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Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes (PIONEER 3)

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ClinicalTrials.gov Identifier: NCT02607865
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted globally. The aim of the trial is to investigate efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1872 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes
Actual Study Start Date : February 15, 2016
Actual Primary Completion Date : February 14, 2017
Actual Study Completion Date : March 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Semaglutide 3 mg Drug: semaglutide
Oral administration once-daily

Drug: placebo
Oral administration once-daily

Experimental: Semaglutide 7 mg Drug: semaglutide
Oral administration once-daily

Drug: placebo
Oral administration once-daily

Experimental: Semaglutide 14 mg Drug: semaglutide
Oral administration once-daily

Drug: placebo
Oral administration once-daily

Active Comparator: Sitagliptin 100 mg Drug: sitagliptin
Oral administration once-daily

Drug: placebo
Oral administration once-daily




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

Secondary Outcome Measures :
  1. Change in body weight (kg) [ Time Frame: Week 0, week 26 ]
  2. Change in FPG (fasting plasma glucose) [ Time Frame: Week 0, week 26 ]
  3. Subjects who achieve HbA1c below 7.0% (53 mmol/mol), American Diabetes Association (ADA) target (yes/no) [ Time Frame: At week 26 ]
  4. Subjects who achieve HbA1c below 7.0% (53 mmol/mol), American Diabetes Association (ADA) target (yes/no) [ Time Frame: At week 52 ]
  5. Subjects who achieve HbA1c below 7.0% (53 mmol/mol), American Diabetes Association (ADA) target (yes/no) [ Time Frame: At week 78 ]
  6. Change in HbA1c [ Time Frame: Week 0, Week 52 ]
  7. Change in HbA1c [ Time Frame: Week 0, Week 78 ]
  8. Change in body weight (kg) [ Time Frame: Week 0, Week 52 ]
  9. Change in body weight (kg) [ Time Frame: Week 0, Week 78 ]
  10. Change in FPG [ Time Frame: Week 0, Week 52 ]
  11. Change in FPG [ Time Frame: Week 0, Week 78 ]


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
Criteria

Inclusion Criteria:

  • Male or female, age at least 18 years at the time of signing informed consent For Japan only: Male or female, age at least 20 years at the time of signing informed consent
  • Diagnosed with T2DM (type 2 diabetes mellitus) for at least 90 days prior to day of screening
  • HbA1c (glycosylated haemoglobin) 7.0-10.5 % (53-91 mmol/mol) (both inclusive).
  • Stable daily dose of metformin (equal or above 1500 mg or maximum tolerated dose as documented in subject medical record) alone or in combination with SU (= half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) within 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 adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). For certain specific countries: Additional specific requirements apply
  • 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 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 hospitalization for unstable angina and/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 (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) below 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
  • History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)

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 ClinicalTrials.gov identifier (NCT number): NCT02607865


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Sponsors and Collaborators
Novo Nordisk A/S

Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02607865     History of Changes
Other Study ID Numbers: NN9924-4222
2015-001351-71 ( EudraCT Number )
U1111-1168-4339 ( Other Identifier: WHO )
JAPIC ( Other Identifier: JapicCTI-163174 )
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action