DiabetesPhase 3SWITCH 1NCT02034513

A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes

A Phase 3 study testing insulin degludec, insulin glargine and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 99 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

This trial is conducted in Europe and 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), both with insulin aspart (IAsp) as mealtime insulin in subjects with type 1 diabetes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 1
What is being tested?: insulin degludec, insulin glargine and insulin aspart
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 501 participants
Where: 99 sitesin 3 countries
Study dates: 5 Jan 2014to 11 Jan 2016
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: - Subjects fulfilling at least one of the below criteria: a) Experienced at least one severe hypo episode within the 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) c) Hypoglycaemic symptom unawareness d) Diabetes mellitus duration for more than 15 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) - Male or female, age at least 18 years at the time of signing informed consent - Type 1 diabetes mellitus (diagnosed clinically) for at least 52 weeks prior to Visit 1 - Current treatment with a basal-bolus regimen consisting of neutral protamine Hagedorn (NPH) insulin OD (once daily) / BID (twice daily) or insulin detemir (IDet) OD / BID plus 2-4 daily injections of any rapid acting meal time insulin or CSII (with rapid acting insulin) for at least 26 weeks prior to Visit 1 - HbA1c (glycosylated haemoglobin) below or equal to 10% by central laboratory analysis - BMI (body mass index) below or equal to 45 kg/m^2 Exclusion Criteria: - Treatment with IGlar or IDeg within the last 26 weeks prior to Visit 1 (short term use [less than or equal to 2 weeks] is allowed, but not within 4 weeks prior to screening) - Use of any other anti-diabetic agent than those stated in the inclusion criteria within the last 26 weeks prior to Visit 1

Trial locations and contacts

99 sites in 3 countries.

