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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

semaglutide

empagliflozin

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

14 mg oral semaglutide

25 mg empagliflozin

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.

Secondary Outcome Measures

Change in Body Weight (Kg)

Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.

Change in HbA1c (%)

Change from baseline (week 0) in HbA1c was evaluated at week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Body Weight (kg)

Change from baseline (week 0) in body weight was evaluated at week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Fasting Plasma Glucose

Change from baseline (week 0) in fasting plasma glucose was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in SMPG : Mean of the 7-point Profile

Change from baseline (week 0) in mean of the 7-point self-measured plasma glucose (SMPG) (i.e. before and after breakfast, lunch and dinner, and at bedtime) profile was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in SMPG : Mean Postprandial Increment Over All Meals

Change from baseline (week 0) in mean postprandial glucose increment was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Fasting C-peptide (Ratio to Baseline)

Change from baseline (week 0) in fasting C-peptide (Nanomoles per liter [nmol/L]) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Fasting Insulin (Ratio to Baseline)

Change from baseline (week 0) in fasting insulin (picomoles per liter [pmol/L]) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Fasting Pro-insulin (Ratio to Baseline)

Change from baseline (week 0) in fasting pro-insulin (pmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Fasting Glucagon (Ratio to Baseline)

Change from baseline (week 0) in fasting glucagon (picograms per milliliter [pg/mL]) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in HOMA-IR (Ratio to Baseline)

Change from baseline (week 0) in homeostatic model assessment index of insulin resistance (HOMA-IR) (%) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in HOMA-B (Ratio to Baseline)

Change from baseline (week 0) in homeostatic model assessment index of beta-cell function (HOMA-B) (%) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in C-reactive Protein (Ratio to Baseline)

Change from baseline (week 0) in C-reactive protein (milligrams per liter [mg/L]) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Body Weight (%)

Relative change from baseline (week 0) in body weight (kg) was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Body Mass Index

Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Waist Circumference

Change from baseline (week 0) in waist circumference was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Fasting Total Cholesterol (Ratio to Baseline)

Change from baseline (week 0) in fasting total cholesterol (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Fasting LDL Cholesterol (Ratio to Baseline)

Change from baseline (week 0) in fasting low density lipoprotein (LDL) cholesterol (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Fasting HDL Cholesterol (Ratio to Baseline)

Change from baseline (week 0) in fasting high density lipoprotein (HDL) cholesterol (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Fasting VLDL Cholesterol (Ratio to Baseline)

Change from baseline (week 0) in fasting very low density lipoprotein (VLDL) cholesterol (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Fasting Free Fatty Acids (Ratio to Baseline)

Change from baseline (week 0) in fasting free fatty acids (FFA) (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. Because of an issue with the handling of the blood samples for FFA, all FFA data are considered invalid for this trial; thus, no conclusion with regards to FFA levels can be made based on the FFA data. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Fasting Triglycerides (Ratio to Baseline)

Change from baseline (week 0) in fasting triglycerides (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) ADA Target (Yes/no)

Participants who achieved HbA1c <7.0% (53 mmol/mol) (American Diabetes Association (ADA) target) at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol), AACE Target (Yes/no)

Participants who achieved HbA1c ≤6.5% (48 mmol/mol) (American Association of Clinical Endocrinologists (AACE) target) at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Participants Who Achieve Weight Loss ≥5% (Yes/no)

Participants who achieved weight loss of ≥5% at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Participants Who Achieve Weight Loss ≥10% (Yes/no)

Participants who achieved weight loss of ≥10% at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)

Participants who achieved HbA1c <7.0% (53 mmol/mol) without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain at week 26 and week 52. Severe or BG-confirmed symptomatic hypoglycaemia: an episode, that is severe according to the ADA classification or BG-confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)

Participants who achieved HbA1c reduction ≥1%-point and weight loss of ≥3% at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Time to Additional Anti-diabetic Medication

Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication: use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 26/week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Time to Rescue Medication

Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication: use of new antidiabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period: the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.

Number of Treatment-emergent Adverse Events (TEAE)

A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) with onset in the on-treatment observation period (the time period where participants are considered treated with trial product) and was assessed up to approximately 57 weeks (52-week treatment period plus the 5-week follow-up period).

