FLOW: A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03819153
Collaborator
(none)
3,508
Enrollment
418
Locations
2
Arms
62.1
Anticipated Duration (Months)
8.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3508 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:
Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease
Actual Study Start Date :
Jun 17, 2019
Anticipated Primary Completion Date :
Aug 19, 2024
Anticipated Study Completion Date :
Aug 19, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: Semaglutide

Participants are to receive semglutide for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.

Drug: Semaglutide
Participants are to inject semaglutide with a needle in the stomach, thigh or upper arm. Participants will use a pen to inject semaglutide under their skin. Participants will inject semaglutide 1 time a week on the same day of the week. Participants' dose of semaglutide will be changed over time. Participants start by taking a smaller amount (0.25 mg). After 4 weeks the dose will be increased to 0.5 mg. It will be increased more (to 1 mg) at 8 weeks. Participants will then stay on the same dose for the rest of the study.

Placebo Comparator: Placebo

Participants are to receive placebo (semglutide) for up to 5 years or more (event driven). The trial is event driven with a pre-defined minimum number of renal endpoint events for the primary endpoint.

Drug: Placebo (semaglutide)
Participants are to inject placebo (semaglutide) with a needle in the stomach, thigh or upper arm. Participants will use a pen to inject placebo (semaglutide) under their skin. Participants will inject placebo (semaglutide) 1 time a week on the same day of the week. Participants' dose of placebo (semaglutide) will be changed over time. Participants start by taking a smaller amount (0.25 mg). After 4 weeks the dose will be increased to 0.5 mg. It will be increased more (to 1 mg) at 8 weeks. Participants will then stay on the same dose for the rest of the study.

Outcome Measures

Primary Outcome Measures

  1. Time to first occurrence of a composite primary outcome event defined as persistent eGFR decline of greater than or equal to 50 percentage from trial start, reaching ESRD, death from kidney disease or death from cardiovascular disease [Week 0 to month 61]

    Measured in month(s). End Stage Renal Disease (ESRD) is defined as the following individual components: Persistent estimated glomerular filtration rate (eGFR) less than 15 mL/min/1.73m^2 or, Chronic dialysis treatment or receiving a kidney transplantation.

Secondary Outcome Measures

  1. Annual rate of change in eGFR (chronic kidney disease - epidemiology collaboration (CKD-EPI)) (total eGFR slope) [Week 0 to month 61]

    Measured in (mL/min/1.73 m^2)/year.

  2. Time to first occurrence of a composite cardiovascular major adverse cardiovascular event (MACE) endpoint consisting of: Non-fatal myocardial infarction, non-fatal stroke, and cardiovascular (CV) death [Week 0 to month 61]

    Measured in month(s).

  3. Time to occurrence of all-cause death [Week 0 to month 61]

    Measured in month(s).

  4. Time to occurrence of each of the individual components of the primary composite endpoint and of the confirmatory secondary MACE endpoint [Week 0 to month 61]

    Measured in month(s).

  5. Time to first occurrence of major adverse limb events (MALE), a composite endpoint consisting of: Acute limb ischemia hospitalisation and chronic limb ischemia hospitalisation [Week 0 to month 61]

    Measured in month(s).

  6. Annual rate of change in eGFR (CKD-EPI) (chronic eGFR slope) [Week 12 to month 61]

    Measured in (mL/min/1.73 m^2)/year.

  7. Change in eGFR (CKD-EPI) [Week 0, Week 12]

    Measured in mL/min/1.73 m^2.

  8. Change in eGFR (cystatin C CKD-EPI) [Week 0, Year 3]

    Measured in mL/min/1.73 m^2.

  9. Relative change in urinary albumin-to-creatinine ratio (UACR) [Week 0, Year 3]

    Measured in percentage.

  10. Change in body weight [Week 0, Year 3]

    Measured in kilogram.

  11. Change in glycosylated haemoglobin (HbA1c) [Week 0, Year 3]

    Measured in percentage point.

  12. Change in systolic blood pressure [Week 0, Year 3]

    Measured in mmHg.

  13. Change in diastolic blood pressure [Week 0, Year 3]

    Measured in mmHg.

  14. Number of severe hypoglycaemic episodes [Week 0 to month 61]

    Number of events.

