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A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes (SWITCH 2)

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ClinicalTrials.gov Identifier: NCT02030600
Recruitment Status : Completed
First Posted : January 8, 2014
Results First Posted : January 30, 2017
Last Update Posted : May 10, 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 8, 2014
Results First Submitted Date  ICMJE December 2, 2016
Results First Posted Date  ICMJE January 30, 2017
Last Update Posted Date May 10, 2019
Actual Study Start Date  ICMJE January 6, 2014
Actual Primary Completion Date December 4, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2016)
Number of Treatment Emergent Severe or BG Confirmed Symptomatic 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 blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2014)
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period [ Time Frame: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2016)
  • Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episode 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 <56 mg/dL (3.1 mmol/L), 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 value was considered as baseline for calculating change from baseline in HbA1c at week 64.
  • FPG (Fasting Plasma Glucose) [ Time Frame: week 32, week 64 ]
    Fasting plasma glucose values at week 32 and week 64.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2014)
  • Number of treatment emergent severe or BG confirmed symptomatic nocturnal hypoglycaemic 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, With or Without OADs in Subjects With Type 2 Diabetes
Official Title  ICMJE A Randomised, Double Blind, Cross-over Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes (SWITCH 2)
Brief Summary This trial is conducted in 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) with or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides in subjects with type 2 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 2
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.
Study Arms  ICMJE
  • Experimental: IDeg OD ± OADs followed by IGlar OD ± OADs
    The trial includes two 32-week treatment periods in a cross-over design. Total trial duration for the individual subjects will be up to 67 weeks.
    Interventions:
    • Drug: insulin degludec
    • Drug: insulin glargine
  • Active Comparator: IGlar OD ± OADs followed by IDeg OD ± OADs
    The trial includes two 32-week treatment periods in a cross-over design. Total trial duration for the individual subjects will be up to 67 weeks.
    Interventions:
    • Drug: insulin degludec
    • Drug: insulin glargine
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: November 28, 2016)
721
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2014)
668
Actual Study Completion Date  ICMJE December 4, 2015
Actual Primary Completion Date December 4, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Subjects fulfilling at least one of the below criteria: a) Experienced at least one severe hypoglycaemic episode within 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) by central laboratory analysis, c) Hypoglycaemic symptom unawareness, d) Exposed to insulin for more than 5 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) - Type 2 diabetes mellitus (diagnosed clinically) for at least 26 weeks prior to Visit 1 - Current treatment with any basal insulin (OD or BID) ± any combination of OADs (metformin, DPP-4 inhibitor, alpha-glucosidase inhibitor, thiazolidinediones, and SGLT2-inhibitor) for 26 weeks or longer prior to Visit 1 For subjects on BID the total daily dose should be below 75 units - HbA1c (glycosylated haemoglobin) below or equal to 9.5 % by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m^2 Exclusion Criteria: - Treatment with a bolus insulin separately or contained in an insulin mix product within the last 26 weeks prior to Visit 1 - Use of any other anti-diabetic agent(s) 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 Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02030600
Other Study ID Numbers  ICMJE NN1250-3998
U1111-1143-7963 ( Other Identifier: WHO )
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 April 2019

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