETDRS protocol.
  • Change in visual acuity in the better seeing eye. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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). [ Time Frame: 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. [ Time Frame: Week 0-Year 5 ]
    Percentage of subjects (yes/no).
  • Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with vitrectomy. [ Time Frame: Week 0-Year 5 ]
    Percentage of subjects (yes/no).
  • Presence of at least 3 steps ETDRS subject level improvement. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).
  • Presence of at least 2 steps ETDRS subject level progression. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).
  • Presence of at least 2 steps ETDRS subject level improvement. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).
  • Presence of persistent visual acuity up to 38 ETDRS letters in either eye. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).
  • Persistent at least 3 lines (15 letters) ETDRS improvement in visual acuity in either eye from baseline. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).
  • Presence of ciDME in either eye. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).
  • Change in glycosylated haemoglobin (HbA1c). [ Time Frame: Week 0, Year 5 ]
    Measured in %-points.
  • Change in body weight. [ Time Frame: Week 0, Year 5 ]
    Measured in kg.
  • Change in systolic and diastolic blood pressure. [ Time Frame: Week 0, Year 5 ]
    Measured in mmHg.
  • Change in Lipids: Total-cholesterol, High density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol and triglycerides. [ Time Frame: Week 0, Year 5 ]
    Measured in mmol/L
Original Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
  • Time from randomisation to first at least 3 steps ETDRS subject level progression or central involved diabetic macular oedema (ciDME) in either eye. [ Time Frame: Up to 5 years ]
    Measured in months.
  • Change in visual acuity in the worse seeing eye. [ Time Frame: Week 0, Year 5 ]
    Measured in number of letters using the ETDRS protocol.
  • Change in visual acuity in the better seeing eye. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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). [ Time Frame: 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. [ Time Frame: Week 0-Year 5 ]
    Percentage of subjects (yes/no).
  • Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with vitrectomy. [ Time Frame: Week 0-Year 5 ]
    Percentage of subjects (yes/no).
  • Presence of at least 3 steps ETDRS subject level improvement. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).
  • Presence of at least 2 steps ETDRS subject level progression. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).
  • Presence of at least 2 steps ETDRS subject level improvement. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).
  • Presence of persistent visual acuity up to 38 ETDRS letters in either eye. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).
  • Persistent at least 3 lines (15 letters) ETDRS improvement in visual acuity in either eye from baseline. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).
  • Presence of ciDME in either eye. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).
  • Change in glycosylated haemoglobin (HbA1c). [ Time Frame: Week 0, Year 5 ]
    Measured in %-points.
  • Change in body weight. [ Time Frame: Week 0, Year 5 ]
    Measured in kg.
  • Change in systolic and diastolic blood pressure. [ Time Frame: Week 0, Year 5 ]
    Measured in mmHg.
  • Change in Lipids: Total-cholesterol, High density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol and triglycerides. [ Time Frame: Week 0, Year 5 ]
    Meaured in mmol/L
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes
Official Title  ICMJE Long-term Effects of Semaglutide on Diabetic Retinopathy in Subjects With Type 2 Diabetes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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).
  • 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).
Study Arms  ICMJE
  • Experimental: Semaglutide
    Participants will receive semaglutide once weekly as subcutaneous (s.c., under the skin) injection added to standard of care.
    Intervention: Drug: Semaglutide
  • Placebo Comparator: Placebo
    Participants will receive placebo (semaglutide) once weekly as subcutaneous subcutaneous (s.c., under the skin) injection added to standard of care.
    Intervention: Drug: Placebo (semaglutide)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 18, 2019)
1500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 18, 2026
Estimated Primary Completion Date July 13, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novo Nordisk +1 866-867-7178 clinicaltrials@novonordisk.com
Listed Location Countries  ICMJE Brazil,   Bulgaria,   Canada,   Czechia,   Germany,   India,   Israel,   Latvia,   Mexico,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03811561
Other Study ID Numbers  ICMJE NN9535-4352
U1111-1201-6256 ( Other Identifier: World Health Organization (WHO) )
2017-003619-20 ( Registry Identifier: European Medicines Agency (EudraCT) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP