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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02030600
First received: January 7, 2014
Last updated: November 28, 2016
Last verified: November 2016
  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 ]

Enrollment: 721
Study Start Date: January 2014
Study Completion Date: December 2015
Primary Completion Date: December 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   (Adult, Senior)
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

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Locations
United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35215-7502
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35216
Novo Nordisk Investigational Site
Haleyville, Alabama, United States, 35565-1719
Novo Nordisk Investigational Site
Montgomery, Alabama, United States, 36106
Novo Nordisk Investigational Site
Tuscumbia, Alabama, United States, 35674
United States, Arizona
Novo Nordisk Investigational Site
Chandler, Arizona, United States, 85224
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85050
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85704
United States, Arkansas
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Novo Nordisk Investigational Site
Costa Mesa, California, United States, 92626
Novo Nordisk Investigational Site
Downey, California, United States, 90242
Novo Nordisk Investigational Site
El Cajon, California, United States, 92020
Novo Nordisk Investigational Site
Fresno, California, United States, 93702
Novo Nordisk Investigational Site
Fresno, California, United States, 93720
Novo Nordisk Investigational Site
Hawaiian Gardens, California, United States, 90716
Novo Nordisk Investigational Site
Huntington Park, California, United States, 90255
Novo Nordisk Investigational Site
Huntinton Park, California, United States, 90255
Novo Nordisk Investigational Site
Lincoln, California, United States, 95648
Novo Nordisk Investigational Site
Long Beach, California, United States, 90807
Novo Nordisk Investigational Site
Montclair, California, United States, 91763
Novo Nordisk Investigational Site
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
Novo Nordisk Investigational Site
Poway, California, United States, 92064
Novo Nordisk Investigational Site
Rancho Cucamonga, California, United States, 91730-3063
Novo Nordisk Investigational Site
Rialto, California, United States, 92376
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Roseville, California, United States, 95661
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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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Torrance, California, United States, 90502
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Tustin, California, United States, 92780
United States, Colorado
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Colorado Springs, Colorado, United States, 80910
Novo Nordisk Investigational Site
Golden, Colorado, United States, 80401
United States, Delaware
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Newark, Delaware, United States, 19713
United States, Florida
Novo Nordisk Investigational Site
Bradenton, Florida, United States, 34201
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Chiefland, Florida, United States, 32626
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Clearwater, Florida, United States, 33756
Novo Nordisk Investigational Site
Clearwater, Florida, United States, 33765
Novo Nordisk Investigational Site
Cooper City, Florida, United States, 33024
Novo Nordisk Investigational Site
Doral, Florida, United States, 33166
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Hialeah, Florida, United States, 33012
Novo Nordisk Investigational Site
Hialeah, Florida, United States, 33013
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32204
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32216
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32256
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32277
Novo Nordisk Investigational Site
Miami Springs, Florida, United States, 33166
Novo Nordisk Investigational Site
Miami, Florida, United States, 33130
Novo Nordisk Investigational Site
Miami, Florida, United States, 33155
Novo Nordisk Investigational Site
Miami, Florida, United States, 33156
Novo Nordisk Investigational Site
Miami, Florida, United States, 33165
Novo Nordisk Investigational Site
Miami, Florida, United States, 33174
Novo Nordisk Investigational Site
Miami, Florida, United States, 33175
Novo Nordisk Investigational Site
Miami, Florida, United States, 33186
Novo Nordisk Investigational Site
Miramar, Florida, United States, 33027
Novo Nordisk Investigational Site
New Port Richey, Florida, United States, 34652
Novo Nordisk Investigational Site
Ocala, Florida, United States, 34471
Novo Nordisk Investigational Site
Orlando, Florida, United States, 32801
Novo Nordisk Investigational Site
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
United States, Georgia
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Perry, Georgia, United States, 31069
United States, Illinois
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Champaign, Illinois, United States, 61821
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Chicago, Illinois, United States, 60611
United States, Indiana
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Evansville, Indiana, United States, 47714
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Muncie, Indiana, United States, 47304
United States, Iowa
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Des Moines, Iowa, United States, 50314-2610
United States, Kansas
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Lenexa, Kansas, United States, 66219
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Newton, Kansas, United States, 67114
United States, Kentucky
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Lexington, Kentucky, United States, 40502
Novo Nordisk Investigational Site
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
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Shreveport, Louisiana, United States, 71105
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
United States, Missouri
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Florissant, Missouri, United States, 63031
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Jefferson City, Missouri, United States, 65109
