Overview

Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes

Status:
Completed
Trial end date:
2014-12-11
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted globally. The aim of the trial is to examine the dose range, escalation and efficacy of oral semaglutide in subjects with type 2 diabetes.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Criteria
Inclusion Criteria:

- BMI above or equal to 25 and below or equal to 40 kg/m^2

- Subjects diagnosed with T2D (Type 2 diabetes) 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)

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