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Insulin Degludec and Symptomatic Nocturnal Hypoglycaemia

NCT02192450 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2019-06-27

No results posted yet for this study

Summary

The purpose of this study is to determine whether insulin degludec compared to insulin glargine can reduce the risk of symptomatic nocturnal hypoglycaemia in subjects with the greatest potential benefit from optimised insulin treatment, which are patients with type 1 diabetes and high risk of nocturnal severe hypoglycaemia.

Conditions

  • Type 1 Diabetes Mellitus
  • Nocturnal Hypoglycemia
  • Recurrent Severe Hypoglycaemia

Interventions

DRUG

Insulin aspart/glargine

DRUG

Insulin aspart/degludec

Sponsors & Collaborators

  • Steno Diabetes Center Copenhagen

    collaborator OTHER

  • Hvidovre University Hospital

    collaborator OTHER

  • Copenhagen University Hospital, Denmark

    collaborator OTHER

  • Zealand University Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Esbjerg Hospital - University Hospital of Southern Denmark

    collaborator OTHER

  • Nordsjaellands Hospital

    lead OTHER

Principal Investigators

  • Ulrik Pedersen-Bjergaard, MD, DMSc · Nordsjaellands Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • Denmark

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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 NCT02192450 on ClinicalTrials.gov