A Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counterregulation Compared to Placebo in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: placebo

Drug: semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02147431

U1111-1144-7019 (Other Identifier)

2013-002751-15 (EudraCT Number)

NN9535-3684

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the effect of semaglutide on hypoglycaemic counter-regulation compared to placebo in subjects with type 2 diabetes.

Enrollment

38 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects diagnosed with type 2 diabetes and on stable treatment for a period of 90 days prior to screening with metformin as monotherapy. Stable is defined as unchanged dose
Male or female, age between18-64 years (both inclusive) at the time of signing informed consent
Body Mass Index (BMI) between 20.0-35.0 kg/m^2 (both inclusive)
HbA1c (glycosylated haemoglobin) between 6.5-10.0% (both inclusive)

Exclusion criteria

Treatment with any glucose lowering agent(s) other than metformin in a period of 90 days before screening. An exception is short-term treatment (less than or equal to 7 days in total) with insulin in connection with intercurrent illness
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Blood or plasma donation within the past month or more than 500 mL within the last 3 months prior to first semaglutide dosing