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Diabetes Mellitus, Type 2Phase 4SWITCH PRONCT03687827

A Research Study to Compare the Effect of Insulin Degludec and Insulin Glargine on Blood Sugar Levels in People With Type 2 Diabetes - the SWITCH PRO Study

A Phase 4 study testing Insulin degludec and Insulin glargine in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 67 sites in 6 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 study compares the effect on blood sugar levels of two medicines: insulin degludec and insulin glargine in people with type 2 diabetes. Participants will be treated with insulin degludec and insulin glargine during two different periods. Which treatment participants get first is decided by chance. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin degludec and Insulin glargine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
498 participants
Where
67 sitesin 6 countries
Study dates
2 Oct 2018to 27 Dec 2019
Phase
Phase 4
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

Who may be able to join

  • Male or female, age greater than or equal to 18 years at the time of signing informed consent
  • Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening
  • Subjects fulfilling at least one of the below criteria:
  • Experienced at least one severe hypoglycaemic episode within the last year prior to screening (according to the American Diabetes Association definition, January 2018)*
  • Moderate renal impairment defined as estimated glomerular filtration rate value of 30-59 mL/min/1.73 m^2 as defined by Kidney Disease Improving Global Outcomes 2012 at screening
  • Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8 at screening
Show all 17Show fewer
  • Treated with insulin for more than 5 years
  • Episode of hypoglycaemia (defined a glucose alert value of 70 mg/dL (3.9 mmol/L) or less, i.e., Level 1) within the last 12 weeks prior to screening visit
  • Treated with any basal insulin greater than or equal to 90 days prior to the day of screening with or without any of the following anti-diabetic drugs:
  • Metformin
  • Dipeptidyl peptidase-4 inhibitor
  • Sodium-glucose co-transporter 2 inhibitor
  • Alpha-glucosidase-inhibitors (acarbose)
  • Thiazolidinediones
  • Marketed oral combination products only including the products listed above
  • HbA1c less than or equal to 9.5% (80 mmol/mol) at screening confirmed by central laboratory analysis
  • Body mass index less than or equal to 45 kg/m^2 *Hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery

Who cannot join

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, intermittent bolus insulin treatment for periods of no longer than 14 days are permitted prior to the day of screening
  • Anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids)
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and run-in

Trial locations and contacts

67 sites in 6 countries.