Change in Amylase (Ratio to Baseline)

Change from baseline (week 0) in amylase (units per liter [U/L]) at week 26 and week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Change in Lipase (Ratio to Baseline)

Change from baseline (week 0) in lipase (U/L) at week 26 and week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Change in Pulse Rate

Change from baseline (week 0) in pulse rate was evaluated at week 26 and week 52. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 26 and week 52. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Change in ECG

Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at week 26 and week 52. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS), and abnormal and clinically significant (CS)) from week 0 to week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Physical Examination

The physical examination findings (normal, abnormal NCS and abnormal CS) of the participants at week -2 and week 52 are presented for the following examinations: Cardiovascular system, Nervous system (central and peripheral); Gastrointestinal system, incl. mouth; General appearance; Head (ears, eyes, nose), throat, neck; Lymph node palpation; Musculoskeletal system; Respiratory system; Skin; Thyroid gland. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Change in Eye Examination

The eye examination findings (normal, abnormal NCS and abnormal CS) of the participants at baseline (week -2) and week 52 are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (week 0 to week 57) are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (week 0 to week 57) are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (week 0 to week 57) are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (week 0 to week 57) are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Anti-semaglutide Binding Antibody Levels

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (week 0 to week 57). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.

Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Treatment-emergent hypoglycaemia is an episode with onset in the on-treatment observation period (the time period where participants are considered treated with trial product) and was assessed up to approximately 57 weeks (52-week treatment period plus the 5-week follow-up period). Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)

Number of participants with treatment-emergent severe or BG-confirmed symptomatic hypoglycaemic episodes was recorded during week 0-57. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Semaglutide Plasma Concentrations for Population PK Analyses

Semaglutide plasma concentrations were measured after 25 minutes post-dose at week 4, 26 and 52. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

SNAC Plasma Concentrations

This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Sodium N-[8-(2-hydroxybenzoyl) amino]caprylate (SNAC) plasma concentrations were measured after 25 and 40 minutes post-dose at week 4, 26 and 52. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.

Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)

SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.

Change in CoEQ: Scores From the 4 Domains and the 19 Items

Change from baseline (week 0) in Control of Eating Questionnaire (CoEQ) was evaluated at weeks 26 and 52. The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control' (items 9-12, 19), 'positive mood' (items 5-8), 'craving for savoury' (items 4, 16-18) and 'craving for sweet' (items 3, 13-15). The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the data from the in-trial observation period.

Full Information

NCT ID

NCT02863328

First Posted

August 8, 2016

Last Updated

July 11, 2022

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT02863328

Brief Title

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

Acronym

PIONEER 2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

August 10, 2016 (Actual)

Primary Completion Date

August 1, 2017 (Actual)

Study Completion Date

March 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

822 (Actual)

8. Arms, Groups, and Interventions

Arm Title

14 mg oral semaglutide

Arm Type

Experimental

Arm Title

25 mg empagliflozin

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

semaglutide

Intervention Description

Oral administration once-daily.

Intervention Type

Drug

Intervention Name(s)

empagliflozin

Intervention Description

Oral administration once-daily.

Primary Outcome Measure Information:

Title

Change in HbA1c

Description

Time Frame

Week 0, week 26

Secondary Outcome Measure Information:

Title

Change in Body Weight (Kg)

Description

Time Frame

Week 0, week 26

Title

Change in HbA1c (%)

Description

Time Frame

Week 0, week 52

Title

Change in Body Weight (kg)

Description

Time Frame

Week 0, week 52

Title

Change in Fasting Plasma Glucose

Description

Time Frame

Week 0, week 26, week 52

Title

Change in SMPG : Mean of the 7-point Profile

Description

Time Frame

Week 0, week 26 and week 52

Title

Change in SMPG : Mean Postprandial Increment Over All Meals

Description

Time Frame

Week 0, week 26 and week 52

Title

Change in Fasting C-peptide (Ratio to Baseline)

Description

Time Frame

Week 0, week 26 and week 52

Title

Change in Fasting Insulin (Ratio to Baseline)

Description

Time Frame

Week 0, week 26 and week 52

Title

Change in Fasting Pro-insulin (Ratio to Baseline)

Description

Time Frame

Week 0, week 26 and week 52

Title

Change in Fasting Glucagon (Ratio to Baseline)

Description

Time Frame

Week 0, week 26 and week 52

Title

Change in HOMA-IR (Ratio to Baseline)

Description

Time Frame

Week 0, week 26 and week 52

Title

Change in HOMA-B (Ratio to Baseline)

Description

Time Frame

Week 0, week 26 and week 52

Title

Change in C-reactive Protein (Ratio to Baseline)

Description

Time Frame

Week 0, week 26 and week 52

Title

Change in Body Weight (%)

