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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

Tracking Information
First Submitted Date  ICMJE January 7, 2014
First Posted Date  ICMJE January 13, 2014
Results First Submitted Date  ICMJE January 11, 2017
Results First Posted Date  ICMJE May 15, 2017
Last Update Posted Date January 2, 2019
Actual Study Start Date  ICMJE January 5, 2014
Actual Primary Completion Date January 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period [ Time Frame: A 16 week treatment period ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • FPG (Fasting Plasma Glucose) [ Time Frame: Week 32 and Week 64 ]
    Fasting plasma glucose values at week 32 and week 64.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
  • 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) ]
  • 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) ]
  • Incidence of Treatment Emergent Adverse Events [ Time Frame: During 32 weeks of treatment for each treatment period ]
  • Change From Baseline in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 32, Week 64 ]
  • FPG (Fasting Plasma Glucose) [ Time Frame: Week 32, Week 64 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 1
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: insulin degludec
    • Drug: insulin glargine
    • Drug: insulin aspart
  • 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
    Interventions:
    • Drug: insulin degludec
    • Drug: insulin glargine
    • Drug: insulin aspart
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2016)
501
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2014)
446
Actual Study Completion Date  ICMJE January 11, 2016
Actual Primary Completion Date January 11, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02034513
Other Study ID Numbers  ICMJE NN1250-3995
U1111-1129-9668 ( Other Identifier: WHO )
2012-001930-32 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP