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Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation Versus Sitagliptin in Subjects With Type 2 Diabetes Mellitus. (PIONEER 7)

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Novo Nordisk

Status and phase

Completed
Phase 3

Conditions

Diabetes
Diabetes Mellitus, Type 2

Treatments

Drug: semaglutide
Drug: sitagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02849080
U1111-1177-5103 (Other Identifier)
2015-005593-38 (EudraCT Number)
NN9924-4257

Details and patient eligibility

About

This trial is globally conducted. The aim of this trial is to investigate Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation versus Sitagliptin in Subjects with Type 2 Diabetes Mellitus.

Enrollment

504 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Main phase (the inclusion criteria for the main phase are not reassessed for the extension phase):

  • 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 Korea only: Male or female, age above or equal to 19 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) 7.5-9.5% (58-80 mmol/mol) (both inclusive)
  • Treatment target of HbA1c below 7.0% (53 mmol/mol), as judged by the investigator
  • Stable daily dose(s) of 1-2 of the following anti-diabetic drugs within 90 days prior to the day of screening:
  • Metformin (equal or above 1500 mg or maximum tolerated dose as documented in the subject medical record)
  • Sulfonylureas (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)
  • Sodium glucose co-transporter 2 inhibitors
  • Thiazolidinediones (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)

Extension phase:

  • Informed consent for the extension phase obtained before any trial-related activities for the extension phase.
  • On randomised treatment with or without rescue medication at week 52.

Exclusion criteria

Main phase (the exclusion criteria for the main phase are not reassessed for the extension phase):

  • 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
  • Renal impairment defined as Estimated Glomerular Filtration rate 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula
  • 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

Extension phase: There are no new exclusion criteria for the extension phase

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

504 participants in 2 patient groups

Semaglutide flexible dosing (3, 7 or 14 mg)
Experimental group
Treatment:
Drug: semaglutide
Sitagliptin 100 mg
Active Comparator group
Treatment:
Drug: sitagliptin

Trial documents
2

Trial contacts and locations

83

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Data sourced from clinicaltrials.gov

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