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Body Mass Index

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Waist Circumference

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Fasting Total Cholesterol (Ratio to Baseline)

Description

Time Frame

Week 0, week 26 and week 52

Title

Change in Fasting LDL Cholesterol (Ratio to Baseline)

Description

Time Frame

Week 0, week 26 and week 52

Title

Change in Fasting HDL Cholesterol (Ratio to Baseline)

Description

Time Frame

Week 0, week 26 and week 52

Title

Change in Fasting VLDL Cholesterol (Ratio to Baseline)

Description

Time Frame

Week 0, week 26 and week 52

Title

Change in Fasting Free Fatty Acids (Ratio to Baseline)

Description

Time Frame

Week 0, week 26 and week 52

Title

Change in Fasting Triglycerides (Ratio to Baseline)

Description

Time Frame

Week 0, week 26 and week 52

Title

Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) ADA Target (Yes/no)

Description

Time Frame

Week 26 and week 52

Title

Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol), AACE Target (Yes/no)

Description

Time Frame

Week 26 and week 52

Title

Participants Who Achieve Weight Loss ≥5% (Yes/no)

Description

Time Frame

Week 26 and week 52

Title

Participants Who Achieve Weight Loss ≥10% (Yes/no)

Description

Time Frame

Week 26 and week 52

Title

Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)

Description

Time Frame

Week 26 and week 52

Title

Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)

Description

Time Frame

Week 26 and week 52

Title

Time to Additional Anti-diabetic Medication

Description

Time Frame

Weeks 0-52

Title

Time to Rescue Medication

Description

Time Frame

Weeks 0-52

Title

Number of Treatment-emergent Adverse Events (TEAE)

Description

Time Frame

Weeks 0-57

Title

Change in Amylase (Ratio to Baseline)

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Lipase (Ratio to Baseline)

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Pulse Rate

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

Description

Time Frame

Week 0, week 26, week 52

Title

Change in ECG

Description

Time Frame

Week 0, week 26, week 52

Title

Change in Physical Examination

Description

Time Frame

Week -2, week 52

Title

Change in Eye Examination

Description

Time Frame

Week -2, week 52

Title

Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)

Description

Time Frame

Weeks 0-57

Title

Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)

Description

Time Frame

Weeks 0-57

Title

Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)

Description

Time Frame

Weeks 0-57

Title

Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)

Description

Time Frame

Weeks 0-57

Title

Anti-semaglutide Binding Antibody Levels

Description

Time Frame

Weeks 0-57

Title

Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes

Description

Time Frame

Weeks 0-57

Title

Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)

Description

Time Frame

Weeks 0-57

Title

Semaglutide Plasma Concentrations for Population PK Analyses

Description

Time Frame

Weeks 0-52

Title

SNAC Plasma Concentrations

Description

Time Frame

Weeks 0-52

Title

Description

Time Frame

Week 0, week 26, week 52

Title

Change in CoEQ: Scores From the 4 Domains and the 19 Items

Description

Time Frame

Week 0, week 26, week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Tuscumbia

