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Efficacy and Safety of Oral Semaglutide Versus Empagliflozin in Subjects With Type 2 Diabetes Mellitus (PIONEER 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02863328
Recruitment Status : Completed
First Posted : August 11, 2016
Last Update Posted : October 9, 2019
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted globally. The aim of this trial is to investigate Efficacy and Safety of Oral Semaglutide versus Empagliflozin in Subjects with Type 2 Diabetes Mellitus.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: semaglutide Drug: empagliflozin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 822 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Oral Semaglutide Versus Empagliflozin in Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date : August 10, 2016
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : March 8, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 14 mg oral semaglutide Drug: semaglutide
Oral administration once-daily.

Active Comparator: 25 mg empagliflozin Drug: empagliflozin
Oral administration once-daily.

Primary Outcome Measures :
  1. Change in glycosylated haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ]

Secondary Outcome Measures :
  1. Change in Body weight (kg) [ Time Frame: Week 0, Week 26, Week 52 ]
  2. Change in Fasting plasma glucose [ Time Frame: Week 0, Week 26, Week 52 ]
  3. HbA1c below 7.0 % (53 mmol/mol) [ Time Frame: At week 26 and 52 ]
  4. Number of treatment-emergent adverse events [ Time Frame: Weeks 0-57 ]
  5. Number of treatment-emergent severe symptomatic hypoglycaemic episodes [ Time Frame: Weeks 0-57 ]
  6. Number of treatment-emergent severe blood glucose-confirmed symptomatic hypoglycaemic episodes [ Time Frame: Weeks 0-57 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 at least 90 days prior to day of screening
  • HbA1c (glycosylated haemoglobin) of 7.0-10.5 % (53-91 mmol/mol) (both inclusive)
  • Stable daily dose of metformin (at least 1500 mg or maximum tolerated dose as documented in the subject medical record) at least 90 days prior to the day of screening

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
  • 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 ALT (alanine aminotransferase) above 2.5 x upper normal limit
  • Renal impairment defined as Estimated Glomerular Filtration Rate below 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 insulin treatment for acute illness for a total of below or equal to 14 days
  • 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)
  • History of diabetic ketoacidosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02863328

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Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S Identifier: NCT02863328     History of Changes
Other Study ID Numbers: NN9924-4223
2015-005209-36 ( EudraCT Number )
U1111-1176-6006 ( Other Identifier: World Health Organization (WHO) )
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs