Diabetes Mellitus, Type 2 MedDRA version: 17.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: Semaglutide 2.5 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: SEMAGLUTIDE
CAS Number: 910463-68-2
Current Sponsor code: NNC0113-0217
Other descriptive name: SEMAGLUTIDE
Concentrati
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, age = 18 years at the time of signing inform consent - BMI =25 and =40 kg/m^2 - Subjects diagnosed with T2D treated with diet and exercise and/or who have been on a stable dose of metformin for at least 30 days prior to screening - HbA1c 7.0-9.5% (53-80 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 482 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 121
Exclusion criteria
Exclusion criteria: - Subjects on selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants - History of chronic pancreatitis or idiopathic acute pancreatitis - Chronic malabsorption, regardless of aetiology - History of Crohn’s disease, ulcerative colitis, or other inflammatory bowel disease - Treatment with glucose lowering agent(s) other than metformin as stated in the inclusion criteria in a period of 90 days before the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy on glycaemic control of oral semaglutide in a SNAC formulation against placebo in subjects with T2D;Secondary Objective: - To compare the efficacy on glycaemic control of oral semaglutide in a SNAC formulation against s.c. semaglutide in subjects with T2D - To compare the safety and tolerability of three dose escalation schemes using a single end dose level during 26 weeks administration of oral semaglutide and SNAC in a tablet formulation in subjects with T2D;Primary end point(s): Change in HbA1c ;Timepoint(s) of evaluation of this end point: From baseline to after 26 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Subjects who achieve (yes/no) HbA1c <7% (53 mmol/mol) 2. Change in body weight 3. Change in waist circumference 4. Change in body mass index (BMI) 5. Number of treatment emergent adverse events (TEAEs) 6. Number of confirmed hypoglycaemic episodes ;Timepoint(s) of evaluation of this end point: 1. After 26 weeks of treatment 2. - 4. From baseline to after 26 weeks of treatment 5. - 6. recorded from baseline until week 31 | — |
Countries
Austria, Bulgaria, Canada, Denmark, European Union, Germany, Israel, Italy, Malaysia, Serbia, South Africa, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed