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A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (SWITCH 1)

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ClinicalTrials.gov Identifier: NCT02034513
Recruitment Status : Completed
First Posted : January 13, 2014
Results First Posted : May 15, 2017
Last Update Posted : January 2, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar), both with insulin aspart (IAsp) as mealtime insulin in subjects with type 1 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin degludec Drug: insulin glargine Drug: insulin aspart Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 501 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Cross-over Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (SWITCH 1)
Actual Study Start Date : January 5, 2014
Actual Primary Completion Date : January 11, 2016
Actual Study Completion Date : January 11, 2016


Arm Intervention/treatment
Experimental: IDeg OD + IAsp followed by IGlar OD + IAsp
Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period
Drug: insulin degludec
Administered once daily, injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

Drug: insulin glargine
Administered once daily, injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

Drug: insulin aspart
Administered 2-4 times daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

Active Comparator: IGlar OD + IAsp followed by IDeg OD + IAsp
Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period
Drug: insulin degludec
Administered once daily, injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

Drug: insulin glargine
Administered once daily, injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

Drug: insulin aspart
Administered 2-4 times daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.




Primary Outcome Measures :
  1. Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period [ Time Frame: A 16-week treatment period. ]
    Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Maintenance period: 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64).


Secondary Outcome Measures :
  1. Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes During the Maintenance Period [ Time Frame: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64) ]
    Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.

  2. Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period [ Time Frame: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64) ]
    Percentage of subjects who experienced one or more severe hypoglycaemic episodes during the maintenance period. Severe hypoglycaemia (according to the American Diabetes Association 2013 definition): A hypoglycaemic episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose values may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.

  3. Incidence of Treatment Emergent Adverse Events [ Time Frame: During 32 weeks of treatment for each treatment period ]
    Treatment emergent adverse event was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.

  4. Change From Baseline in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 32, Week 64 ]
    Change from baseline in HbA1c (glycosylated haemoglobin) at week 32 (treatment period 1) and at week 64 (treatment period 2). Week 32 HbA1c absolute value was considered as baseline for calculating change from baseline in HbA1c at week 64.

  5. FPG (Fasting Plasma Glucose) [ Time Frame: Week 32 and Week 64 ]
    Fasting plasma glucose values at week 32 and week 64.



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: - Subjects fulfilling at least one of the below criteria: a) Experienced at least one severe hypo episode within the last year (according to the ADA (American Diabetes Association) definition, April 2013) b) Moderate chronic renal failure, defined as glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-Epi (chronic kidney disease epidemiology collaboration) c) Hypoglycaemic symptom unawareness d) Diabetes mellitus duration for more than 15 years e) Recent episode of hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose measurement (below or equal to 70 mg/dL [below or equal to 3.9 mmol/L])) within the last 12 weeks prior to Visit 1 (screening) - Male or female, age at least 18 years at the time of signing informed consent - Type 1 diabetes mellitus (diagnosed clinically) for at least 52 weeks prior to Visit 1 - Current treatment with a basal-bolus regimen consisting of neutral protamine Hagedorn (NPH) insulin OD (once daily) / BID (twice daily) or insulin detemir (IDet) OD / BID plus 2-4 daily injections of any rapid acting meal time insulin or CSII (with rapid acting insulin) for at least 26 weeks prior to Visit 1 - HbA1c (glycosylated haemoglobin) below or equal to 10% by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m^2 Exclusion Criteria: - Treatment with IGlar or IDeg within the last 26 weeks prior to Visit 1 (short term use [less than or equal to 2 weeks] is allowed, but not within 4 weeks prior to screening) - Use of any other anti-diabetic agent than those stated in the inclusion criteria within the last 26 weeks prior to Visit 1

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): NCT02034513


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02034513    
Other Study ID Numbers: NN1250-3995
U1111-1129-9668 ( Other Identifier: WHO )
2012-001930-32 ( EudraCT Number )
First Posted: January 13, 2014    Key Record Dates
Results First Posted: May 15, 2017
Last Update Posted: January 2, 2019
Last Verified: December 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs