Diabetes Mellitus, Type 2 Clinical Trial
— SWITCH 2Official 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)
| Verified date | April 2019 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 721 |
| Est. completion date | December 4, 2015 |
| Est. primary completion date | December 4, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Novo Nordisk Investigational Site | Carolina | |
| Puerto Rico | Novo Nordisk Investigational Site | Manati | |
| Puerto Rico | Novo Nordisk Investigational Site | Ponce | |
| Puerto Rico | Novo Nordisk Investigational Site | San Juan | |
| Puerto Rico | Novo Nordisk Investigational Site | San Juan | |
| United States | Novo Nordisk Investigational Site | Albany | New York |
| United States | Novo Nordisk Investigational Site | Albuquerque | New Mexico |
| United States | Novo Nordisk Investigational Site | Altoona | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Anderson | South Carolina |
| United States | Novo Nordisk Investigational Site | Arlington | Texas |
| United States | Novo Nordisk Investigational Site | Arlington | Texas |
| United States | Novo Nordisk Investigational Site | Austin | Texas |
| United States | Novo Nordisk Investigational Site | Beaver | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Birmingham | Alabama |
| United States | Novo Nordisk Investigational Site | Birmingham | Alabama |
| United States | Novo Nordisk Investigational Site | Bradenton | Florida |
| United States | Novo Nordisk Investigational Site | Bristol | Tennessee |
| United States | Novo Nordisk Investigational Site | Bristol | Tennessee |
| United States | Novo Nordisk Investigational Site | Brockton | Massachusetts |
| United States | Novo Nordisk Investigational Site | Carrollton | Texas |
| United States | Novo Nordisk Investigational Site | Champaign | Illinois |
| United States | Novo Nordisk Investigational Site | Chandler | Arizona |
| United States | Novo Nordisk Investigational Site | Charlotte | North Carolina |
| United States | Novo Nordisk Investigational Site | Chattanooga | Tennessee |
| United States | Novo Nordisk Investigational Site | Chesapeake | Virginia |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Chiefland | Florida |
| United States | Novo Nordisk Investigational Site | Clearwater | Florida |
| United States | Novo Nordisk Investigational Site | Clearwater | Florida |
| United States | Novo Nordisk Investigational Site | Colorado Springs | Colorado |
| United States | Novo Nordisk Investigational Site | Cooper City | Florida |
| United States | Novo Nordisk Investigational Site | Costa Mesa | California |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Delaware | Ohio |
| United States | Novo Nordisk Investigational Site | Doral | Florida |
| United States | Novo Nordisk Investigational Site | Downey | California |
| United States | Novo Nordisk Investigational Site | Draper | Utah |
| United States | Novo Nordisk Investigational Site | El Cajon | California |
| United States | Novo Nordisk Investigational Site | El Paso | Texas |
| United States | Novo Nordisk Investigational Site | Evansville | Indiana |
| United States | Novo Nordisk Investigational Site | Florissant | Missouri |
| United States | Novo Nordisk Investigational Site | Fort Worth | Texas |
| United States | Novo Nordisk Investigational Site | Franklin | Ohio |
| United States | Novo Nordisk Investigational Site | Fresno | California |
| United States | Novo Nordisk Investigational Site | Fresno | California |
| United States | Novo Nordisk Investigational Site | Gaffney | South Carolina |
| United States | Novo Nordisk Investigational Site | Golden | Colorado |
| United States | Novo Nordisk Investigational Site | Greer | South Carolina |
| United States | Novo Nordisk Investigational Site | Haleyville | Alabama |
| United States | Novo Nordisk Investigational Site | Hawaiian Gardens | California |
| United States | Novo Nordisk Investigational Site | Henderson | Nevada |
| United States | Novo Nordisk Investigational Site | Hialeah | Florida |
| United States | Novo Nordisk Investigational Site | Hialeah | Florida |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Humble | Texas |
| United States | Novo Nordisk Investigational Site | Humboldt | Tennessee |
| United States | Novo Nordisk Investigational Site | Huntington Park | California |
| United States | Novo Nordisk Investigational Site | Hurst | Texas |
| United States | Novo Nordisk Investigational Site | Jackson | Tennessee |
| United States | Novo Nordisk Investigational Site | Jackson Heights | New York |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Jefferson City | Missouri |
| United States | Novo Nordisk Investigational Site | Johnson City | Tennessee |
| United States | Novo Nordisk Investigational Site | Kalamazoo | Michigan |
| United States | Novo Nordisk Investigational Site | Kansas City | Missouri |
| United States | Novo Nordisk Investigational Site | Kenosha | Wisconsin |
| United States | Novo Nordisk Investigational Site | Kingsport | Tennessee |
| United States | Novo Nordisk Investigational Site | Las Vegas | Nevada |
| United States | Novo Nordisk Investigational Site | Lenexa | Kansas |
| United States | Novo Nordisk Investigational Site | Lexington | Kentucky |
| United States | Novo Nordisk Investigational Site | Lexington | Kentucky |
| United States | Novo Nordisk Investigational Site | Lincoln | California |
| United States | Novo Nordisk Investigational Site | Little Rock | Arkansas |
| United States | Novo Nordisk Investigational Site | Long Beach | California |
| United States | Novo Nordisk Investigational Site | Louisville | Kentucky |
| United States | Novo Nordisk Investigational Site | Marshall | Texas |
| United States | Novo Nordisk Investigational Site | Martinsburg | West Virginia |
| United States | Novo Nordisk Investigational Site | Mesquite | Texas |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami Springs | Florida |
| United States | Novo Nordisk Investigational Site | Miramar | Florida |
| United States | Novo Nordisk Investigational Site | Montclair | California |
| United States | Novo Nordisk Investigational Site | Montgomery | Alabama |
| United States | Novo Nordisk Investigational Site | Morganton | North Carolina |
| United States | Novo Nordisk Investigational Site | Morganville | New Jersey |
| United States | Novo Nordisk Investigational Site | Muncie | Indiana |
| United States | Novo Nordisk Investigational Site | New Orleans | Louisiana |
| United States | Novo Nordisk Investigational Site | New Port Richey | Florida |
| United States | Novo Nordisk Investigational Site | New Windsor | New York |
| United States | Novo Nordisk Investigational Site | Newark | Delaware |
| United States | Novo Nordisk Investigational Site | Newington | New Hampshire |
| United States | Novo Nordisk Investigational Site | Newton | Kansas |
| United States | Novo Nordisk Investigational Site | Norfolk | Virginia |
| United States | Novo Nordisk Investigational Site | North Hollywood | California |
| United States | Novo Nordisk Investigational Site | North Richland Hills | Texas |
| United States | Novo Nordisk Investigational Site | Northport | New York |
| United States | Novo Nordisk Investigational Site | Northridge | California |
| United States | Novo Nordisk Investigational Site | Ocala | Florida |
| United States | Novo Nordisk Investigational Site | Ogden | Utah |
| United States | Novo Nordisk Investigational Site | Oklahoma City | Oklahoma |
| United States | Novo Nordisk Investigational Site | Olive Branch | Mississippi |
| United States | Novo Nordisk Investigational Site | Olympia | Washington |
| United States | Novo Nordisk Investigational Site | Orlando | Florida |
| United States | Novo Nordisk Investigational Site | Paducah | Kentucky |
| United States | Novo Nordisk Investigational Site | Panama City | Florida |
| United States | Novo Nordisk Investigational Site | Pelzer | South Carolina |
| United States | Novo Nordisk Investigational Site | Pembroke Pines | Florida |
| United States | Novo Nordisk Investigational Site | Perry | Georgia |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Phoenix | Arizona |
| United States | Novo Nordisk Investigational Site | Plano | Texas |
| United States | Novo Nordisk Investigational Site | Plano | Texas |
| United States | Novo Nordisk Investigational Site | Pomona | California |
| United States | Novo Nordisk Investigational Site | Poway | California |
| United States | Novo Nordisk Investigational Site | Rancho Cucamonga | California |
| United States | Novo Nordisk Investigational Site | Rapid City | South Dakota |
| United States | Novo Nordisk Investigational Site | Renton | Washington |
| United States | Novo Nordisk Investigational Site | Rialto | California |
| United States | Novo Nordisk Investigational Site | Richardson | Texas |
| United States | Novo Nordisk Investigational Site | Richland | Washington |
| United States | Novo Nordisk Investigational Site | Roseville | California |
| United States | Novo Nordisk Investigational Site | Salt Lake City | Utah |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Antonio | Texas |
| United States | Novo Nordisk Investigational Site | San Diego | California |
| United States | Novo Nordisk Investigational Site | Santa Monica | California |
| United States | Novo Nordisk Investigational Site | Scottdale | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Sealy | Texas |
| United States | Novo Nordisk Investigational Site | Shreveport | Louisiana |
| United States | Novo Nordisk Investigational Site | Smithtown | New York |
| United States | Novo Nordisk Investigational Site | Spartanburg | South Carolina |
| United States | Novo Nordisk Investigational Site | Spokane | Washington |
| United States | Novo Nordisk Investigational Site | Sugar Land | Texas |
| United States | Novo Nordisk Investigational Site | Sugar Land | Texas |
| United States | Novo Nordisk Investigational Site | Tampa | Florida |
| United States | Novo Nordisk Investigational Site | Tampa | Florida |
| United States | Novo Nordisk Investigational Site | Tarzana | California |
| United States | Novo Nordisk Investigational Site | Teaneck | New Jersey |
| United States | Novo Nordisk Investigational Site | Toledo | Ohio |
| United States | Novo Nordisk Investigational Site | Torrance | California |
| United States | Novo Nordisk Investigational Site | Tucson | Arizona |
| United States | Novo Nordisk Investigational Site | Tuscumbia | Alabama |
| United States | Novo Nordisk Investigational Site | Tustin | California |
| United States | Novo Nordisk Investigational Site | Victoria | Texas |
| United States | Novo Nordisk Investigational Site | Waco | Texas |
| United States | Novo Nordisk Investigational Site | West Des Moines | Iowa |
| United States | Novo Nordisk Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Puerto Rico,
Chaykin L, Bhargava A, de la Rosa R, Wysham CH, Nørgård Troelsen L, Østoft SH, Philis-Tsimikas A. Effect of Insulin Degludec Versus Insulin Glargine U100 on Hypoglycemia in Hispanic Patients With Type 2 Diabetes: Results From the SWITCH 2 Trial. Clin Diabetes. 2019 Jan;37(1):73-81. doi: 10.2337/cd18-0016. — View Citation
DeVries JH, Bailey TS, Bhargava A, Gerety G, Gumprecht J, Heller S, Lane W, Wysham CH, Zinman B, Bak BA, Hachmann-Nielsen E, Philis-Tsimikas A. Day-to-day fasting self-monitored blood glucose variability is associated with risk of hypoglycaemia in insulin — View Citation
Evans M, Mehta R, Gundgaard J, Chubb B. Cost-Effectiveness of Insulin Degludec vs. Insulin Glargine U100 in Type 1 and Type 2 Diabetes Mellitus in a UK Setting. Diabetes Ther. 2018 Oct;9(5):1919-1930. doi: 10.1007/s13300-018-0478-1. Epub 2018 Aug 10. — View Citation
Heller SR, DeVries JH, Wysham C, Hansen CT, Hansen MV, Frier BM. Lower rates of hypoglycaemia in older individuals with type 2 diabetes using insulin degludec versus insulin glargine U100: Results from SWITCH 2. Diabetes Obes Metab. 2019 Mar 20. doi: 10.1 — View Citation
Wysham C, Bhargava A, Chaykin L, de la Rosa R, Handelsman Y, Troelsen LN, Kvist K, Norwood P. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 2 Diabetes: The SWITCH 2 Randomized Clinical Trial. JAMA. 2017 Jul 4;31 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance 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 <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. | After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64) | |
| Secondary | Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episode During the Maintenance Period | 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. | After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64) | |
| Secondary | Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period | 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. | After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64) | |
| Secondary | Incidence of Treatment Emergent Adverse Events | 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. | During 32 weeks of treatment for each treatment period | |
| Secondary | Change From Baseline in HbA1c (Glycosylated Haemoglobin) | 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. | Week 32, Week 64 | |
| Secondary | FPG (Fasting Plasma Glucose) | Fasting plasma glucose values at week 32 and week 64. | week 32, week 64 |
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