NCT01780272

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Jan 2013

Typical duration for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

January 17, 2013

Last Update Submit

January 20, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • The number of electroencephalogram (EEG) identified arousals

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

Secondary Outcomes (2)

  • 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

Study Arms (2)

Normoglycaemia followed by hypoglycaemia

OTHER
Other: glucose clamp

Hypoglycaemia followed by normoglycaemia

OTHER
Other: glucose clamp

Interventions

glucose clampOTHER

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 normoglycaemiaNormoglycaemia followed by hypoglycaemia

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

  • Jennum P, Stender-Petersen K, Rabol R, Jorgensen 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.

    PMID: 26407587RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Glucose Clamp Technique

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 31, 2013

Study Start

January 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations

DK(1)