Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:12/22/2018
Start Date:February 2, 2017
End Date:August 22, 2018

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Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin. A 52-week, Randomised, Double-blind, Placebo-controlled Trial (PIONEER 8 - Insulin add-on)

This trial is conducted globally. The aim of the trial is to investigate the efficacy and
safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated
with insulin. All subjects should continue their pre-trial insulin therapy (basal,
basal-bolus or premixed regimen including combinations of soluble insulins) throughout the
trial. Subjects treated with metformin in addition to insulin treatment must continue their
metformin treatment throughout the entire trial.


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. For Japan only: Male or female,
age above or equal to 20 years at the time of signing informed consent. - Diagnosed with
type 2 diabetes mellitus 90 days or more prior to the day of screening. - HbA1c
(glycosylated haemoglobin) of 7.0-9.5% (53-80 mmol/mol) (both inclusive). - Stable
treatment with one of the following insulin regimens (minimum 10 IU/day) 90 or more days
prior to the day of screening. Maximum 20% change in total daily dose is acceptable: (1)
Basal insulin alone or (2) Basal and bolus insulin in any combination or (3) Premixed
insulin including combinations of soluble insulins 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 Greece only: adequate contraceptive measures are defined
as combined hormonal contraception (containing oestrogen and progesterone), which suppress
ovulation (oral, intravaginal, percutaneous), progesterone-only hormonal contraception
which suppress ovulation (oral, injectable, implantable), intrauterine device,
hormone-releasing intrauterine system, bilateral tubal occlusion, partner with vasectomy,
sexual abstinence. For Japan only: Adequate contraceptive measures are abstinence (not
having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or
oral contraceptives. For Canada only: adequate contraceptive measures are defined as
combined hormonal contraception (containing oestrogen and progesterone), which suppress
ovulation (oral, intravaginal, percutaneous), progesterone-only hormonal contraception
which suppress ovulation (oral, injectable, implantable), intrauterine device,
hormone-releasing intrauterine system, bilateral tubal occlusion, partner with vasectomy,
sexual abstinence - 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 (MEN 2) or Medullary Thyroid Carcinoma (MTC). - History of
pancreatitis (acute or chronic). - History of major surgical procedures involving the
stomach and potentially affecting absorption of trial product (e.g. subtotal and total
gastrectomy, sleeve gastrectomy, gastric bypass surgery). - Any of the following:
myocardial infarction (MI), stroke or hospitalisation for unstable angina or transient
ischaemic attack within the past 180 days prior to the day of screening and randomisation.
- Classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary,
carotid or peripheral artery revascularisation known on the day of screening. - Renal
impairment defined as estimated Glomerular Filtration Rate (eGFR) less than 60 mL/min/1.73
m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI). - Treatment
with any medication for the indication of diabetes or obesity other than stated in the
inclusion criteria in a period of 90 days before the day of screening. An exception is
short-term change of insulin treatment for acute illness for a total of 14 days or less. -
Known hypoglycaemic unawareness according to Clarke's questionnaire. - 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). - Subjects with alanine aminotransferase (ALT) more than 2.5 x
upper normal limit (UNL).
We found this trial at
48
sites
Hyattsville, Maryland 20782
1131
mi
from
Hyattsville, MD
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Anaheim, California 92801
1157
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Anaheim, CA
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Anniston, Alabama 36207
728
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Anniston, AL
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Asheville, North Carolina 28801
857
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Asheville, NC
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Atlanta, Georgia 30318
801
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from
Atlanta, GA
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Austin, Texas 78731
517
mi
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Austin, TX
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Beaver, Pennsylvania 15009
957
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from
Beaver, PA
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Birmingham, Alabama 35215
684
mi
from
Birmingham, AL
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Boston, Massachusetts 02115
1442
mi
from
Boston, MA
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Chapel Hill, North Carolina 27599
1043
mi
from
Chapel Hill, NC
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Chattanooga, Tennessee 37404
721
mi
from
Chattanooga, TN
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Chicago, Illinois 60612
609
mi
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Chicago, IL
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Cincinnati, Ohio 45229
727
mi
from
Cincinnati, OH
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Colorado Springs, Colorado 80910
383
mi
from
Colorado Springs, CO
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Dallas, Texas 75231
341
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Dallas, TX
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744
mi
from
Dayton, OH
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Denver, Colorado 80220
409
mi
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Denver, CO
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Fountain Hills, Arizona 85628
829
mi
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Fountain Hills, AZ
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Franklin, Indiana 46131
695
mi
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Franklin, IN
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Fresno, California 93702
1205
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Fresno, CA
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Glendale, Arizona 85306
853
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Glendale, AZ
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Henderson, Nevada 89052
957
mi
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Henderson, NV
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Hialeah, Florida 33012
1313
mi
from
Hialeah, FL
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Houston, Texas 77030
572
mi
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Houston, TX
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Kingsport, Tennessee 37660
843
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Kingsport, TN
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Lansdale, Pennsylvania 19446
1219
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Lansdale, PA
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Las Vegas, Nevada 89128
967
mi
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Las Vegas, NV
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Lexington, Kentucky 40503
724
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Lexington, KY
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Los Angeles, California 90027
1169
mi
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Los Angeles, CA
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Mesa, Arizona 85206
840
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Mesa, AZ
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Mesquite, Texas 75149
351
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Mesquite, TX
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Metairie, Louisiana 70002
691
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Metairie, LA
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Midland, Texas 79707
464
mi
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Midland, TX
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778
mi
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Murray, UT
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Natchitoches, Louisiana 71457
493
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Natchitoches, LA
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Paducah, Kentucky 42003
507
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Paducah, KY
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Phoenix, Arizona 85053
852
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Phoenix, AZ
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Riverside, California 92506
1124
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Riverside, CA
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Rockville, Maryland 20852
1122
mi
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Rockville, MD
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Round Rock, Texas 78681
499
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Round Rock, TX
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Summerville, South Carolina 29485
1044
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Summerville, SC
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Troy, Michigan 48098
742
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Troy, MI
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Tucson, Arizona 85704
832
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Tucson, AZ
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Van Nuys, California 91405
1176
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Van Nuys, CA
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Vista, California 92083
1134
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Vista, CA
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West Seneca, New York 14224
1059
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West Seneca, NY
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Winchester, Virginia 22601
1065
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Winchester, VA
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?
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Winnipeg,
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