Overview

This trial is active, not recruiting.

Conditions diabetes, diabetes mellitus, type 2
Treatments semaglutide, sitagliptin, placebo
Phase phase 3
Sponsor Novo Nordisk A/S
Start date February 2016
End date March 2018
Trial size 1860 participants
Trial identifier NCT02607865, 2015-001351-71, JAPIC, NN9924-4222, U1111-1168-4339

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
semaglutide
Oral administration once-daily
placebo
Oral administration once-daily
(Experimental)
semaglutide
Oral administration once-daily
placebo
Oral administration once-daily
(Experimental)
semaglutide
Oral administration once-daily
placebo
Oral administration once-daily
(Active Comparator)
sitagliptin
Oral administration once-daily
placebo
Oral administration once-daily

Primary Outcomes

Measure
Change in HbA1c (glycosylated haemoglobin)
time frame: Week 0, week 26

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Novo Nordisk A/S.