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Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment

NCT ID: NCT02827708

Last Updated: 2020-02-17

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-20

Study Completion Date

2018-05-15

Brief Summary

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This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes and moderate renal impairment.

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Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Semaglutide

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Oral administration once daily.

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Oral administration once daily.

Interventions

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semaglutide

Oral administration once daily.

Intervention Type DRUG

placebo

Oral administration once daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male or female, age above or equal to 18 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening
* HbA1c (glycosylated haemoglobin) of 7.0-9.5% (53-80 mmol/mol) (both inclusive)
* Moderate renal impairment defined as estimated glomerular filtration rate of 30-59 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula
* Stable daily dose(s) within 90 days prior to the day of screening of any of the following treatment regimens:
* 1-2 of the following oral anti-diabetic drugs:
* Metformin equal or above 1500 mg or maximum tolerated dose documented in the subject medical record),
* Sulfonylurea (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)
* Basal insulin alone (20% change in total daily dose of insulin glargine, insulin detemir, insulin degludec or NPH insulin) or
* Metformin (equal or above 1500 mg or maximum tolerated dose documented in the subject medical record) in combination with basal insulin (20% change in total daily dose of insulin glargine, insulin detemir, insulin degludec or NPH insulin)

* Known hypoglycaemic unawareness and/or recurrent severe hypoglycaemic episodes as judged by the investigator
* Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation
* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)

Exclusion Criteria

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). For certain specific countries: Additional specific requirements apply
* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
* Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma
* 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)
* Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation
* Subjects presently classified as being in New York Heart Association Class IV
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* Subjects with alanine aminotransferase above 2.5 x upper normal limit
* Rapidly progressing renal disease (e.g. such as acute glomerulonephritis) as judged by the investigator or known nephrotic albuminuria (above 2200 mg/24 hours or above 2200 mg/g)
* Use of systemic immunosuppressive treatment within 90 days prior to screening
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novo Nordisk Investigational Site

Tuscumbia, Alabama, United States

Site Status

Novo Nordisk Investigational Site

Bermuda Dunes, California, United States

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Concord, California, United States

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Costa Mesa, California, United States

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Fresno, California, United States

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La Jolla, California, United States

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San Ramon, California, United States

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Danbury, Connecticut, United States

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Norwalk, Connecticut, United States

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Waterbury, Connecticut, United States

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Clearwater, Florida, United States

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Cooper City, Florida, United States

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Jacksonville, Florida, United States

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Miami Lakes, Florida, United States

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New Port Richey, Florida, United States

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Orlando, Florida, United States

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Palm Harbor, Florida, United States

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Pembroke Pines, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Lawrenceville, Georgia, United States

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Marietta, Georgia, United States

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Roswell, Georgia, United States

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Gurnee, Illinois, United States

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Avon, Indiana, United States

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Franklin, Indiana, United States

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Slidell, Louisiana, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Buckley, Michigan, United States

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Omaha, Nebraska, United States

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Lebanon, New Hampshire, United States

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Nashua, New Hampshire, United States

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Teaneck, New Jersey, United States

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Albany, New York, United States

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New Hyde Park, New York, United States

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Northport, New York, United States

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West Seneca, New York, United States

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Asheboro, North Carolina, United States

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Whiteville, North Carolina, United States

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Wilmington, North Carolina, United States

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Fargo, North Dakota, United States

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Dayton, Ohio, United States

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Delaware, Ohio, United States

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Franklin, Ohio, United States

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Norman, Oklahoma, United States

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Murrells Inlet, South Carolina, United States

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Myrtle Beach, South Carolina, United States

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Kingsport, Tennessee, United States

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Amarillo, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Midland, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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Winchester, Virginia, United States

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Winchester, Virginia, United States

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Olympia, Washington, United States

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Aalborg, , Denmark

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Århus C, , Denmark

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Gentofte Municipality, , Denmark

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Hvidovre, , Denmark

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København S, , Denmark

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Køge, , Denmark

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Svendborg, , Denmark

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Ähtäri, , Finland

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Espoo, , Finland

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Helsinki, , Finland

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Kerava, , Finland

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Kuopio, , Finland

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Oulu, , Finland

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Turku, , Finland

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Haifa, , Israel

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Haifa, , Israel

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Jerusalem, , Israel

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Kfar Saba, , Israel

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Rehovot, , Israel

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Poznan, , Poland

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Zabrze, , Poland

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Barnaul, , Russia

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Barnaul, , Russia

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Belgorod, , Russia

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Chelyabinsk, , Russia

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Dzerzhinskiy, , Russia

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Kazan', , Russia

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Moscow, , Russia

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Penza, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Saratov, , Russia

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Tomsk, , Russia

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Ulyanovsk, , Russia

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Volgograd, , Russia

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Voronezh, , Russia

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Yaroslavl, , Russia

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Yoshkar-Ola, , Russia

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Gothenburg, , Sweden

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Lund, , Sweden

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Örebro, , Sweden

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Skövde, , Sweden

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Uppsala, , Sweden

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Vindeln, , Sweden

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Bexhill-on-Sea, , United Kingdom

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Doncaster, , United Kingdom

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Edinburgh, , United Kingdom

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Glasgow, , United Kingdom

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Hull, , United Kingdom

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Milton Keynes, , United Kingdom

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Rothwell, , United Kingdom

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Sheffield, , United Kingdom

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Wellingborough, , United Kingdom

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Countries

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United States Denmark Finland Israel Poland Russia Sweden United Kingdom

References

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Mosenzon O, Blicher TM, Rosenlund S, Eriksson JW, Heller S, Hels OH, Pratley R, Sathyapalan T, Desouza C; PIONEER 5 Investigators. Efficacy and safety of oral semaglutide in patients with type 2 diabetes and moderate renal impairment (PIONEER 5): a placebo-controlled, randomised, phase 3a trial. Lancet Diabetes Endocrinol. 2019 Jul;7(7):515-527. doi: 10.1016/S2213-8587(19)30192-5. Epub 2019 Jun 9.

Reference Type RESULT
PMID: 31189517 (View on PubMed)

Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

Reference Type DERIVED
PMID: 39963952 (View on PubMed)

Mosenzon O, Capehorn MS, De Remigis A, Rasmussen S, Weimers P, Rosenstock J. Impact of semaglutide on high-sensitivity C-reactive protein: exploratory patient-level analyses of SUSTAIN and PIONEER randomized clinical trials. Cardiovasc Diabetol. 2022 Sep 2;21(1):172. doi: 10.1186/s12933-022-01585-7.

Reference Type DERIVED
PMID: 36056351 (View on PubMed)

Pratley RE, Crowley MJ, Gislum M, Hertz CL, Jensen TB, Khunti K, Mosenzon O, Buse JB. Oral Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses. Diabetes Ther. 2021 Apr;12(4):1099-1116. doi: 10.1007/s13300-020-00994-9. Epub 2021 Mar 4.

Reference Type DERIVED
PMID: 33660198 (View on PubMed)

Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

Reference Type DERIVED
PMID: 32998732 (View on PubMed)

Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13.

Reference Type DERIVED
PMID: 32267058 (View on PubMed)

Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

Reference Type DERIVED
PMID: 31903692 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2015-005326-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1176-9230

Identifier Type: OTHER

Identifier Source: secondary_id

NN9924-4234

Identifier Type: -

Identifier Source: org_study_id

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