Effect of Liraglutide on the Beta-cell Responsiveness in Subjects With Type 2 Diabetes Compared to a Healthy Control Group

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: liraglutide

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01511185

NN2211-2063

Details and patient eligibility

About

This trial is conducted in the United States of America (USA). The aim of this trial is to assess the effect of NNC 90-1170 on beta-cell responsiveness to increasing blood glucose concentrations in subjects with type 2 diabetes.

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed with type 2 diabetes, either newly diagnosed with at least 2 months of diet or on OAD monotherapy for at least 3 months
Body Mass Index (BMI): 24-35 kg/m^2 inclusive

Exclusion criteria

SUBJECTS WITH TYPE 2 DIABETES
Receipt of any investigational drug within three months prior to this trial
Recurrent severe hypoglycemia as judged by the investigator
Cardiac disease
Use of any drug (except an OAD (oral anti-diabetic drug)) that in the investigator's opinion could interfere with the blood glucose level
Haemoglobin maximum 10 g/L
HbA1c above 12%
Loss of more than 400 mL blood during the 3 months prior to trial start
HEALTHY SUBJECTS
Receipt of any investigational drug within 3 months prior to this trial
Clinically relevant cardiac disease or any clinically significant abnormal ECG (electrocardiogram)
Use of any drug that in the investigator's opinion could interfere with the blood glucose level
Haemoglobin max. 10 g/L
HbA1c at least 6%