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 above or equal to 18 years at the time of signing informed consent. Japan: Male or female, age above or equal to 20 years at the time of signing informed consent

  • Diagnosed with type 2 diabetes mellitus

  • HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol)

  • Renal impairment defined either by:

  1. serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or

  2. serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g

  • Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening
Exclusion Criteria:
  • Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations

  • Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to screening

  • Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening

  • Presently classified as being in New York Heart Association (NYHA) Class IV heart failure

  • Planned coronary, carotid or peripheral artery revascularisation

  • Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to 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

Contacts and Locations

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317Novo Nordisk Investigational SiteAlmereNetherlands1311RL
318Novo Nordisk Investigational SiteAmersfoortNetherlands3813 TZ
319Novo Nordisk Investigational SiteAmsterdamNetherlands1061 AE
320Novo Nordisk Investigational SiteAmsterdamNetherlands1081 HV
321Novo Nordisk Investigational SiteArnhemNetherlands6815 AD
322Novo Nordisk Investigational SiteHilversumNetherlands1213 XZ
323Novo Nordisk Investigational SiteUtrechtNetherlands3584 CX
324Novo Nordisk Investigational SiteBialystokPoland15-351
325Novo Nordisk Investigational SiteKielcePoland25-035
326Novo Nordisk Investigational SiteOlsztynPoland10-561
327Novo Nordisk Investigational SitePoznanPoland60-355
328Novo Nordisk Investigational SitePoznanPoland60-589
329Novo Nordisk Investigational SiteRadomPoland26-600
330Novo Nordisk Investigational SiteSzczecinPoland70-111
331Novo Nordisk Investigational SiteWarszawaPoland01-192
332Novo Nordisk Investigational SiteWarszawaPoland04-749
333Novo Nordisk Investigational SiteZabrzePoland41-800
334Novo Nordisk Investigational SiteBarnaulRussian Federation656024
335Novo Nordisk Investigational SiteBarnaulRussian Federation656045
336Novo Nordisk Investigational SiteChelyabinskRussian Federation454048
337Novo Nordisk Investigational SiteKazanRussian Federation420061
338Novo Nordisk Investigational SiteKemerovoRussian Federation650066
339Novo Nordisk Investigational SiteMoscowRussian Federation117036
340Novo Nordisk Investigational SiteNovosibirskRussian Federation630005
341Novo Nordisk Investigational SiteNovosibirskRussian Federation630099
342Novo Nordisk Investigational SitePenzaRussian Federation440026
343Novo Nordisk Investigational SiteSaint PetersburgRussian Federation191014
344Novo Nordisk Investigational SiteSaint PetersburgRussian Federation194156
345Novo Nordisk Investigational SiteSaint-PetersburgRussian Federation190121
346Novo Nordisk Investigational SiteSaint-PetersburgRussian Federation194156
347Novo Nordisk Investigational SiteSaint-PetersburgRussian Federation194356
348Novo Nordisk Investigational SiteSamaraRussian Federation443031
349Novo Nordisk Investigational SiteSaratovRussian Federation410031
350Novo Nordisk Investigational SiteSaratovRussian Federation410039
351Novo Nordisk Investigational SiteStavropolRussian Federation355035
352Novo Nordisk Investigational SiteUlianovskRussian Federation432063
353Novo Nordisk Investigational SiteVoronezhRussian Federation394018
354Novo Nordisk Investigational SiteYaroslavlRussian Federation150003
355Novo Nordisk Investigational SiteYoshkar-OlaRussian Federation424004
356Novo Nordisk Investigational SiteBratislavaSlovakia851 01
357Novo Nordisk Investigational SiteKosiceSlovakia04011
358Novo Nordisk Investigational SiteLubochnaSlovakia03491
359Novo Nordisk Investigational SiteLucenecSlovakia984 01
