Diabetes Mellitus, Type 2 MedDRA version: 18.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: Semaglutide B 1.34mg/ml PDS290
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Semaglutide
CAS Number: 910463-68-2
Other descriptive name: SEMAGLUTIDE
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. - HbA1c 7.0 – 10.5% (53 – 91 mmol/mol) (both inclusive) - Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening 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 957 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 239
Exclusion criteria
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 as required by local regulation or practice). - Any condition, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol - 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 screening. An exception is short-term insulin treatment for acute illness for a total of =14 days - History of pancreatitis (acute or chronic) - Screening calcitonin =50 ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - Renal impairment defined as eGFR < 60 mL/min/1.73 m^2 as per CKD-EPI - Subjects presently classified as being in New York Heart Association Class IV - Planned coronary, carotid or peripheral artery revascularisation on the day of screening - Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To compare the effect of once-weekly dosing of two dose levels of subcutaneous semaglutide (0.5 mg and 1.0 mg) versus once-weekly dosing of two dose levels of subcutaneous dulaglutide (0.75 mg and 1.5 mg) in subjects with type 2 diabetes on a background treatment with metformin with regards to: - Body weight control - Blood pressure - Patient reported outcomes - Safety and tolerability;Main Objective: To compare the effect of once-weekly dosing of two dose levels of subcutaneous semaglutide (0.5 mg and 1.0 mg) versus once-weekly dosing of two dose levels of subcutaneous dulaglutide (0.75 mg and 1.5 mg) on glycaemic control in subjects with type 2 diabetes on a background treatment with metformin.;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline to week 40 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in 1. Body weight (kg) 2. Fasting plasma glucose 3. Systolic and diastolic blood pressure 4. Overall scores for patient reported outcomes: Diabetes Treatment Satisfaction Questionnaire 5. Subjects who achieve (yes/no) HbA1c =6.5% (48 mmol/mol) American Association of Clinical Endocrinologists target;Timepoint(s) of evaluation of this end point: 1-4. From baseline to week 40 5. After 40 weeks treatment | — |
Countries
Canada, Croatia, European Union, Finland, Germany, Greece, Hong Kong, India, Ireland, Latvia, Lithuania, Portugal, Slovakia, Spain, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed