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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

Tracking Information
First Submitted Date  ICMJE November 10, 2015
First Posted Date  ICMJE November 18, 2015
Last Update Posted Date August 8, 2019
Actual Study Start Date  ICMJE February 15, 2016
Actual Primary Completion Date February 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
Change in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 26 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02607865 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
  • Change in body weight (kg) [ Time Frame: Week 0, week 26 ]
  • Change in FPG (fasting plasma glucose) [ Time Frame: Week 0, week 26 ]
  • Subjects who achieve HbA1c below 7.0% (53 mmol/mol), American Diabetes Association (ADA) target (yes/no) [ Time Frame: At week 26 ]
  • Subjects who achieve HbA1c below 7.0% (53 mmol/mol), American Diabetes Association (ADA) target (yes/no) [ Time Frame: At week 52 ]
  • Subjects who achieve HbA1c below 7.0% (53 mmol/mol), American Diabetes Association (ADA) target (yes/no) [ Time Frame: At week 78 ]
  • Change in HbA1c [ Time Frame: Week 0, Week 52 ]
  • Change in HbA1c [ Time Frame: Week 0, Week 78 ]
  • Change in body weight (kg) [ Time Frame: Week 0, Week 52 ]
  • Change in body weight (kg) [ Time Frame: Week 0, Week 78 ]
  • Change in FPG [ Time Frame: Week 0, Week 52 ]
  • Change in FPG [ Time Frame: Week 0, Week 78 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes
Official Title  ICMJE Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: semaglutide
    Oral administration once-daily
  • Drug: sitagliptin
    Oral administration once-daily
  • Drug: placebo
    Oral administration once-daily
Study Arms  ICMJE
  • Experimental: Semaglutide 3 mg
    Interventions:
    • Drug: semaglutide
    • Drug: placebo
  • Experimental: Semaglutide 7 mg
    Interventions:
    • Drug: semaglutide
    • Drug: placebo
  • Experimental: Semaglutide 14 mg
    Interventions:
    • Drug: semaglutide
    • Drug: placebo
  • Active Comparator: Sitagliptin 100 mg
    Interventions:
    • Drug: sitagliptin
    • Drug: placebo
Publications * Rosenstock J, Allison D, Birkenfeld AL, Blicher TM, Deenadayalan S, Jacobsen JB, Serusclat P, Violante R, Watada H, Davies M; PIONEER 3 Investigators. Effect of Additional Oral Semaglutide vs Sitagliptin on Glycated Hemoglobin in Adults With Type 2 Diabetes Uncontrolled With Metformin Alone or With Sulfonylurea: The PIONEER 3 Randomized Clinical Trial. JAMA. 2019 Apr 16;321(15):1466-1480. doi: 10.1001/jama.2019.2942.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2019)
1872
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2015)
1860
Actual Study Completion Date  ICMJE March 28, 2018
Actual Primary Completion Date February 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   France,   Germany,   India,   Israel,   Japan,   Mexico,   Romania,   Russian Federation,   South Africa,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02607865
Other Study ID Numbers  ICMJE NN9924-4222
2015-001351-71 ( EudraCT Number )
U1111-1168-4339 ( Other Identifier: WHO )
JAPIC ( Other Identifier: JapicCTI-163174 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novo Nordisk A/S
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP