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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 21, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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
Diabetes Mellitus, Type 2 Drug: Semaglutide Drug: Placebo (semaglutide) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : February 5, 2025
Estimated Study Completion Date : May 21, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

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).




Primary Outcome Measures :
  1. Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).


Secondary Outcome Measures :
  1. 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.

  2. Change in visual acuity in the worse seeing eye. [ Time Frame: Week 0, Year 5 ]
    Measured in number of letters using the ETDRS protocol.

  3. Change in visual acuity in the better seeing eye. [ Time Frame: Week 0, Year 5 ]
    Measured in number of letters using the ETDRS protocol.

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. Presence of at least 3 steps ETDRS subject level improvement. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).

  10. Presence of at least 2 steps ETDRS subject level progression. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).

  11. Presence of at least 2 steps ETDRS subject level improvement. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).

  12. Presence of persistent visual acuity up to 38 ETDRS letters in either eye. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. Presence of ciDME in either eye. [ Time Frame: Year 5 ]
    Percentage of subjects (yes/no).

  18. Change in glycosylated haemoglobin (HbA1c). [ Time Frame: Week 0, Year 5 ]
    Measured in %-points.

  19. Change in body weight. [ Time Frame: Week 0, Year 5 ]
    Measured in kg.

  20. Change in systolic and diastolic blood pressure. [ Time Frame: Week 0, Year 5 ]
    Measured in mmHg.

  21. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 greater than or equal to 10 years prior to the day of screening
  • 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 twelve months prior to the day of screening
  • No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within six 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
  • Current or previous (within 30 days before screening) treatment with any glucagon like peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase-4 (DPP-4) inhibitor
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811561


Contacts
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Contact: Novo Nordisk +1 866-867-7178 clinicaltrials@novonordisk.com

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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03811561     History of Changes
Other Study ID Numbers: NN9535-4352
U1111-1201-6256 ( Other Identifier: World Health Organization (WHO) )
2017-003619-20 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases