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: 17.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-004994-16-AT
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-27
• Last Update Posted: 26 January 2015

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