Multiple dose trial examining dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2
MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2012-004994-16-ES

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 603

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

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- 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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Subjects who achieve (yes/no) HbA1c <7% (53 mmol/mol)<br>2. Change in body weight <br>3. Change in waist circumference <br>4. Change in body mass index (BMI) <br>5. Number of treatment emergent adverse events (TEAEs) <br>6. Number of confirmed hypoglycaemic episodes;Timepoint(s) of evaluation of this end point: 1. After 26 weeks of treatment<br>2. - 4. From baseline to after 26 weeks of treatment<br>5. - 6. recorded from baseline until week 31