Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01780272
NCT01780272CompletedPhase 1

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

Novo Nordisk A/S2 sites in 1 country26 target enrollmentStarted: January 2013Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
26
Locations
2
Primary Endpoint
The number of electroencephalogram (EEG) identified arousals
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Diagnostic
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

The number of electroencephalogram (EEG) identified arousals

Time Frame: During the first four hours (0-4 hours) after reaching sleep stage N2

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials

Withdrawn
Not Applicable
Chronotherapy in Children With Chronic Kidney DiseaseChronic Kidney DiseasesHypertension
NCT05353335Yale University26
Not yet recruiting
Not Applicable
The Role of Timed Awakening in Treatment of EnuresisNocturnal EnuresisVoiding Dysfunction
NCT06586476Children's Hospital Los Angeles40
Completed
Phase 1
A Trial to Assess the Effect of Liraglutide on Gastric Emptying in Healthy Obese VolunteersMetabolism and Nutrition DisorderObesity
NCT00978393Novo Nordisk A/S49
Completed
Phase 1
Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 DiabeticsDiabetesDiabetes Mellitus, Type 1
NCT01002768Novo Nordisk A/S28
Completed
Phase 1
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.Growth Hormone DisorderAdult Growth Hormone DeficiencyGrowth Hormone Deficiency in Children
NCT03212131Novo Nordisk A/S34
A Trial to Investigate the Impact of... | Clinical Trial