Insulin Degludec and Symptomatic Nocturnal Hypoglycaemia (HypoDeg)

June 26, 2019 updated by: Nordsjaellands Hospital

The Effect of Insulin Degludec on Risk of Symptomatic Nocturnal Hypoglycaemia in Subjects With Type 1 Diabetes and High Risk of Nocturnal Severe Hypoglycaemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Insulin degludec is a novel insulin analogue that may reduce the risk of mild nocturnal hypoglycaemia in type 1 diabetes. Patients with type 1 diabetes and recurrent severe hypoglycaemia (high risk patients) are also burdened by nocturnal hyoglycaemia (mild and silent). These episodes may contribute to the developement of hormonal counterregulatory failure and hypoglycaemia unawareness, which in turn increases the risk of further hypoglycaemic episodes, especially epiosdes of severe hypoglycaemia.The effect of insulin degludec on risk of mild nocturnal hypoglycaemia in subjects with type 1 diabetes and high risk of severe hypoglycaemia compared to insulin glargine is to be investigated.

Study design and intervention: A controlled, cross-over multi-centre study in a Prospective, Randomised, Open, Blinded Endpoint (PROBE) design. Each treatment period last for 12 months. Patients will be randomised to treatment with basal-bolus therapy with insulin aspart/degludec or insulin aspart/glargine in random order. Endpoints will be assessed during the last 9 months of each treatment arm.

Subjects: 175 type 1 diabetic patients with a history of one or more episodes of nocturnal severe hypoglycaemia during the proceeding two years.

Method: Patients will record all events of symptomatic (mild), asymptomatic (silent) and severe hypoglycaemia in a diary. All events of symptomatic nocturnal and severe hypoglycaemia must also be reported by telephone within 24 hours. Patients will be instructed to do and record self-monitored blood glucose (SMBG) i.e. 4-point profiles twice per week (blood glucose before breakfast, before lunch, before dinner and before bedtime).

Outcomes: See "Outcome Measures". Concerning the primary endpoint all possible symptomatic nocturnal hypoglycaemic episodes will be adjudicated by an independent endpoint committee consisting of diabetes specialists blinded to the individual patient insulin regimen.

Safety: Adverse reactions

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hilleroed, Denmark, 3400
        • Nordsjaellands Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 diabetes > 5 years
  • One or more episodes of nocturnal severe hypoglycaemia during the preceding two years
  • Treated with multiple dose insulin injection (>2) or insulin pump. Both human insulin and insulin analogues are allowed
  • Willingness to a once daily (OD) regimen concerning insulin degludec and insulin glargine
  • Willingness to do self-monitoring of blood glucose (SMBG) and keep a diary
  • Signed informed consent

Exclusion Criteria:

  • History of primary and secondary adrenal insufficiency, growth hormone deficiency, or untreated myxoedema
  • History of unstable angina or major cardiovascular events (myocardial infarction, coronary re-vascularisation, transient ischaemic attack, or stroke within the last three months)
  • Heart failure, New York Heart Association (NYHA) class IV
  • History of malignancy unless a disease-free period exceeding five years
  • History of alcohol or drug abuse
  • Treatment with glucose lowering agent(s) other than insulin
  • Pregnant or lactating women
  • Women of childbearing potential who are not using chemical (P-pills or gestagen depots) or mechanical (intra-uterine device) contraception
  • Participation in another investigational drug study within the last 3 months
  • Inability to understand the informed consent
  • HbA1c > 86 mmol/mol (10%)
  • Shifting working hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Insulin glargine

Each treatment arm last for 12 months - 3 months of run-in/cross-over and 9 months of maintenance.

Patients will be randomised (1:1) to treatment with basal-bolus therapy with insulin aspart/degludec or insulin aspart/glargine in random order.

After 12 months of treatment patients will cross-over to the other basal-bolus therapy.

Insulin degludec and insulin glargine is administered once daily at the evening meal and insulin aspart is administered three times daily before the main meals.
Drug: Insulin aspart/glargine
Other Names:
  • Lantus
  • NovoRapid
EXPERIMENTAL: Insulin degludec

Each treatment arm last for 12 months - 3 months of run-in/cross-over and 9 months of maintenance.

Patients will be randomised (1:1) to treatment with basal-bolus therapy with insulin aspart/degludec or insulin aspart/glargine in random order.

After 12 months of treatment patients will cross-over to the other basal-bolus therapy.

Insulin degludec and insulin glargine is administered once daily at the evening meal and insulin aspart is administered three times daily before the main meals.
Drug: Insulin aspart/degludec
Other Names:
  • Tresiba
  • NovoRapid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptomatic nocturnal hypoglycaemia
Time Frame: 9 months (3-12) of each treatment period
9 months (3-12) of each treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Severe hypoglycaemia (total, night-time, daytime)
Time Frame: 9 months (3-12) of each treatment period
9 months (3-12) of each treatment period
Any nocturnal hypoglycaemia (incl. asymptomatic/silent events)
Time Frame: 9 months (3-12) of each treatment period
9 months (3-12) of each treatment period
Any daytime hypoglycaemia (symptomatic, asymptomatic/silent and severe)
Time Frame: 9 months (3-12) of each treatment period
9 months (3-12) of each treatment period
Any CGM recorded hypoglycaemia (symptomatic, asymptomatic/silent and severe)
Time Frame: 2 x 6 days in each treatment arm
2 x 6 days in each treatment arm
Any in-hospital nocturnal hypoglycaemia (incl. asymptomatic/silent events)
Time Frame: 2 overnight stays in each treatment arm
2 overnight stays in each treatment arm
Change in HbA1c
Time Frame: From baseline to after 12 months of treatment
From baseline to after 12 months of treatment
Change in glycaemic variability
Time Frame: 4 x overnight stays and 4 x 6 days of CGM
4 x overnight stays and 4 x 6 days of CGM
Insulin doses
Time Frame: End of each treatment period
End of each treatment period
Quality of life incl. pre-depression scale
Time Frame: At baseline, cross-over and after 24 months
At baseline, cross-over and after 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordsjaellands Hospital

Collaborators

Odense University Hospital
Zealand University Hospital
Aarhus University Hospital
Hvidovre University Hospital
Steno Diabetes Center Copenhagen
Copenhagen University Hospital, Denmark
Hospital of South West Jutland

Investigators

  • Principal Investigator: Ulrik Pedersen-Bjergaard, MD, DMSc, Nordsjaellands Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

February 28, 2019

Study Completion (ACTUAL)

February 28, 2019

Study Registration Dates

First Submitted

July 9, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (ESTIMATE)

July 16, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 26, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HypoDeg

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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