Clinical trial NCT02692716: A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes
Official title: A Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-02-26
Enrollment: 3183
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted globally. The aim of the trial is to investigate the cardiovascular safety of oral semaglutide in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male or female diagnosed with type 2 diabetes
* Age at least 50 years at screening and presence of cardiovascular disease, or age at least 60 years at screening and presence of at least one cardiovascular risk factor

Exclusion Criteria:

* Current or previous (within 90 days prior to screening) treatment with any GLP-1 (glucagon-like peptide-1) receptor agonist, DPP-4 (dipeptidyl peptidase-4) inhibitor or pramlintide
* Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)
* History of pancreatitis (acute or chronic)
* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV heart failure
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening
* Chronic or intermittent hemodialysis or peritoneal dialysis or severe renal impairment (corresponding to eGFR (glomerular filtration rate, estimated) below 30 mL/min/1.73 m\^2)
* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)

Primary outcomes:
measure: Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke
timeFrame: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
Secondary outcomes:
measure: Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, UAP Requiring Hospitalisation or Hospitalisation for Heart Failure
timeFrame: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
measure: Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint
timeFrame: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
measure: Time From Randomisation to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, Non-fatal Myocardial Infarction or Nonfatal Stroke
timeFrame: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
measure: Time From Randomisation to First Occurrence of Fatal or Non-fatal Myocardial Infarction
timeFrame: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
measure: Time From Randomisation to First Occurrence of Fatal or Non-fatal Stroke
timeFrame: Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.
measure: Time From Randomisation to All-cause Death
timeFrame: Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 5 weeks of follow-up period.
measure: Time to First AE Leading to Permanent Trial Product Discontinuation
timeFrame: Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.
measure: Number of Serious Adverse Events
timeFrame: Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.
measure: Change in Eye Examination Category
timeFrame: Week -3, End of treatment
measure: Change in Pulse Rate
timeFrame: Week 0, End of treatment
measure: Change in Systolic and Diastolic Blood Pressure
timeFrame: Week 0, End of treatment
measure: Change in Glycosylated Haemoglobin (HbA1c)
timeFrame: Week 0, End of treatment
measure: Change in Body Weight
timeFrame: Week 0, End of treatment
measure: Change in Total Cholesterol - Ratio to Baseline
timeFrame: Week 0, End of treatment
measure: Change in LDL-cholesterol - Ratio to Baseline
timeFrame: Week 0, End of treatment
measure: Change in HDL-cholesterol - Ratio to Baseline
timeFrame: Week 0, End of treatment
measure: Change in Triglycerides - Ratio to Baseline
timeFrame: Week 0, End of treatment
Other outcomes:
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city: Searcy
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city: Chattanooga
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city: Kingsport
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city: Knoxville
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city: Nashville
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city: Nashville
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city: Arlington
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city: Austin
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city: Austin
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city: Austin
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state: Texas
city: Dallas
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state: Texas
city: Dallas
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state: Texas
city: Dallas
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state: Texas
city: Hurst
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city: Round Rock
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city: San Antonio
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city: Waco
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city: Norfolk
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state: Virginia
city: Winchester
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state: Virginia
city: Annaba
country: Algeria
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city: Edmonton
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country: Malaysia
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city: Kota Bharu
country: Malaysia
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city: Kota Samarahan
country: Malaysia
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city: Kuala Lumpur
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country: Mexico
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country: Poland
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facility: Novo Nordisk Investigational Site
state: Mures
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
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country: Romania
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city: Galati
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country: South Africa
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state: Free State
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city: Johannesburg
country: South Africa
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state: Gauteng
city: Lenasia
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city: Cape Town
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state: Western Cape
city: Alcala de Henares
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city: Badalona
country: Spain
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city: Fuenlabrada - Madrid
country: Spain
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city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
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country: Spain
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country: Spain
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city: Pontevedra
country: Spain
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city: Sevilla
country: Spain
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city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Kaohsiung City
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Taichung City
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Tainan city
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Taipei
country: Taiwan
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Chiang Mai
country: Thailand
facility: Novo Nordisk Investigational Site
city: Klong Luang, Pathumthani
country: Thailand
facility: Novo Nordisk Investigational Site
city: Nakhon Ratchasima
country: Thailand
facility: Novo Nordisk Investigational Site
city: Ankara
country: Turkey
facility: Novo Nordisk Investigational Site
city: Ankara
country: Turkey
facility: Novo Nordisk Investigational Site
city: Antalya
country: Turkey
facility: Novo Nordisk Investigational Site
city: Aydin
country: Turkey
facility: Novo Nordisk Investigational Site
city: Denizli
country: Turkey
facility: Novo Nordisk Investigational Site
city: Gaziantep
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Izmir
country: Turkey
facility: Novo Nordisk Investigational Site
city: Izmir
country: Turkey
facility: Novo Nordisk Investigational Site
city: Rize
country: Turkey
facility: Novo Nordisk Investigational Site
city: Aberdeen
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bristol
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Dundee
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Edinburgh
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Exeter
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Guildford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Norfolk
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Swansea
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Watford
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Cefalu WT, Kaul S, Gerstein HC, Holman RR, Zinman B, Skyler JS, Green JB, Buse JB, Inzucchi SE, Leiter LA, Raz I, Rosenstock J, Riddle MC. Cardiovascular Outcomes Trials in Type 2 Diabetes: Where Do We Go From Here? Reflections From a Diabetes Care Editors' Expert Forum. Diabetes Care. 2018 Jan;41(1):14-31. doi: 10.2337/dci17-0057.
citation: Bain SC, Mosenzon O, Arechavaleta R, Bogdanski P, Comlekci A, Consoli A, Deerochanawong C, Dungan K, Faingold MC, Farkouh ME, Franco DR, Gram J, Guja C, Joshi P, Malek R, Merino-Torres JF, Nauck MA, Pedersen SD, Sheu WH, Silver RJ, Tack CJ, Tandon N, Jeppesen OK, Strange M, Thomsen M, Husain M. Cardiovascular safety of oral semaglutide in patients with type 2 diabetes: Rationale, design and patient baseline characteristics for the PIONEER 6 trial. Diabetes Obes Metab. 2019 Mar;21(3):499-508. doi: 10.1111/dom.13553. Epub 2018 Nov 11.
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