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

Purpose

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.

Condition	Intervention	Phase
Diabetes Diabetes Mellitus, Type 2	Other: glucose clamp	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic
Official Title:	A Trial to Investigate the Impact of Nocturnal Hypoglycaemia on Sleep in Subjects With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Hypoglycemia

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

The number of electroencephalogram (EEG) identified arousals [ Time Frame: During the first four hours (0-4 hours) after reaching sleep stage N2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: During the first four hours (0-4 hours) after reaching sleep stage N2 ] [ Designated as safety issue: No ]
Total sleep time [ Time Frame: 0-8 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	January 2013
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Normoglycaemia followed by hypoglycaemia	Other: glucose clamp 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.
Hypoglycaemia followed by normoglycaemia	Other: glucose clamp 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.

Arms

Assigned Interventions

Normoglycaemia followed by hypoglycaemia

Other: glucose clamp

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.

Hypoglycaemia followed by normoglycaemia

Other: glucose clamp

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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780272

Contacts

Contact: Novo Nordisk

clinicaltrials@novonordisk.com

Locations

Denmark
	Recruiting
Glostrup, Denmark, 2600

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Kirstine Lynge Stender-Petersen

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT01780272 History of Changes
Other Study ID Numbers:	NN1250-3997, U1111-1127-4819
Study First Received:	January 17, 2013
Last Updated:	January 31, 2013
Health Authority:	Denmark: Danish Medicines Agency

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia

Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013