67 sites in 6 countries

United States34 sites

  • Novo Nordisk Investigational Site

    Amarillo, Texas, 79106

  • Novo Nordisk Investigational Site

    Boston, Massachusetts, 02115-5804

  • Novo Nordisk Investigational Site

    Boston, Massachusetts, 02118

  • Novo Nordisk Investigational Site

    Bradenton, Florida, 34201

  • Novo Nordisk Investigational Site

    Chandler, Arizona, 85224

  • Novo Nordisk Investigational Site

    Cincinnati, Ohio, 45245

  • Novo Nordisk Investigational Site

    Cooper City, Florida, 33024

  • Novo Nordisk Investigational Site

    Dakota Dunes, South Dakota, 57049

  • Novo Nordisk Investigational Site

    Fresno, California, 93720

  • Novo Nordisk Investigational Site

    Greenville, North Carolina, 27834

  • Novo Nordisk Investigational Site

    Hamden, Connecticut, 06517

  • Novo Nordisk Investigational Site

    Hollywood, Florida, 33024

  • Novo Nordisk Investigational Site

    Kalispell, Montana, 59901

  • Novo Nordisk Investigational Site

    Kerrville, Texas, 78028

  • Novo Nordisk Investigational Site

    Lancaster, California, 93534

  • Novo Nordisk Investigational Site

    Lexington, Kentucky, 40503

  • Novo Nordisk Investigational Site

    Louisville, Kentucky, 40213

  • Novo Nordisk Investigational Site

    Nashville, Tennessee, 37203

  • Novo Nordisk Investigational Site

    New Port Richey, Florida, 34652

  • Novo Nordisk Investigational Site

    New Windsor, New York, 12553

  • Novo Nordisk Investigational Site

    Northridge, California, 91325

  • Novo Nordisk Investigational Site

    Orlando, Florida, 32825

  • Novo Nordisk Investigational Site

    Pelzer, South Carolina, 29669

  • Novo Nordisk Investigational Site

    Pembroke Pines, Florida, 33027

  • Novo Nordisk Investigational Site

    Poway, California, 92064

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78215

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78224

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78228-6205

  • Novo Nordisk Investigational Site

    Skokie, Illinois, 60077

  • Novo Nordisk Investigational Site

    Statesville, North Carolina, 28625

  • Novo Nordisk Investigational Site

    Toledo, Ohio, 43614

  • Novo Nordisk Investigational Site

    Topeka, Kansas, 66606

  • Novo Nordisk Investigational Site

    Tucson, Arizona, 85741

  • Novo Nordisk Investigational Site

    Van Nuys, California, 91405

Other trials in United States

Canada10 sites

  • Novo Nordisk Investigational Site

    Calgary, Alberta, T2H 2G4

  • Novo Nordisk Investigational Site

    Concord, Ontario, L4K 4M2

  • Novo Nordisk Investigational Site

    Etobicoke, Ontario, M9R 4E1

  • Novo Nordisk Investigational Site

    London, Ontario, N5W 6A2

  • Novo Nordisk Investigational Site

    Markham, Ontario, L3P 7P2

  • Novo Nordisk Investigational Site

    Montreal, Quebec, H4A 2C6

  • Novo Nordisk Investigational Site

    Oakville, Ontario, L6M 1M1

  • Novo Nordisk Investigational Site

    Toronto, Ontario, M4G 3E8

  • Novo Nordisk Investigational Site

    Toronto, Ontario, M6G 1M2

  • Novo Nordisk Investigational Site

    Victoria, British Columbia, V8V 4A1

Other trials in Canada

Slovakia10 sites

  • Novo Nordisk Investigational Site

    Bratislava, 831 01

  • Novo Nordisk Investigational Site

    Bratislava, 851 01

  • Novo Nordisk Investigational Site

    Bytča, 014 01

  • Novo Nordisk Investigational Site

    Levice, 93401

  • Novo Nordisk Investigational Site

    Malacky, 901 01

  • Novo Nordisk Investigational Site

    Nové Mesto nad Váhom, 915 01

  • Novo Nordisk Investigational Site

    Nové Zámky, 940 59

  • Novo Nordisk Investigational Site

    Trebišov, 07501

  • Novo Nordisk Investigational Site

    Trnava, 91701

  • Novo Nordisk Investigational Site

    Žilina, 010 01

Other trials in Slovakia

South Africa7 sites

  • Novo Nordisk Investigational Site

    Bloemfontein, Free State, 9301

  • Novo Nordisk Investigational Site

    Cape Town, Western Cape, 7130

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 1827

  • Novo Nordisk Investigational Site

    Johannesburg, Gauteng, 1829

  • Novo Nordisk Investigational Site

    Lenasia, Gauteng, 1827

  • Novo Nordisk Investigational Site

    Port Elizabeth, Eastern Cape, 6045

  • Novo Nordisk Investigational Site

    Pretoria, Gauteng, 0044

Other trials in South Africa

Poland5 sites

  • Novo Nordisk Investigational Site

    Bialystok, 15-351

  • Novo Nordisk Investigational Site

    Bialystok, 15-404

  • Novo Nordisk Investigational Site

    Gdansk, 80-858

  • Novo Nordisk Investigational Site

    Lublin, 20-538

  • Novo Nordisk Investigational Site

    Warsaw, 00-465

Other trials in Poland

Puerto Rico1 site

  • Novo Nordisk Investigational Site

    Ponce, 00716

Other trials in Puerto Rico

About this study

Official title: A Randomised, Cross-over, Open-label, Multi-centre Trial Comparing the Effect of Insulin Degludec and Insulin Glargine 100U/mL, With or Without OADs in Subjects With Type 2 Diabetes Using Flash Glucose Monitoring

This study compares the effect on blood sugar levels of two medicines: insulin degludec and insulin glargine in people with type 2 diabetes. Participants will be treated with insulin degludec and insulin glargine during two different periods. Which treatment participants get first is decided by chance. Both medicines are approved for use in humans and available on the market. They can already be prescribed by participants' doctors. Participants will get pre-filled insulin pens to inject these insulins with. The study will last for about 41 weeks. Participants will visit the clinic 13 times and have 27 phone calls with the study doctor or study staff. At 12 of the clinic visits they will take blood samples. In order to evaluate the changes in participants' blood sugar level over time, participants will be asked to wear a small (35 millimetres (mm) x 5 mm) sensor on the back of participants' upper arm 3 times during the study. Each time participants must wear the sensor for 2 weeks. This sensor is called FreeStyle Libre Pro®. It has a very small tip which is 0.4 mm thick and is inserted 5 mm under participants' skin. Please note that participants will not be able to see the sensor readings while wearing it. The study doctor will show participants the readings when participants return to the clinic. Participants will be asked to fill in a diary in between visits. Participants will have contact with the study doctor or study staff each week. This is to adjust the dose of participants' study medicines and to ensure that participants are well. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Being tested
Insulin degludec, Insulin glargine
Medical subject headings
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

    Also called Tresiba®

    Participants will receive insulin degludec U100 subcutaneous (s.c.) injection once daily for 36 weeks. Doses will be adjusted according to the fasting self-measured plasma glucose (SMPG) values. Participants earlier treated with one or more allowed oral antidiabetic drug(s) (OAD(s)), should continue their pre-trial OAD(s) treatment throughout the trial.

