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Clinical Trials/NCT03018028
NCT03018028
Completed
Phase 3

Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes

Novo Nordisk A/S1 site in 1 country243 target enrollmentStarted: January 10, 2017Last updated:
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ConditionsDiabetesDiabetes Mellitus, Type 2
InterventionsSemaglutidePlaceboLiraglutide
DrugsSemaglutidePlaceboLiraglutide

Overview

Phase
Phase 3
Status
Completed
Enrollment
243
Locations
1
Primary Endpoint
Change in HbA1c (Week 26)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This trial is conducted in Asia. The aim of this trial is to investigate the dose-response relationship of once-daily dosing of three dose levels (3, 7 and 14 mg) of oral semaglutide versus placebo as monotherapy on glycaemic control in Japanese subjects with type 2 diabetes mellitus

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •Japanese male or female, age above or equal to 20 years at the time of signing informed consent
  • •Diagnosed with type 2 diabetes mellitus for at least 30 days prior to day of screening
  • •HbA1c 6.5%-9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oral antidiabetic drug as monotherapy and 7.0%-10.0% (53-86 mmol/mol) (both inclusive) for subjects treated with diet and exercise therapy alone
  • •Treatment for at least 30 days prior to day of screening with;- stable daily dose of oral anti-diabetic drug as monotherapy (allowed oral anti-diabetic drugs are: metformin, sulphonylurea, glinide, α-glucosidase inhibitor, dipeptidyl peptidase-4 inhibitor and sodium-glucose cotransporter-2 inhibitor) at a half-maximum approved dose or below according to Japanese labelling in addition to diet and exercise therapy. or - diet and exercise therapy alone

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 measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives
  • •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 (MEN 2) or medullary thyroid carcinoma (MTC)
  • •History of pancreatitis (acute or chronic)
  • •History of major surgical procedures involving the stomach and 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
  • •Subject 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
  • •Subjects with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL)
  • •Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 30 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)

Arms & Interventions

Oral semaglutide 3 mg

Experimental

Intervention: Semaglutide (Drug)

Oral semaglutide 7 mg

Experimental

Intervention: Semaglutide (Drug)

Oral semaglutide 14 mg

Experimental

Intervention: Semaglutide (Drug)

Oral placebo

Placebo Comparator

Intervention: Placebo (Drug)

Liraglutide 0.9 mg

Active Comparator

Intervention: Liraglutide (Drug)

Outcomes

Primary Outcomes

Change in HbA1c (Week 26)

Time Frame: Week 0, week 26

Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c). The endpoint was analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. The endpoint was also evaluated based on data from the in-trial observation period. In-trial observation period - 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.

Secondary Outcomes

  • Change in HbA1c (Week 52)(Week 0, week 52)
  • Change in Fasting Plasma Glucose(Week 0, week 26, week 52)
  • Change in VLDL Cholesterol (Ratio to Baseline)(Week 0, week 26 and week 52)
  • Change in Fasting Insulin (Ratio to Baseline)(Week 0, week 26 and week 52)
  • Change in Fasting C-peptide (Ratio to Baseline)(Week 0, week 26 and week 52)
  • Change in Fasting Pro-insulin (Ratio to Baseline)(Week 0, week 26 and week 52)
  • Change in Body Weight (kg)(Week 0, week 26, week 52)
  • Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile(Week 0, week 26, week 52)
  • Change in Body Weight (%)(Week 0, week 26 and week 52)
  • Change in Waist Circumference(Week 0, week 26 and week 52)
  • Change in Fasting Glucagon (Ratio to Baseline)(Week 0, week 26 and week 52)
  • Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline)(Week 0, week 26 and week 52)
  • Change in Beta-cell Function (HOMA-B) (Ratio to Baseline)(Week 0, week 26 and week 52)
  • Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No)(Week 26 and week 52)
  • Change in Mean Postprandial Increment Over All Meals in SMPG(Week 0, week 26 and week 52)
  • Change in Body Mass Index(Week 0, week 26 and week 52)
  • Change in Total Cholesterol (Ratio to Baseline)(Week 0, week 26 and week 52)
  • Change in HDL Cholesterol (Ratio to Baseline)(Week 0, week 26 and week 52)
  • Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline)(Week 0, week 26 and week 52)
  • Change in LDL Cholesterol (Ratio to Baseline)(Week 0, week 26 and week 52)
  • Change in Triglycerides (Ratio to Baseline)(Week 0, week 26 and week 52)
  • Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no)(Week 26 and week 52)
  • Change in Physical Examination(Baseline (Week -8), week 26, week 52)
  • Anti-semaglutide Neutralising Antibodies (Yes/no)(Week 0 - 57)
  • Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No)(Week 26 and week 52)
  • Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)(Week 26 and week 52)
  • Time to Rescue Medication(Weeks 0 - 52)
  • Anti-semaglutide Binding Antibodies (Yes/no)(Week 0 - 57)
  • Anti-semaglutide Binding Antibody Levels(Weeks 0-57)
  • Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3%(Week 26 and week 52)
  • Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No)(Week 26 and week 52)
  • Change in Amylase (Ratio to Baseine)(Week 0, week 26, week 52)
  • Change in Lipase (Ratio to Baseine)(Week 0, week 26, week 52)
  • Change in Pulse Rate(Week 0, week 26, week 52)
  • Change in ECG Evaluation(Week 0, week 26, week 52)
  • Time to Additional Anti-diabetic Medication(Weeks 0 - 52)
  • Number of Treatment-emergent Adverse Events (TEAEs)(Weeks 0 - 57)
  • Change in Blood Pressure(Week 0, week 26, week 52)
  • Change in Eye Examination Category(Week -8, Week 52)
  • Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)(Week 0 - 57)
  • Change From Baseline in DTR-QOL: Total Score(Week 0, week 26, week 52)
  • Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)(Week 0 - 57)
  • Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes(Week 0 - 57)
  • Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0 - 57)
  • Semaglutide Plasma Concentration(Week 26 and week 52)
  • Change in SF-36: Sub-domains(Week 0, week 26, week 52)
  • Change From Baseline in DTR-QOL: Sub-domains(Week 0, week 26, week 52)
  • Change in SF-36: Physical Component Summary (PCS)(Week 0, week 26, week 52)
  • Change in SF-36: Mental Component Summary (MCS)(Week 0, week 26, week 52)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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