State/Province

Alabama

ZIP/Postal Code

35674

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Encino

State/Province

California

ZIP/Postal Code

91436

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262-6972

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Poway

State/Province

California

ZIP/Postal Code

92064

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Spring Valley

State/Province

California

ZIP/Postal Code

91978

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34201

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32277

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32801

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Oviedo

State/Province

Florida

ZIP/Postal Code

32765

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Perry

State/Province

Georgia

ZIP/Postal Code

31069

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83646

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61603

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47713

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46254

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40502

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808-4124

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20852

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Buckley

State/Province

Michigan

ZIP/Postal Code

49620

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49009

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Butte

State/Province

Montana

ZIP/Postal Code

59701

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Albany

State/Province

New York

ZIP/Postal Code

12203

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Northport

State/Province

New York

ZIP/Postal Code

11768

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45245

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Mason

State/Province

Ohio

ZIP/Postal Code

45040-6815

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Humboldt

State/Province

Tennessee

ZIP/Postal Code

38343

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76012-4637

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Katy

State/Province

Texas

ZIP/Postal Code

77450

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78209

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78228-3419

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23219

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Caba

ZIP/Postal Code

C1417EYG

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Capital Federal

ZIP/Postal Code

1405

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Córdoba

ZIP/Postal Code

X5006IKK

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

Córdoba

ZIP/Postal Code

X5016KEH

Country

Argentina

Facility Name

Novo Nordisk Investigational Site

City

São Paulo

State/Province

Sao Paulo

ZIP/Postal Code

01228-000

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Porto Alegre

ZIP/Postal Code

90035-170

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Sao Paulo

ZIP/Postal Code

05437-010

Country

Brazil

Facility Name

Novo Nordisk Investigational Site

City

Karlovac

ZIP/Postal Code

47000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Krapinske Toplice

ZIP/Postal Code

49217

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Pula

ZIP/Postal Code

52100

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Virovitica

ZIP/Postal Code

33000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Zagreb

ZIP/Postal Code

10 000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

115 25

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-10552

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-54636

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-54642

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-54643

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-57001

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-57010

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1139

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1152

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Cegléd

ZIP/Postal Code

2700

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Nyíregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Salgótarján

ZIP/Postal Code

3100

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Szekszárd

ZIP/Postal Code

7100

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Lucca

ZIP/Postal Code

55100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Palermo

ZIP/Postal Code

90127

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Roma

ZIP/Postal Code

00133

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Bialystok

ZIP/Postal Code

15-435

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Lublin

ZIP/Postal Code

20-538

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Pulawy

ZIP/Postal Code

24-100

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Warszawa

ZIP/Postal Code

00-911

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Wroclaw

ZIP/Postal Code

50-127

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Zabrze

ZIP/Postal Code

41-800

Country

Poland

Facility Name

Novo Nordisk Investigational Site

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

117292

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

194356

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Tumen

ZIP/Postal Code

625023

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Kragujevac

ZIP/Postal Code

34000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Nis

ZIP/Postal Code

18000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Facility Name

Novo Nordisk Investigational Site

City

Almería

ZIP/Postal Code

04001

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Centelles (Barcelona)

ZIP/Postal Code

08540

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Hospitalet de Llobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

La Roca del Vallés

ZIP/Postal Code

08430

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Pozuelo de Alarcon

ZIP/Postal Code

28223

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Vic (Barcelona)

ZIP/Postal Code

08500

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Bangkoknoi, Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Novo Nordisk Investigational Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

31530666

Citation

Rodbard HW, Rosenstock J, Canani LH, Deerochanawong C, Gumprecht J, Lindberg SO, Lingvay I, Sondergaard AL, Treppendahl MB, Montanya E; PIONEER 2 Investigators. Oral Semaglutide Versus Empagliflozin in Patients With Type 2 Diabetes Uncontrolled on Metformin: The PIONEER 2 Trial. Diabetes Care. 2019 Dec;42(12):2272-2281. doi: 10.2337/dc19-0883. Epub 2019 Sep 17.

Results Reference

result

PubMed Identifier

35064550

Citation

Eliasson B, Ericsson A, Fridhammar A, Nilsson A, Persson S, Chubb B. Long-Term Cost Effectiveness of Oral Semaglutide Versus Empagliflozin and Sitagliptin for the Treatment of Type 2 Diabetes in the Swedish Setting. Pharmacoecon Open. 2022 May;6(3):343-354. doi: 10.1007/s41669-021-00317-z. Epub 2022 Jan 21.

Results Reference

result

PubMed Identifier

35373893

Citation

Aroda VR, Bauer R, Christiansen E, Haluzik M, Kallenbach K, Montanya E, Rosenstock J, Meier JJ. Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. Diabetes Obes Metab. 2022 Jul;24(7):1338-1350. doi: 10.1111/dom.14710. Epub 2022 May 9.

Results Reference

result

PubMed Identifier

36056351

Citation

Mosenzon O, Capehorn MS, De Remigis A, Rasmussen S, Weimers P, Rosenstock J. Impact of semaglutide on high-sensitivity C-reactive protein: exploratory patient-level analyses of SUSTAIN and PIONEER randomized clinical trials. Cardiovasc Diabetol. 2022 Sep 2;21(1):172. doi: 10.1186/s12933-022-01585-7.

Results Reference

derived

PubMed Identifier

32827435

Citation

Lingvay I, Capehorn MS, Catarig AM, Johansen P, Lawson J, Sandberg A, Shaw R, Paine A. Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis. J Clin Endocrinol Metab. 2020 Dec 1;105(12):e4593-604. doi: 10.1210/clinem/dgaa577.

Results Reference

derived

PubMed Identifier

32267058

Citation

Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13.

Results Reference

derived

PubMed Identifier

31903692

Citation

Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

Results Reference

derived

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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

Diabetes, Diabetes Mellitus, Type 2

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial