DiabetesPhase 3SWITCH 2NCT02030600

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

A Phase 3 study testing insulin degludec and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 166 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: insulin degludec and insulin glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 721 participants
Where: 166 sitesin 2 countries
Study dates: 6 Jan 2014to 4 Dec 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

166 sites in 2 countries.

Country

City, postcode or hospital

166 sites in 2 countries

United States161 sites

Novo Nordisk Investigational Site
Albany, New York, 12208
Novo Nordisk Investigational Site
Albuquerque, New Mexico, 87102
Novo Nordisk Investigational Site
Altoona, Pennsylvania, 16602
Novo Nordisk Investigational Site
Anderson, South Carolina, 29621
Novo Nordisk Investigational Site
Arlington, Texas, 76012-4637
Novo Nordisk Investigational Site
Arlington, Texas, 76012
Novo Nordisk Investigational Site
Austin, Texas, 78758
Novo Nordisk Investigational Site
Beaver, Pennsylvania, 15009
Novo Nordisk Investigational Site
Birmingham, Alabama, 35215-7502
Novo Nordisk Investigational Site
Birmingham, Alabama, 35216
Novo Nordisk Investigational Site
Bradenton, Florida, 34201
Novo Nordisk Investigational Site
Bristol, Tennessee, 37620-7352
Novo Nordisk Investigational Site
Bristol, Tennessee, 37620
Novo Nordisk Investigational Site
Brockton, Massachusetts, 02301
Novo Nordisk Investigational Site
Carrollton, Texas, 75007
Novo Nordisk Investigational Site
Champaign, Illinois, 61821
Novo Nordisk Investigational Site
Chandler, Arizona, 85224
Novo Nordisk Investigational Site
Charlotte, North Carolina, 28277
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404
Novo Nordisk Investigational Site
Chesapeake, Virginia, 23321
Novo Nordisk Investigational Site
Chicago, Illinois, 60611
Novo Nordisk Investigational Site
Chiefland, Florida, 32626
Novo Nordisk Investigational Site
Clearwater, Florida, 33756
Novo Nordisk Investigational Site
Clearwater, Florida, 33765
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80910
Novo Nordisk Investigational Site
Cooper City, Florida, 33024
Novo Nordisk Investigational Site
Costa Mesa, California, 92626
Novo Nordisk Investigational Site
Dallas, Texas, 75208
Novo Nordisk Investigational Site
Delaware, Ohio, 43015
Novo Nordisk Investigational Site
Doral, Florida, 33166
Novo Nordisk Investigational Site
Downey, California, 90242
Novo Nordisk Investigational Site
Draper, Utah, 84020
Novo Nordisk Investigational Site
El Cajon, California, 92020
Novo Nordisk Investigational Site
El Paso, Texas, 79912
Novo Nordisk Investigational Site
Evansville, Indiana, 47714
Novo Nordisk Investigational Site
Florissant, Missouri, 63031
Novo Nordisk Investigational Site
Fort Worth, Texas, 76104
Novo Nordisk Investigational Site
Franklin, Ohio, 45005
Novo Nordisk Investigational Site
Fresno, California, 93702
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Gaffney, South Carolina, 29341
Novo Nordisk Investigational Site
Golden, Colorado, 80401
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Haleyville, Alabama, 35565-1719
Novo Nordisk Investigational Site
Hawaiian Gardens, California, 90716
Novo Nordisk Investigational Site
Henderson, Nevada, 89052-2649
Novo Nordisk Investigational Site
Hialeah, Florida, 33012
Novo Nordisk Investigational Site
Hialeah, Florida, 33013
Novo Nordisk Investigational Site
Houston, Texas, 77040
Novo Nordisk Investigational Site
Houston, Texas, 77043
Novo Nordisk Investigational Site
Houston, Texas, 77060
Novo Nordisk Investigational Site
Houston, Texas, 77070
Novo Nordisk Investigational Site
Houston, Texas, 77072
Novo Nordisk Investigational Site
Houston, Texas, 77077
Novo Nordisk Investigational Site
Humble, Texas, 77338
Novo Nordisk Investigational Site
Humboldt, Tennessee, 38343
Novo Nordisk Investigational Site
Huntington Park, California, 90255
Novo Nordisk Investigational Site
Hurst, Texas, 76054
Novo Nordisk Investigational Site
Jackson, Tennessee, 38305
Novo Nordisk Investigational Site
Jackson Heights, New York, 11372
Novo Nordisk Investigational Site
Jacksonville, Florida, 32204
Novo Nordisk Investigational Site
Jacksonville, Florida, 32216
Novo Nordisk Investigational Site
Jacksonville, Florida, 32256
Novo Nordisk Investigational Site
Jacksonville, Florida, 32277
Novo Nordisk Investigational Site
Jefferson City, Missouri, 65109
Novo Nordisk Investigational Site
Johnson City, Tennessee, 37604
Novo Nordisk Investigational Site
Kalamazoo, Michigan, 49009
Novo Nordisk Investigational Site
Kansas City, Missouri, 64106
Novo Nordisk Investigational Site
Kenosha, Wisconsin, 53144
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89148
Novo Nordisk Investigational Site
Lenexa, Kansas, 66219
Novo Nordisk Investigational Site
Lexington, Kentucky, 40502
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Lincoln, California, 95648
Novo Nordisk Investigational Site
Little Rock, Arkansas, 72205
Novo Nordisk Investigational Site
Long Beach, California, 90807
Novo Nordisk Investigational Site
Louisville, Kentucky, 40213
Novo Nordisk Investigational Site
Marshall, Texas, 75670
Novo Nordisk Investigational Site
Martinsburg, West Virginia, 25401
Novo Nordisk Investigational Site
Mesquite, Texas, 75149
Novo Nordisk Investigational Site
Miami, Florida, 33130
Novo Nordisk Investigational Site
Miami, Florida, 33155
Novo Nordisk Investigational Site
Miami, Florida, 33156
Novo Nordisk Investigational Site
Miami, Florida, 33165
Novo Nordisk Investigational Site
Miami, Florida, 33174
Novo Nordisk Investigational Site
Miami, Florida, 33175
Novo Nordisk Investigational Site
Miami, Florida, 33186
Novo Nordisk Investigational Site
Miami Springs, Florida, 33166
Novo Nordisk Investigational Site
Miramar, Florida, 33027
Novo Nordisk Investigational Site
Montclair, California, 91763
Novo Nordisk Investigational Site
Montgomery, Alabama, 36106
Novo Nordisk Investigational Site
Morganton, North Carolina, 28655
Novo Nordisk Investigational Site
Morganville, New Jersey, 07751
Novo Nordisk Investigational Site
Muncie, Indiana, 47304
Novo Nordisk Investigational Site
New Orleans, Louisiana, 70119
Novo Nordisk Investigational Site
New Port Richey, Florida, 34652
Novo Nordisk Investigational Site
New Windsor, New York, 12553
Novo Nordisk Investigational Site
Newark, Delaware, 19713
Novo Nordisk Investigational Site
Newington, New Hampshire, 03801
Novo Nordisk Investigational Site
Newton, Kansas, 67114
Novo Nordisk Investigational Site
Norfolk, Virginia, 23510
Novo Nordisk Investigational Site
North Hollywood, California, 91606
Novo Nordisk Investigational Site
North Richland Hills, Texas, 76180
Novo Nordisk Investigational Site
Northport, New York, 11768
Novo Nordisk Investigational Site
Northridge, California, 91325
Novo Nordisk Investigational Site
Ocala, Florida, 34470
Novo Nordisk Investigational Site
Ogden, Utah, 84405
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73103
Novo Nordisk Investigational Site
Olive Branch, Mississippi, 38654-3573
Novo Nordisk Investigational Site
Olympia, Washington, 98502
Novo Nordisk Investigational Site
Orlando, Florida, 32801
Novo Nordisk Investigational Site
Paducah, Kentucky, 42003
Novo Nordisk Investigational Site
Panama City, Florida, 32401
Novo Nordisk Investigational Site
Pelzer, South Carolina, 29669
Novo Nordisk Investigational Site
Pembroke Pines, Florida, 33026
Novo Nordisk Investigational Site
Perry, Georgia, 31069
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19114
Novo Nordisk Investigational Site
Phoenix, Arizona, 85050
Novo Nordisk Investigational Site
Plano, Texas, 75075
Novo Nordisk Investigational Site
Plano, Texas, 75093
Novo Nordisk Investigational Site
Pomona, California, 91766-2007
Novo Nordisk Investigational Site
Poway, California, 92064
Novo Nordisk Investigational Site
Rancho Cucamonga, California, 91730-3063
Novo Nordisk Investigational Site
Rapid City, South Dakota, 57701
Novo Nordisk Investigational Site
Renton, Washington, 98057
Novo Nordisk Investigational Site
Rialto, California, 92376
Novo Nordisk Investigational Site
Richardson, Texas, 75080
Novo Nordisk Investigational Site
Richland, Washington, 99352
Novo Nordisk Investigational Site
Roseville, California, 95661
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84107
Novo Nordisk Investigational Site
San Antonio, Texas, 78215
Novo Nordisk Investigational Site
San Antonio, Texas, 78224
Novo Nordisk Investigational Site
San Antonio, Texas, 78228-3419
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
San Antonio, Texas, 78240
Novo Nordisk Investigational Site
San Antonio, Texas, 78258
Novo Nordisk Investigational Site
San Diego, California, 92111
Novo Nordisk Investigational Site
Santa Monica, California, 90404
Novo Nordisk Investigational Site
Scottdale, Pennsylvania, 15683
Novo Nordisk Investigational Site
Sealy, Texas, 77474
Novo Nordisk Investigational Site
Shreveport, Louisiana, 71105
Novo Nordisk Investigational Site
Smithtown, New York, 11787
Novo Nordisk Investigational Site
Spartanburg, South Carolina, 29303
Novo Nordisk Investigational Site
Spokane, Washington, 99202-1334
Novo Nordisk Investigational Site
Sugar Land, Texas, 77478
Novo Nordisk Investigational Site
Sugar Land, Texas, 77479
Novo Nordisk Investigational Site
Tampa, Florida, 33607
Novo Nordisk Investigational Site
Tampa, Florida, 33619
Novo Nordisk Investigational Site
Tarzana, California, 91356-3551
Novo Nordisk Investigational Site
Teaneck, New Jersey, 07666
Novo Nordisk Investigational Site
Toledo, Ohio, 43614
Novo Nordisk Investigational Site
Torrance, California, 90502
Novo Nordisk Investigational Site
Tucson, Arizona, 85704
Novo Nordisk Investigational Site
Tuscumbia, Alabama, 35674
Novo Nordisk Investigational Site
Tustin, California, 92780
Novo Nordisk Investigational Site
Victoria, Texas, 77901
Novo Nordisk Investigational Site
Waco, Texas, 76710
Novo Nordisk Investigational Site
West Des Moines, Iowa, 50265
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Puerto Rico5 sites

Novo Nordisk Investigational Site
Carolina, 00983
Novo Nordisk Investigational Site
Manati, 00674
Novo Nordisk Investigational Site
Ponce, 00717
Novo Nordisk Investigational Site
San Juan, 00918
Novo Nordisk Investigational Site
San Juan, 00921

Other trials in Puerto Rico

About this study

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)

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec, insulin glargine
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

insulin degludecDrug
Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.
insulin glargineDrug
Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

Study groups in NCT02030600
Study group	Role	What they receive
IDeg OD ± OADs followed by IGlar OD ± OADs	Experimental	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. Receives: Drug: insulin degludec; Drug: insulin glargine
IGlar OD ± OADs followed by IDeg OD ± OADs	Active comparator	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. Receives: Drug: insulin degludec; Drug: insulin glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)

Secondary outcomes (5)

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.
Measured: 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
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.
Measured: After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)
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.
Measured: During 32 weeks of treatment for each treatment period
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.
Measured: Week 32, Week 64
FPG (Fasting Plasma Glucose)
Fasting plasma glucose values at week 32 and week 64.
Measured: week 32, week 64

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 20144 Dec 2015

First posted8 Jan 2014 (estimated)
Study start6 Jan 2014
Primary completion4 Dec 2015
Study completion4 Dec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 721 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02030600
Sponsor's protocol ID: NN1250-3998
Other IDs: U1111-1143-7963
Acronym: SWITCH 2
Status last verified: Apr 2019
First submitted: 7 Jan 2014
Last updated: 10 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Chaykin L, Bhargava A, de la Rosa R, Wysham CH, Norgard Troelsen L, Ostoft 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.
PubMed 30705500
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;318(1):45-56. doi: 10.1001/jama.2017.7117.
PubMed 28672317
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.
PubMed 30097995
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-treated patients with type 1 and type 2 diabetes: A post hoc analysis of the SWITCH Trials. Diabetes Obes Metab. 2019 Mar;21(3):622-630. doi: 10.1111/dom.13565. Epub 2018 Nov 26.
PubMed 30362250
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 Jul;21(7):1634-1641. doi: 10.1111/dom.13708. Epub 2019 Apr 15.
PubMed 30891886

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT02030600
Acronym / sponsor ID: SWITCH 2 / NN1250-3998
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 721 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 6 Jan 2014 (actual)
Primary completion: 4 Dec 2015 (actual)
Study completion: 4 Dec 2015 (actual)
First posted: 8 Jan 2014 (estimated)
Results: Posted 30 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
IDeg OD ± OADs followed by IGlar OD ± OADs	Experimental	Drug: insulin degludec, Drug: insulin glargineThe 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.
IGlar OD ± OADs followed by IDeg OD ± OADs	Active comparator	Drug: insulin degludec, Drug: insulin glargineThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
insulin degludecAdministered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.	Drug	IDeg OD ± OADs followed by IGlar OD ± OADs, IGlar OD ± OADs followed by IDeg OD ± OADs
insulin glargineAdministered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.	Drug	IDeg OD ± OADs followed by IGlar OD ± OADs, IGlar OD ± OADs followed by IDeg OD ± OADs

Primary outcome

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.

5 secondary outcomes

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)
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

Results and safety

Results posted to the registry on 30 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insulin Degludec/Insulin Glargine (IDeg/IGlar)	361	308
Insulin Glargine/Insulin Degludec (IGlar/IDeg)	360	315

Primary outcome: 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). Number. Unit: events

Measure	Insulin Degludec (IDeg) n = 632	Insulin Glargine (IGlar) n = 618
Value	353	496

Insulin Degludec (IDeg) vs Insulin Glargine (IGlar): Treatment ratio: 0.70 (95% CI 0.61 to 0.80), p <0.0001, Poisson

Population analysed: The trial followed a cross over design. Descriptive analysis was based on the safety analysis set (subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for the endpoint as per individual trial products. Statistical analysis was performed on full analysis set

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first day of exposure to randomised treatment and no later than the last day of randomised treatment (64 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Degludec (IDeg)	64 of 671 (9.5%)	93 of 671 (13.9%)	Not reported
Insulin Glargine (IGlar)	65 of 665 (9.8%)	77 of 665 (11.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30705500Chaykin L, Bhargava A, de la Rosa R, Wysham CH, Norgard Troelsen L, Ostoft 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.
Results publication: PubMed 28672317Wysham 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;318(1):45-56. doi: 10.1001/jama.2017.7117.
Results publication: PubMed 30097995Evans 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.
Results publication: PubMed 30362250DeVries 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-treated patients with type 1 and type 2 diabetes: A post hoc analysis of the SWITCH Trials. Diabetes Obes Metab. 2019 Mar;21(3):622-630. doi: 10.1111/dom.13565. Epub 2018 Nov 26.
Results publication: PubMed 30891886Heller 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 Jul;21(7):1634-1641. doi: 10.1111/dom.13708. Epub 2019 Apr 15.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

166 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 166 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02030600, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.