Country

City, postcode or hospital

99 sites in 3 countries

United States92 sites

Novo Nordisk Investigational Site
Albany, New York, 12206
Novo Nordisk Investigational Site
Amarillo, Texas, 79106
Novo Nordisk Investigational Site
Anderson, Indiana, 46011
Novo Nordisk Investigational Site
Arlington Heights, Illinois, 60005-4144
Novo Nordisk Investigational Site
Asheville, North Carolina, 28803
Novo Nordisk Investigational Site
Austin, Texas, 78731
Novo Nordisk Investigational Site
Austin, Texas, 78758
Novo Nordisk Investigational Site
Billings, Montana, 59101
Novo Nordisk Investigational Site
Birmingham, Alabama, 35215-7502
Novo Nordisk Investigational Site
Carrollton, Texas, 75007
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Chesapeake, Virginia, 23321
Novo Nordisk Investigational Site
Chicago, Illinois, 60611
Novo Nordisk Investigational Site
Concord, California, 94520
Novo Nordisk Investigational Site
Cooper City, Florida, 33024
Novo Nordisk Investigational Site
Council Bluffs, Iowa, 51501
Novo Nordisk Investigational Site
Crystal Lake, Illinois, 60012
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Denver, Colorado, 80220
Novo Nordisk Investigational Site
El Paso, Texas, 79912
Novo Nordisk Investigational Site
Escondido, California, 92025
Novo Nordisk Investigational Site
Federal Way, Washington, 98003
Novo Nordisk Investigational Site
Fleming Island, Florida, 32003
Novo Nordisk Investigational Site
Fort Lauderdale, Florida, 33312
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Goodyear, Arizona, 85395
Novo Nordisk Investigational Site
Greenville, North Carolina, 27834
Novo Nordisk Investigational Site
Hamilton, New Jersey, 08690
Novo Nordisk Investigational Site
Harrison, New York, 10528
Novo Nordisk Investigational Site
Hazelwood, Missouri, 63042
Novo Nordisk Investigational Site
Henderson, Nevada, 89052-2649
Novo Nordisk Investigational Site
Hialeah, Florida, 33012
Novo Nordisk Investigational Site
Houston, Texas, 77024
Novo Nordisk Investigational Site
Houston, Texas, 77079
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46234
Novo Nordisk Investigational Site
Jacksonville, Florida, 32204
Novo Nordisk Investigational Site
Jacksonville, Florida, 32207
Novo Nordisk Investigational Site
Jacksonville, Florida, 32216
Novo Nordisk Investigational Site
Jacksonville, Florida, 32256
Novo Nordisk Investigational Site
Jefferson City, Missouri, 65109
Novo Nordisk Investigational Site
Jenkintown, Pennsylvania, 19046
Novo Nordisk Investigational Site
Kansas City, Missouri, 64106
Novo Nordisk Investigational Site
Katy, Texas, 77450
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
Novo Nordisk Investigational Site
La Jolla, California, 92037
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89148
Novo Nordisk Investigational Site
Lawrenceville, Georgia, 30046
Novo Nordisk Investigational Site
Lenexa, Kansas, 66219
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Livonia, Michigan, 48152
Novo Nordisk Investigational Site
Long Beach, California, 90807
Novo Nordisk Investigational Site
Mesquite, Texas, 75149
Novo Nordisk Investigational Site
Miami, Florida, 33130
Novo Nordisk Investigational Site
Miami, Florida, 33156
Novo Nordisk Investigational Site
Miami, Florida, 33175
Novo Nordisk Investigational Site
Miami Springs, Florida, 33166
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Mineola, New York, 11501
Novo Nordisk Investigational Site
Morehead City, North Carolina, 28557
Novo Nordisk Investigational Site
Nashua, New Hampshire, 03063
Novo Nordisk Investigational Site
New Port Richey, Florida, 34652
Novo Nordisk Investigational Site
Norfolk, Virginia, 23510
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73104
Novo Nordisk Investigational Site
Omaha, Nebraska, 68114
Novo Nordisk Investigational Site
Pembroke Pines, Florida, 33026
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15224-2215
Novo Nordisk Investigational Site
Port Charlotte, Florida, 33952
Novo Nordisk Investigational Site
Port Orange, Florida, 32127
Novo Nordisk Investigational Site
Raleigh, North Carolina, 27609
Novo Nordisk Investigational Site
Rancho Cucamonga, California, 91730-3063
Novo Nordisk Investigational Site
Renton, Washington, 98057
Novo Nordisk Investigational Site
Richardson, Texas, 75080
Novo Nordisk Investigational Site
Richland, Washington, 99352
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84102
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84107
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
San Mateo, California, 94401
Novo Nordisk Investigational Site
San Ramon, California, 94583
Novo Nordisk Investigational Site
Santa Monica, California, 90404
Novo Nordisk Investigational Site
Schertz, Texas, 78154
Novo Nordisk Investigational Site
Skokie, Illinois, 60077
Novo Nordisk Investigational Site
Spokane, Washington, 99208
Novo Nordisk Investigational Site
Sugar Land, Texas, 77478
Novo Nordisk Investigational Site
Syracuse, New York, 13210
Novo Nordisk Investigational Site
Toledo, Ohio, 43614
Novo Nordisk Investigational Site
Topeka, Kansas, 66606
Novo Nordisk Investigational Site
Upland, California, 91786
Novo Nordisk Investigational Site
Ventura, California, 93003
Novo Nordisk Investigational Site
Walla Walla, Washington, 99362-4445
Novo Nordisk Investigational Site
West Des Moines, Iowa, 50265

Other trials in United States

Poland6 sites

Novo Nordisk Investigational Site
Bialystok, 15-435
Novo Nordisk Investigational Site
Gdansk, 80-546
Novo Nordisk Investigational Site
Gdansk, 80-858
Novo Nordisk Investigational Site
Szczecin, 70-506
Novo Nordisk Investigational Site
Warsaw, 04-736
Novo Nordisk Investigational Site
Zabrze, 41-800

Other trials in Poland

Puerto Rico1 site

Novo Nordisk Investigational Site
Manati, 00674

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, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (SWITCH 1)

Conditions: Diabetes, Diabetes Mellitus, Type 1
Being tested: insulin degludec, insulin glargine, insulin aspart
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 1

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.
insulin aspartDrug
Administered 2-4 times daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.

Study groups in NCT02034513
Study group	Role	What they receive
IDeg OD + IAsp followed by IGlar OD + IAsp	Experimental	Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period Receives: Drug: insulin degludec; Drug: insulin glargine; Drug: insulin aspart
IGlar OD + IAsp followed by IDeg OD + IAsp	Active comparator	Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period Receives: Drug: insulin degludec; Drug: insulin glargine; Drug: insulin aspart

What is being measured

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

Number of Treatment Emergent Severe or BG (Blood Glucose) 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 <3.1 mmol/L (56 mg/dL), 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. Maintenance period: 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64).
Measured: A 16-week treatment period.

Secondary outcomes (5)

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes 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 <3.1 mmol/L (56 mg/dL), 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 absolute 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 and Week 64

Timeline

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

5 Jan 201411 Jan 2016

First posted13 Jan 2014 (estimated)
Study start5 Jan 2014
Primary completion11 Jan 2016
Study completion11 Jan 2016

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 (3)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: 501 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02034513
Sponsor's protocol ID: NN1250-3995
Other IDs: U1111-1129-9668, 2012-001930-32
Acronym: SWITCH 1
Status last verified: Dec 2018
First submitted: 7 Jan 2014
Last updated: 2 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lane W, Bailey TS, Gerety G, Gumprecht J, Philis-Tsimikas A, Hansen CT, Nielsen TSS, Warren M; Group Information; SWITCH 1. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial. JAMA. 2017 Jul 4;318(1):33-44. doi: 10.1001/jama.2017.7115.
PubMed 28672316
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

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 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, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (SWITCH 1)
ClinicalTrials.gov ID: NCT02034513
Acronym / sponsor ID: SWITCH 1 / NN1250-3995
Conditions: Diabetes, Diabetes Mellitus, Type 1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 501 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 5 Jan 2014 (actual)
Primary completion: 11 Jan 2016 (actual)
Study completion: 11 Jan 2016 (actual)
First posted: 13 Jan 2014 (estimated)
Results: Posted 15 May 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 + IAsp followed by IGlar OD + IAsp	Experimental	Drug: insulin degludec, Drug: insulin glargine, Drug: insulin aspartEach treatment period consists of a 16-week wash-out period and a 16-week maintenance period
IGlar OD + IAsp followed by IDeg OD + IAsp	Active comparator	Drug: insulin degludec, Drug: insulin glargine, Drug: insulin aspartEach treatment period consists of a 16-week wash-out period and a 16-week maintenance period

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 + IAsp followed by IGlar OD + IAsp, IGlar OD + IAsp followed by IDeg OD + IAsp
insulin glargineAdministered once daily, injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.	Drug	IDeg OD + IAsp followed by IGlar OD + IAsp, IGlar OD + IAsp followed by IDeg OD + IAsp
insulin aspartAdministered 2-4 times daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.	Drug	IDeg OD + IAsp followed by IGlar OD + IAsp, IGlar OD + IAsp followed by IDeg OD + IAsp

Primary outcome

Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period
Time frame: A 16-week treatment 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 <3.1 mmol/L (56 mg/dL), 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. Maintenance period: 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64).

5 secondary outcomes

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes 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 and Week 64

Results and safety

Results posted to the registry on 15 May 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)	249	200
Insulin Glargine/Insulin Degludec (IGlar/IDeg)	252	195

Primary outcome: Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period

Time frame: A 16-week treatment period.. Number. Unit: Event

Measure	Insulin Degludec (IDeg) n = 418	Insulin Glargine (IGlar) n = 422
Value	2772	3126

Insulin Degludec (IDeg) vs Insulin Glargine (IGlar): Treatment ratio: 0.89 (95% CI 0.85 to 0.94), p <0.0001, Poisson

Population analysed: The trial followed a cross over design. Descriptive analysis was based on the safety analysis set (SAS: subjects receiving at least 1 dose of the investigational product, IDeg or its comparator, IGlar). Number of subjects analysed=subjects in the SAS, who were exposed in at least one maintenance period.

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)	58 of 454 (12.8%)	97 of 454 (21.4%)	Not reported
Insulin Glargine (IGlar)	70 of 460 (15.2%)	97 of 460 (21.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28672316Lane W, Bailey TS, Gerety G, Gumprecht J, Philis-Tsimikas A, Hansen CT, Nielsen TSS, Warren M; Group Information; SWITCH 1. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial. JAMA. 2017 Jul 4;318(1):33-44. doi: 10.1001/jama.2017.7115.
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.
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

99 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin degludec, insulin glargine and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 99 sites in 3 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 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Poland, 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 15 May 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 (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period (time frame: A 16-week treatment period.). 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 NCT02034513, which also lists 3 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 2 Jan 2019.