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Kansas City, Missouri, United States, 64106
United States, Nevada
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Henderson, Nevada, United States, 89052-2649
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Las Vegas, Nevada, United States, 89148
United States, New Hampshire
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Newington, New Hampshire, United States, 03801
United States, New Jersey
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Morganville, New Jersey, United States, 07751
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Teaneck, New Jersey, United States, 07666
United States, New Mexico
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Albuquerque, New Mexico, United States, 87102
United States, New York
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Albany, New York, United States, 12208
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Jackson Heights, New York, United States, 11372
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New Windsor, New York, United States, 12553
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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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Toledo, Ohio, United States, 43614
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
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Altoona, Pennsylvania, United States, 16602
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Beaver, Pennsylvania, United States, 15009
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Philadelphia, Pennsylvania, United States, 19107
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Philadelphia, Pennsylvania, United States, 19152
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Scottdale, Pennsylvania, United States, 15683
United States, South Carolina
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Anderson, South Carolina, United States, 29621
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Gaffney, South Carolina, United States, 29341
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Greer, South Carolina, United States, 29651
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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
Novo Nordisk Investigational Site
Bristol, Tennessee, United States, 37620-7352
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Bristol, Tennessee, United States, 37620
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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
Novo Nordisk Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
Novo Nordisk Investigational Site
Arlington, Texas, United States, 76012-4637
Novo Nordisk Investigational Site
Arlington, Texas, United States, 76012
Novo Nordisk Investigational Site
Austin, Texas, United States, 78758
Novo Nordisk Investigational Site
Carrollton, Texas, United States, 75007
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Dallas, Texas, United States, 75208
Novo Nordisk Investigational Site
El Paso, Texas, United States, 79912
Novo Nordisk Investigational Site
Fort Worth, Texas, United States, 76104
Novo Nordisk Investigational Site
Houston, Texas, United States, 77043
Novo Nordisk Investigational Site
Houston, Texas, United States, 77060
Novo Nordisk Investigational Site
Houston, Texas, United States, 77070
Novo Nordisk Investigational Site
Houston, Texas, United States, 77072
Novo Nordisk Investigational Site
Houston, Texas, United States, 77074
Novo Nordisk Investigational Site
Houston, Texas, United States, 77077
Novo Nordisk Investigational Site
Humble, Texas, United States, 77338
Novo Nordisk Investigational Site
Hurst, Texas, United States, 76054
Novo Nordisk Investigational Site
Marshall, Texas, United States, 75670
Novo Nordisk Investigational Site
Mesquite, Texas, United States, 75149
Novo Nordisk Investigational Site
North Richland Hills, Texas, United States, 76180
Novo Nordisk Investigational Site
Plano, Texas, United States, 75075
Novo Nordisk Investigational Site
Plano, Texas, United States, 75093
Novo Nordisk Investigational Site
Richardson, Texas, United States, 75080
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78215
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78224
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78228-3419
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78229
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78240
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78258
Novo Nordisk Investigational Site
Sealy, Texas, United States, 77474
Novo Nordisk Investigational Site
Sugar Land, Texas, United States, 77478
Novo Nordisk Investigational Site
Sugar Land, Texas, United States, 77479
Novo Nordisk Investigational Site
Victoria, Texas, United States, 77901
Novo Nordisk Investigational Site
Waco, Texas, United States, 76710
United States, Utah
Novo Nordisk Investigational Site
Draper, Utah, United States, 84020
Novo Nordisk Investigational Site
Ogden, Utah, United States, 84405
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Novo Nordisk Investigational Site
Chesapeake, Virginia, United States, 23321
Novo Nordisk Investigational Site
Norfolk, Virginia, United States, 23510
United States, Washington
Novo Nordisk Investigational Site
Olympia, Washington, United States, 98502
Novo Nordisk Investigational Site
Renton, Washington, United States, 98057
Novo Nordisk Investigational Site
Richland, Washington, United States, 99352
Novo Nordisk Investigational Site
Spokane, Washington, United States, 99202-1334
United States, West Virginia
Novo Nordisk Investigational Site
Martinsburg, West Virginia, United States, 25401
United States, Wisconsin
Novo Nordisk Investigational Site
Kenosha, Wisconsin, United States, 53142
Puerto Rico
Novo Nordisk Investigational Site
Carolina, Puerto Rico, 00983
Novo Nordisk Investigational Site
Manati, Puerto Rico, 00674
Novo Nordisk Investigational Site
Ponce, Puerto Rico, 00717
Novo Nordisk Investigational Site
San Juan, Puerto Rico, 00918
Novo Nordisk Investigational Site
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:
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: November 28, 2016
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
Insulin, Globin Zinc
Insulin
Insulin Glargine
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016