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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Other: glucose clamp

• Registration Number: NCT01780272
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-31
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hypoglycaemia followed by normoglycaemia	glucose clamp	-
Normoglycaemia followed by hypoglycaemia	glucose clamp	-

Primary Outcome Measures

Name	Time	Method
The number of electroencephalogram (EEG) identified arousals	During the first four hours (0-4 hours) after reaching sleep stage N2

Secondary Outcome Measures

Name	Time	Method
Total sleep time	0-8 hours
Time spent in the different sleep stages (% of total sleep time): Sleep stage N1, Sleep stage N2, Sleep stage N3 and Rapid Eye Movement (REM) sleep	During the first four hours (0-4 hours) after reaching sleep stage N2

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇰 Glostrup, Denmark