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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01780272
First Posted: January 31, 2013
Last Update Posted: January 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
January 17, 2013
January 31, 2013
January 23, 2017
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 ]
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 ]
  • Total sleep time [ Time Frame: 0-8 hours ]
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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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
Jennum P, Stender-Petersen K, Rabøl R, Jørgensen NR, Chu PL, Madsbad S. The Impact of Nocturnal Hypoglycemia on Sleep in Subjects With Type 2 Diabetes. Diabetes Care. 2015 Nov;38(11):2151-7. doi: 10.2337/dc15-0907. Epub 2015 Sep 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
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
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01780272
NN1250-3997
U1111-1127-4819 ( Other Identifier: WHO )
No
Not Provided
Not Provided
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
January 2017

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