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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01780272
First received: January 17, 2013
Last updated: October 8, 2013
Last verified: October 2013

January 17, 2013
October 8, 2013
January 2013
September 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01780272 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Trial to Investigate the Impact of Nocturnal Hypoglycaemia on Sleep in Subjects With Type 2 Diabetes
A Trial to Investigate the Impact of Nocturnal Hypoglycaemia on Sleep in Subjects With Type 2 Diabetes

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
  • Diabetes
  • Diabetes Mellitus, Type 2
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.
  • Normoglycaemia followed by hypoglycaemia
    Intervention: Other: glucose clamp
  • Hypoglycaemia followed by normoglycaemia
    Intervention: Other: glucose clamp
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01780272
NN1250-3997, U1111-1127-4819
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP