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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: glucose clamp


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Normoglycaemia followed by hypoglycaemia<br> | Other: glucose clamp<br>* Each subject will complete one adaptation night visit followed by two experimental night visits, one normoglycaemic and one hypoglycaemic, in randomised order. While subjects are asleep, sleep patterns will be monitored online using polysomnographic recordings during a hypoglycaemic and a normoglycaemic clamp (using constant intravenous (i.v.) infusion of human soluble insulin (Actrapid®)). Plasma glucose will be monitored.<br>|
| Other: Hypoglycaemia followed by normoglycaemia<br> | Other: glucose clamp<br>* Each subject will complete one adaptation night visit followed by two experimental night visits, one normoglycaemic and one hypoglycaemic, in randomised order. While subjects are asleep, sleep patterns will be monitored online using polysomnographic recordings during a hypoglycaemic and a normoglycaemic clamp (using constant intravenous (i.v.) infusion of human soluble insulin (Actrapid®)). Plasma glucose will be monitored.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of electroencephalogram (EEG) identified arousals |  | During the first four hours (0-4 hours) after reaching sleep stage N2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Total sleep time |  | 0-8 hours |