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
331
mi
from 43215
Hyattsville, MD
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Anaheim, California 92801
1962
mi
from 43215
Anaheim, CA
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Anniston, Alabama 36207
462
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Anniston, AL
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Asheville, North Carolina 28801
302
mi
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Asheville, NC
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Atlanta, Georgia 30318
436
mi
from 43215
Atlanta, GA
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Austin, Texas 78731
1065
mi
from 43215
Austin, TX
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Beaver, Pennsylvania 15009
151
mi
from 43215
Beaver, PA
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Birmingham, Alabama 35215
481
mi
from 43215
Birmingham, AL
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Boston, Massachusetts 02115
641
mi
from 43215
Boston, MA
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Chapel Hill, North Carolina 27599
353
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Chapel Hill, NC
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Chattanooga, Tennessee 37404
362
mi
from 43215
Chattanooga, TN
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Chicago, Illinois 60612
274
mi
from 43215
Chicago, IL
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Cincinnati, Ohio 45229
95
mi
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Cincinnati, OH
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Colorado Springs, Colorado 80910
1161
mi
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Colorado Springs, CO
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Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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65
mi
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Dayton, OH
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Denver, Colorado 80220
1161
mi
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Denver, CO
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Fountain Hills, Arizona 85628
1639
mi
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Fountain Hills, AZ
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Franklin, Indiana 46131
114
mi
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Franklin, IN
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Fresno, California 93702
1988
mi
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Fresno, CA
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Glendale, Arizona 85306
1662
mi
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Glendale, AZ
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Henderson, Nevada 89052
1755
mi
from 43215
Henderson, NV
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Hialeah, Florida 33012
987
mi
from 43215
Hialeah, FL
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Houston, Texas 77030
995
mi
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Houston, TX
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Kingsport, Tennessee 37660
237
mi
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Kingsport, TN
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Lansdale, Pennsylvania 19446
409
mi
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Lansdale, PA
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Las Vegas, Nevada 89128
1762
mi
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Las Vegas, NV
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Lexington, Kentucky 40503
157
mi
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Lexington, KY
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Los Angeles, California 90027
1973
mi
from 43215
Los Angeles, CA
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Mesa, Arizona 85206
1650
mi
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Mesa, AZ
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Mesquite, Texas 75149
903
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Mesquite, TX
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Metairie, Louisiana 70002
796
mi
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Metairie, LA
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Midland, Texas 79707
1195
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Midland, TX
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1514
mi
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Murray, UT
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Natchitoches, Louisiana 71457
798
mi
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Natchitoches, LA
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Paducah, Kentucky 42003
361
mi
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Paducah, KY
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Phoenix, Arizona 85053
1662
mi
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Phoenix, AZ
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Riverside, California 92506
1929
mi
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Riverside, CA
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Rockville, Maryland 20852
320
mi
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Rockville, MD
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Round Rock, Texas 78681
1052
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Round Rock, TX
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Summerville, South Carolina 29485
505
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Summerville, SC
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Troy, Michigan 48098
303
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Troy, MI
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Tucson, Arizona 85704
1638
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Tucson, AZ
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Van Nuys, California 91405
1979
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Van Nuys, CA
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Vista, California 92083
1942
mi
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Vista, CA
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West Seneca, New York 14224
295
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West Seneca, NY
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Winchester, Virginia 22601
264
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Winchester, VA
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?
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Winnipeg,
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