A Trial to Investigate the Impact of Nocturnal Hypoglycaemia on Sleep in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Other: glucose clamp

Study type

Interventional

Funder types

Industry

Identifiers

NCT01780272

NN1250-3997

U1111-1127-4819 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the impact of low blood sugar during the night on sleep in subjects with type 2 diabetes.

Enrollment

26 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 2 diabetes mellitus (diagnosed clinically) for at least 24 weeks prior to screening
Currently treated with any anti-diabetic treatment (incl. diet and exercise) except insulin with a stable dose for more than 4 weeks prior to screening
Body mass index below 35 kg/m^2

Exclusion criteria

Severe hypoglycaemic event during the past 6 months or hospitalisation for diabetic ketoacidosis during the previous 6 months
Any other chronic disorder or severe disease by clinical information (including chronic obstructive pulmonary disease (COPD), sleep apnoea and epilepsy) which, in the opinion of the investigator might jeopardise subject's sleep, safety or compliance with the protocol, or subjects with mental incapacity or language barriers precluding adequate understanding or co-operation or who, in the opinion of the investigator, should not participate in the trial
Use of antidepressants, antipsychotics, hypnotics, sedatives or other drugs known to influence sleep within 12 weeks prior to screening