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Insulin Degludec and Symptomatic Nocturnal Hypoglycaemia (HypoDeg)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02192450
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : June 27, 2019
Sponsor:
Collaborators:
Steno Diabetes Center Copenhagen
Hvidovre University Hospital
Copenhagen University Hospital, Denmark
Zealand University Hospital
Odense University Hospital
Aarhus University Hospital
Sydvestjysk Hospital
Information provided by (Responsible Party):
Nordsjaellands Hospital

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Nocturnal Hypoglycemia Recurrent Severe Hypoglycaemia Drug: Insulin aspart/glargine Drug: Insulin aspart/degludec Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Insulin Degludec on Risk of Symptomatic Nocturnal Hypoglycaemia in Subjects With Type 1 Diabetes and High Risk of Nocturnal Severe Hypoglycaemia
Study Start Date : January 2015
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019


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:
  • NovoRapid
  • Lantus

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:
  • NovoRapid
  • Tresiba




Primary Outcome Measures :
  1. Symptomatic nocturnal hypoglycaemia [ Time Frame: 9 months (3-12) of each treatment period ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192450


Locations
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Denmark
Nordsjaellands Hospital
Hilleroed, Denmark, 3400
Sponsors and Collaborators
Nordsjaellands Hospital
Steno Diabetes Center Copenhagen
Hvidovre University Hospital
Copenhagen University Hospital, Denmark
Zealand University Hospital
Odense University Hospital
Aarhus University Hospital
Sydvestjysk Hospital
Investigators
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Principal Investigator: Ulrik Pedersen-Bjergaard, MD, DMSc Nordsjaellands Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT02192450    
Other Study ID Numbers: HypoDeg
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Keywords provided by Nordsjaellands Hospital:
Diabetes Mellitus
Hypoglycaemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Insulin
Hypoglycaemic Agents
Physiological Effetcs of Drugs
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs