NCT02192450

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_4

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

First Submitted

Initial submission to the registry

July 9, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

4.2 years

First QC Date

July 9, 2014

Last Update Submit

June 26, 2019

Conditions

Type 1 Diabetes MellitusNocturnal HypoglycemiaRecurrent Severe Hypoglycaemia

Keywords

Diabetes MellitusHypoglycaemiaGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesInsulinHypoglycaemic AgentsPhysiological Effetcs of Drugs

Outcome Measures

Primary Outcomes (1)

  • Symptomatic nocturnal hypoglycaemia

    9 months (3-12) of each treatment period

Secondary Outcomes (9)

  • Severe hypoglycaemia (total, night-time, daytime)

    9 months (3-12) of each treatment period

  • Any nocturnal hypoglycaemia (incl. asymptomatic/silent events)

    9 months (3-12) of each treatment period

  • Any daytime hypoglycaemia (symptomatic, asymptomatic/silent and severe)

    9 months (3-12) of each treatment period

  • Any CGM recorded hypoglycaemia (symptomatic, asymptomatic/silent and severe)

    2 x 6 days in each treatment arm

  • Any in-hospital nocturnal hypoglycaemia (incl. asymptomatic/silent events)

    2 overnight stays in each treatment arm

  • +4 more secondary outcomes

Study Arms (2)

Insulin glargine

ACTIVE COMPARATOR

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

Insulin degludec

EXPERIMENTAL

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

Interventions

Insulin aspart/glargineDRUG
Also known as: NovoRapid, Lantus
Insulin glargine
Insulin aspart/degludecDRUG
Also known as: NovoRapid, Tresiba
Insulin degludec

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordsjaellands Hospital

Hilleroed, 3400, Denmark

Location

Related Publications (2)

  • Brosen JMB, Agesen RM, Alibegovic AC, Ullits Andersen H, Beck-Nielsen H, Gustenhoff P, Krarup Hansen T, Hedetoft CGR, Jensen TJ, Stolberg CR, Bogh Juhl C, Lerche SS, Norgaard K, Parving HH, Tarnow L, Thorsteinsson B, Pedersen-Bjergaard U. Continuous Glucose Monitoring-Recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia. Diabetes Technol Ther. 2022 Sep;24(9):643-654. doi: 10.1089/dia.2021.0567. Epub 2022 Jun 22.

    PMID: 35467938DERIVED

  • Agesen RM, Alibegovic AC, Andersen HU, Beck-Nielsen H, Gustenhoff P, Hansen TK, Hedetoft C, Jensen T, Juhl CB, Lerche SS, Norgaard K, Parving HH, Tarnow L, Thorsteinsson B, Pedersen-Bjergaard U. The effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in adults with type 1 diabetes and high risk of nocturnal severe hypoglycaemia (the HypoDeg trial): study rationale and design. BMC Endocr Disord. 2019 Jul 23;19(1):78. doi: 10.1186/s12902-019-0408-x.

    PMID: 31337371DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1HypoglycemiaDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesInsulin Resistance

Interventions

Insulin AspartInsulin Glargineinsulin degludec, insulin aspart drug combinationinsulin degludec

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesImmune System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Long-Acting

Study Officials

  • Ulrik Pedersen-Bjergaard, MD, DMSc

    Nordsjaellands Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 16, 2014

Study Start

January 1, 2015

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

June 27, 2019

Record last verified: 2019-06

Locations

DK(1)