Diabetes Mellitus, Type 2 MedDRA version: 18.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: Semaglutide B 1.34 mg/ml PDS290
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: SEMAGLUTIDE
CAS Number: 910463682
Current Sponsor code: NNC0113-0217
Co
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, age = 18 years at the time of signing informed consent. For Japan only: Age = 20 years - Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 90 days prior to screening with either metformin = 1500 mg (or maximum tolerated dose), pioglitazone = 30 mg (or maximum tolerated dose), rosiglitazone = 4 mg (or maximum tolerated dose) or a combination of either metformin/pioglitazone or metformin/rosiglitazone (doses as for individual therapies). Stable is defined as unchanged medication and unchanged dose. - HbA1c 7.0 – 10.5 % (53 – 91 mmol/mol) (both inclusive) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 960 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local law or practice) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject’s safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (= 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value = 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as eGFR < 60 ml/min/1.73 m2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) class IV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of once-weekly dosing of two dose levels of semaglutide versus sitagliptin 100 mg once-daily on glycaemic control after 56 weeks of treatment;Secondary Objective: To compare the effect of once-weekly dosing of two dose levels of semaglutide versus sitagliptin 100 mg once-daily after 56 weeks of treatment on: - Inducing and maintaining weight loss - Other parameters of efficacy, safety and tolerability;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline to week 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Confirmatory efficacy endpoint: 1. Change in body weight Supportive efficacy endpoints: Change in: 2. Fasting Plasma Glucose (FPG) 3. Systolic and diastolic blood pressure 4. Patient reported outcome (PRO) questionnaire Diabetes Treatment Satisfaction Questionnaire status (DTSQs) These endpoints will be evaluated as the mean treatment differences. Subjects who achieve (yes/no): 5. HbA1c =6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target This endpoint will be evaluated as the odds ratio between treatments.;Timepoint(s) of evaluation of this end point: Confirmatory efficacy endpoint: 1. From baseline to week 56 Supportive efficacy endpoints: 2.-4. From baseline to week 56 5. After 56 weeks treatment | — |
Countries
Argentina, Bulgaria, Czech Republic, European Union, Hong Kong, Hungary, India, Japan, Mexico, Norway, Portugal, Russian Federation, South Africa, Spain, Sweden, Thailand, Turkey, Ukraine
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed