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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Novo Nordisk A/S
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02030600
First received: January 7, 2014
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin degludec
Drug: insulin glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Incidence of treatment emergent adverse events [ Time Frame: During 32 weeks of treatment for each treatment period ] [ Designated as safety issue: No ]
  • Change from baseline in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 32, Week 64 ] [ Designated as safety issue: No ]
  • FPG (fasting plasma glucose) [ Time Frame: Week 32, Week 64 ] [ Designated as safety issue: No ]

Estimated Enrollment: 668
Study Start Date: January 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02030600

Contacts
Contact: Novo Nordisk clinicaltrials@novonordisk.com

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Locations
United States, Alabama
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Birmingham, Alabama, United States, 35216
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Birmingham, Alabama, United States, 35215-7502
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Haleyville, Alabama, United States, 35565-1719
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Montgomery, Alabama, United States, 36106-1509
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Muscle Shoals, Alabama, United States, 35662
United States, Arizona
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Phoenix, Arizona, United States, 85050
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Phoenix, Arizona, United States, 85013
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Tucson, Arizona, United States, 85704
United States, Arkansas
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Little Rock, Arkansas, United States, 72205
United States, California
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Chino, California, United States, 91710
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Costa Mesa, California, United States, 92626
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Downey, California, United States, 90242
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El Cajon, California, United States, 92020
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Fair Oaks, California, United States, 95628
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Fresno, California, United States, 93702
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Fresno, California, United States, 93720
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Hawaiian Gardens, California, United States, 90716
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Huntington Park, California, United States, 90255
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Huntinton Park, California, United States, 90255
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Lincoln, California, United States, 95648
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Long Beach, California, United States, 90807
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North Hollywood, California, United States, 91606
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Northridge, California, United States, 91325
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Pomona, California, United States, 91766-1854
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Rancho Cucamonga, California, United States, 91730-3063
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Rialto, California, United States, 92376
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San Diego, California, United States, 92111
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Santa Monica, California, United States, 90404
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Tarzana, California, United States, 91356-3551
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Tustin, California, United States, 92780
United States, Colorado
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Golden, Colorado, United States, 80401
United States, Delaware
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Newark, Delaware, United States, 19713
United States, Florida
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Bradenton, Florida, United States, 34208
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Chiefland, Florida, United States, 32626
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Clearwater, Florida, United States, 33765
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Clearwater, Florida, United States, 33756
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Cooper City, Florida, United States, 33024
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Doral, Florida, United States, 33166
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Doral, Florida, United States, 33172
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Hialeah, Florida, United States, 33016
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Hialeah, Florida, United States, 33012
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Jacksonville, Florida, United States, 32204
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Jacksonville, Florida, United States, 32256
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Jacksonville, Florida, United States, 32216
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Jacksonville, Florida, United States, 32277
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Miami, Florida, United States, 33155
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Miami, Florida, United States, 33130
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Miami, Florida, United States, 33174
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Miami, Florida, United States, 33175
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Miami, Florida, United States, 33156
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Miami, Florida, United States, 33186
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Miami Springs, Florida, United States, 33166
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Miramar, Florida, United States, 33027
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New Port Richey, Florida, United States, 34652
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Ocala, Florida, United States, 34471
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Orlando, Florida, United States, 32801
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Panama City, Florida, United States, 32401
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Pembroke Pines, Florida, United States, 33026
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Tampa, Florida, United States, 33607
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Tampa, Florida, United States, 33619
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Perry, Georgia, United States, 31069
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Champaign, Illinois, United States, 61820
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Chicago, Illinois, United States, 60611
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Evansville, Indiana, United States, 47714
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Muncie, Indiana, United States, 47304
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Des Moines, Iowa, United States, 50314-2610
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Lenexa, Kansas, United States, 66219
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Newton, Kansas, United States, 67114
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Lexington, Kentucky, United States, 40502
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Lexington, Kentucky, United States, 40503
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Louisville, Kentucky, United States, 40218
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Paducah, Kentucky, United States, 42003
United States, Louisiana
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New Orleans, Louisiana, United States, 70119
United States, Massachusetts
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Brockton, Massachusetts, United States, 02301
United States, Michigan
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Kalamazoo, Michigan, United States, 49009
United States, Mississippi
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Olive Branch, Mississippi, United States, 38654-3573
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Florissant, Missouri, United States, 63031
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Jefferson City, Missouri, United States, 65109-6001
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Kansas City, Missouri, United States, 64106
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Henderson, Nevada, United States, 89052-2649
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Las Vegas, Nevada, United States, 89148
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Morganville, New Jersey, United States, 07751
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Teaneck, New Jersey, United States, 07666
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Jackson Heights, New York, United States, 11372
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Northport, New York, United States, 11768
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Smithtown, New York, United States, 11787
United States, North Carolina
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Charlotte, North Carolina, United States, 28277
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Morganton, North Carolina, United States, 28655
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Winston Salem, North Carolina, United States, 27103
United States, Ohio
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Delaware, Ohio, United States, 43015
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Franklin, Ohio, United States, 45005
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United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
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Beaver, Pennsylvania, United States, 15009
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Philadelphia, Pennsylvania, United States, 19152
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Philadelphia, Pennsylvania, United States, 19107
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Scottdale, Pennsylvania, United States, 15683
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Tipton, Pennsylvania, United States, 16684
United States, South Carolina
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Gaffney, South Carolina, United States, 29341
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Greenville, South Carolina, United States, 29615
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Pelzer, South Carolina, United States, 29669
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Spartanburg, South Carolina, United States, 29303
United States, South Dakota
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Rapid City, South Dakota, United States, 57701
United States, Tennessee
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Bristol, Tennessee, United States, 37620
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Bristol, Tennessee, United States, 37620-7352
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Chattanooga, Tennessee, United States, 37404
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Humboldt, Tennessee, United States, 38343
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Jackson, Tennessee, United States, 38305
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Johnson City, Tennessee, United States, 37604
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Kingsport, Tennessee, United States, 37660
United States, Texas
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Arlington, Texas, United States, 76012-4637
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Arlington, Texas, United States, 76012
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Austin, Texas, United States, 78758
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Carrollton, Texas, United States, 75007
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Dallas, Texas, United States, 75208
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El Paso, Texas, United States, 79925
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Fort Worth, Texas, United States, 76104
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Houston, Texas, United States, 77072
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Houston, Texas, United States, 77070
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Houston, Texas, United States, 77036
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Houston, Texas, United States, 77043
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Houston, Texas, United States, 77060
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Houston, Texas, United States, 77077
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Humble, Texas, United States, 77338
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Hurst, Texas, United States, 76054
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Marshall, Texas, United States, 75670
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Mesquite, Texas, United States, 75149
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North Richland Hills, Texas, United States, 76180
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Plano, Texas, United States, 75093
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Plano, Texas, United States, 75075
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San Antonio, Texas, United States, 78215
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San Antonio, Texas, United States, 78258
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San Antonio, Texas, United States, 78240
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San Antonio, Texas, United States, 78228-3419
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San Antonio, Texas, United States, 78224
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San Antonio, Texas, United States, 78229
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Sealy, Texas, United States, 77474
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Sugar Land, Texas, United States, 77479
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Sugarland, Texas, United States, 77478
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Victoria, Texas, United States, 77901
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Waco, Texas, United States, 76710
United States, Utah
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Draper, Utah, United States, 84020
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Ogden, Utah, United States, 84405
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Salt Lake City, Utah, United States, 84107
United States, Virginia
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Chesapeake, Virginia, United States, 23321
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Norfolk, Virginia, United States, 23510
United States, Washington
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Olympia, Washington, United States, 98502
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Renton, Washington, United States, 98057
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Spokane, Washington, United States, 99202-1334
United States, West Virginia
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Martinsburg, West Virginia, United States, 25401
United States, Wisconsin
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Kenosha, Wisconsin, United States, 53142-7884
Puerto Rico
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Carolina, Puerto Rico, 00983
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Manati, Puerto Rico, 00674
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Ponce, Puerto Rico, 00717
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San Juan, Puerto Rico, 00918
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San Juan, Puerto Rico, 00921
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02030600     History of Changes
Other Study ID Numbers: NN1250-3998, U1111-1143-7963
Study First Received: January 7, 2014
Last Updated: July 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014