  • Insulin glargineDrug

    Also called Lantus®

    Participants will receive insulin glargine U100 s.c. injection once daily for 36 weeks. Doses will be adjusted according to the fasting SMPG values. Participants earlier treated with one or more allowed OAD(s), should continue their pre-trial OAD(s) treatment throughout the trial.

Study groups in NCT03687827
Study groupRoleWhat they receive
Insulin degludecExperimentalParticipants will receive insulin degludec in period 1 and 2 in a cross-over manner.
Receives: Drug: Insulin degludec
Insulin glargineActive comparatorParticipants will receive insulin glargine in period 1 and 2 in a cross-over manner.
Receives: Drug: Insulin glargine

What is being measured

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

  1. Percentage of Time Spent in Glycaemic Target Range 70-180 mg/dL (3.9-10.0 mmol/L) Both Inclusive, Using Flash Glucose Monitoring (FGM)

    The percentage of time spent in glycaemic target range was calculated as the number of recorded measurements in glycaemic target range (70-180 milligrams per deciliter [mg/dL] (3.9-10.0 millimoles per litre [mmol/L]), both inclusive) divided by the total number of recorded measurements. The endpoint is based on data recorded by FGM system. It was required that at least 70% of the planned FGM measurements during weeks 16-17 and weeks 34-35 were available for endpoint data to be included in the analysis.

    Measured: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2)

Secondary outcomes (5)

  1. Time Spent in Tight Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, Using Flash Glucose Monitoring

    The percentage of time spent in tight glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, during the 2-week maintenance periods using FGM (visit 9-21 (week 16-17) and visit 37-39 (week 34-35)).

    Measured: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

  2. Time Spent in Nocturnal Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, in the Nocturnal Period (00:01 am - 05:59 am Both Inclusive) Using Flash Glucose Monitoring

    Percentage of time spent in nocturnal glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, in the nocturnal period (00:01 am - 05:59 am both inclusive) during the 2-week maintenance periods using FGM (visit 19-21 (week 16-17) and visit 37-39 (week 34-35)).

    Measured: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

  3. Level of Glycated Haemoglobin (HbA1c) - Percentage

    Level of HbA1c after two weeks of maintenance periods (Visit 19-21 (week 16-17) and Visit 37-39 (week 34-35)).

    Measured: After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

  4. Level of Glycated Haemoglobin (HbA1c) - mmol/Mol

    Level of HbA1c after two weeks of maintenance periods (Visit 19-21 (week 16-17) and Visit 37-39 (week 34-35)).

    Measured: After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

  5. Mean Glucose Levels Using Flash Glucose Monitoring (FGM)

    Mean glucose levels (mmol/L) during the 2-week maintenance periods using FGM (visit 19-21 (week 16-17) and visit 37-39 (week 34-35)).

    Measured: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

Timeline

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

  1. First posted27 Sep 2018
  2. Study start2 Oct 2018
  3. Primary completion20 Dec 2019
  4. Study completion27 Dec 2019

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
498 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03687827
Sponsor's protocol ID
NN1250-4419
Other IDs
U1111-1203-0580, 2017-004047-20, 2017
Acronym
SWITCH PRO
Status last verified
Dec 2020
First submitted
21 Sep 2018
Last updated
12 Jan 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Goldenberg RM, Aroda VR, Billings LK, Donatsky AM, Frederiksen M, Klonoff DC, Kalyanam B, Bergenstal RM. Correlation Between Time in Range and HbA1c in People with Type 2 Diabetes on Basal Insulin: Post Hoc Analysis of the SWITCH PRO Study. Diabetes Ther. 2023 May;14(5):915-924. doi: 10.1007/s13300-023-01389-2. Epub 2023 Mar 11.

    PubMed 36905485

  • Goldenberg RM, Aroda VR, Billings LK, Christiansen ASL, Meller Donatsky A, Parvaresh Rizi E, Podgorski G, Raslova K, Klonoff DC, Bergenstal RM. Effect of insulin degludec versus insulin glargine U100 on time in range: SWITCH PRO, a crossover study of basal insulin-treated adults with type 2 diabetes and risk factors for hypoglycaemia. Diabetes Obes Metab. 2021 Nov;23(11):2572-2581. doi: 10.1111/dom.14504. Epub 2021 Aug 16.

    PubMed 34322967

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin degludec and Insulin glargine in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 67 sites in 6 countries.

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

Who may be eligible to take part?

The sponsor lists 17 inclusion and 3 exclusion criteria. 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 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Canada, Slovakia, South Africa, Poland and 1 more country. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 12 Jan 2021). 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?

Percentage of Time Spent in Glycaemic Target Range 70-180 mg/dL (3.9-10.0 mmol/L) Both Inclusive, Using Flash Glucose Monitoring (FGM) (time frame: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2)). 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 NCT03687827, which also lists 2 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 12 Jan 2021.

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