360Novo Nordisk Investigational SiteNitraSlovakia94901
361Novo Nordisk Investigational SitePresovSlovakia08001
362Novo Nordisk Investigational SiteTrebisovSlovakia07501
363Novo Nordisk Investigational SiteTrstenaSlovakia02801
364Novo Nordisk Investigational SiteZilinaSlovakia010 01
365Novo Nordisk Investigational SiteZilinaSlovakia010 08
366Novo Nordisk Investigational SiteZilinaSlovakia01001
367Novo Nordisk Investigational SiteBloemfonteinFree StateSouth Africa9300
368Novo Nordisk Investigational SiteBenoniGautengSouth Africa1501
369Novo Nordisk Investigational SiteCosmo CityGautengSouth Africa2188
370Novo Nordisk Investigational SiteJohannesburgGautengSouth Africa1818
371Novo Nordisk Investigational SiteJohannesburgGautengSouth Africa1827
372Novo Nordisk Investigational SiteJohannesburgGautengSouth Africa2013
373Novo Nordisk Investigational SiteDurbanKwaZulu-NatalSouth Africa4092
374Novo Nordisk Investigational SiteCape TownWestern CapeSouth Africa7925
375Novo Nordisk Investigational SiteCape TownSouth Africa7530
376Novo Nordisk Investigational SiteBarcelonaSpain08003
377Novo Nordisk Investigational SiteBarcelonaSpain08035
378Novo Nordisk Investigational SiteBurelaSpain27880
379Novo Nordisk Investigational SiteGetafeSpain28905
380Novo Nordisk Investigational SiteValenciaSpain46010
381Novo Nordisk Investigational SiteValenciaSpain46017
382Novo Nordisk Investigational SiteBangkoknoi, BangkokThailand10700
383Novo Nordisk Investigational SiteBangkokThailand10330
384Novo Nordisk Investigational SiteBangkokThailand10400
385Novo Nordisk Investigational SiteBangkokThailand10700
386Novo Nordisk Investigational SiteChiang MaiThailand50200
387Novo Nordisk Investigational SiteAdanaTurkey01330
388Novo Nordisk Investigational SiteAnkaraTurkey06100
389Novo Nordisk Investigational SiteAnkaraTurkey06230
390Novo Nordisk Investigational SiteAnkaraTurkey06500
391Novo Nordisk Investigational SiteAntalyaTurkey07058
392Novo Nordisk Investigational SiteAydinTurkey09100
393Novo Nordisk Investigational SiteIstanbulTurkey34098
394Novo Nordisk Investigational SiteIstanbulTurkey34390
395Novo Nordisk Investigational SiteIstanbulTurkey34722
396Novo Nordisk Investigational SiteIstanbulTurkey34899
397Novo Nordisk Investigational SiteIzmirTurkey35100
398Novo Nordisk Investigational SiteKahramanmarasTurkey46040
399Novo Nordisk Investigational SiteKocaeliTurkey41380
400Novo Nordisk Investigational SiteDniproUkraine49000
401Novo Nordisk Investigational SiteIvano-FrankivskUkraine76008
402Novo Nordisk Investigational SiteKharkivUkraine61002
403Novo Nordisk Investigational SiteKharkivUkraine61039
404Novo Nordisk Investigational SiteKyivUkraine04114
405Novo Nordisk Investigational SitePoltavaUkraine36039
406Novo Nordisk Investigational SiteZaporizhiaUkraine69001
407Novo Nordisk Investigational SiteZaporizhiaUkraine69600
408Novo Nordisk Investigational SiteAberdeenUnited KingdomAB25 2ZN
409Novo Nordisk Investigational SiteBirminghamUnited KingdomB9 5SS
410Novo Nordisk Investigational SiteCardiffUnited KingdomCF5 4AD
411Novo Nordisk Investigational SiteDundeeUnited KingdomDD1 9SY
412Novo Nordisk Investigational SiteEdinburghUnited KingdomEH4 2XU
413Novo Nordisk Investigational SiteGlasgowUnited KingdomG31 2ER
414Novo Nordisk Investigational SiteIpswichUnited KingdomIP4 5PD
415Novo Nordisk Investigational SiteLondonUnited KingdomN18 1QX
416Novo Nordisk Investigational SiteLondonUnited KingdomNW3 2QG
417Novo Nordisk Investigational SiteStevenageUnited KingdomSG1 4AB
418Novo Nordisk Investigational SiteTootingUnited KingdomSW17 0RE

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 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:
NCT03819153
Other Study ID Numbers:
  • NN9535-4321
  • U1111-1217-6259
  • 2018-002878-50
  • JapicCTI-194843
First Posted:
Jan 28, 2019
Last Update Posted:
Nov 29, 2021
Last Verified:
Nov 1, 2021
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:

Study Results

No Results Posted as of Nov 29, 2021