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

NCT01780272 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-01-23

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Denmark

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01780272 on ClinicalTrials.gov