Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; liraglutide; placebo
Intervention description: Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.; Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.; Administered subcutaneously ( s.c., under the skin) once daily.
Intervention MeSH terms: Liraglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 706.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of this trial is to investigate dose-finding of
      semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects
      with type 2 diabetes
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age at least 18 years at the time of signing informed consent.

          -  Subjects should be on stable diabetes treatment consisting of diet and exercise with
             or without metformin (at least 1500 mg daily or maximum tolerated dose documented in
             the patient medical record) for at least 90 days prior to screening

          -  HbA1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive)

          -  BMI: 25.0 - 40.0 kg/m^2 (both inclusive)

        Exclusion Criteria:

          -  Simultaneous participation in any other clinical trial of an investigational medicinal
             product

          -  Female who is pregnant, breast-feeding or intends to become pregnant or is of
             child-bearing potential and not using adequate contraceptive methods throughout the
             trial including the 7 weeks follow-up period (adequate contraceptive measures as
             required by local regulation or practice). Germany: Only highly effective methods of
             birth control are accepted (i.e. one that results in less than 1% per year failure
             rate when used consistently and correctly such as implants, injectables, combined oral
             contraceptives, some intrauterine device), or sexual abstinence or vasectomised
             partner. United Kingdom: Adequate contraceptive measures are defined as established
             use of oral, injected or implanted hormonal methods of contraception, placement of an
             intrauterine device or intrauterine system, barrier methods of contraception (condom
             or occlusive cap with spermicidal foam/gel/film/cream/suppository), female
             sterilisation, male sterilisation (where partner is sole partner of subject), or true
             abstinence (when in line with preferred and usual lifestyle)

          -  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 illnesses for a total of below or equal to
             14 days)

          -  Anticipated initiation or change in concomitant medications (for more than 14
             consecutive days or on an frequent basis) known to affect weight or glucose metabolism
             (e.g. orlistat, thyroid hormones, corticosteroids)

          -  History of pancreatitis (acute or chronic)

          -  Screening calcitonin above or equal to 50 ng/L

          -  Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary
             Thyroid Carcinoma (MTC)

          -  Severe to moderate renal impairment defined as GFR, estimated below 60 ml/min/1.73 m^2
             as per CKD-EPI (Chronic Kidney Disease Epidemiology)

          -  Within the past 180 days before screening any of the following: Myocardial infarction,
             stroke or hospitalisation for unstable angina and/or transient ischemic attack

          -  Currently planned coronary, carotid or peripheral artery revascularisation

          -  Patients presently classified as being in New York Heart Association (NYHA) Class III
             or IV