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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

NCT ID: NCT03687827

Last Updated: 2021-01-12

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

498 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-02

Study Completion Date

2019-12-27

Brief Summary

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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.

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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

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin degludec

Participants will receive insulin degludec in period 1 and 2 in a cross-over manner.

Group Type EXPERIMENTAL

Insulin degludec

Intervention Type DRUG

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 glargine

Participants will receive insulin glargine in period 1 and 2 in a cross-over manner.

Group Type ACTIVE_COMPARATOR

Insulin glargine

Intervention Type DRUG

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.

Interventions

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Insulin degludec

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.

Intervention Type DRUG

Insulin glargine

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.

Intervention Type DRUG

Other Intervention Names

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Tresiba® Lantus®

Eligibility Criteria

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Inclusion Criteria

* 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
* 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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Chandler, Arizona, United States

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Tucson, Arizona, United States

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Fresno, California, United States

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Lancaster, California, United States

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Northridge, California, United States

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Poway, California, United States

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Van Nuys, California, United States

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Hamden, Connecticut, United States

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Bradenton, Florida, United States

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Cooper City, Florida, United States

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Hollywood, Florida, United States

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New Port Richey, Florida, United States

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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

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Skokie, Illinois, United States

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Topeka, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Kalispell, Montana, United States

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New Windsor, New York, United States

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Greenville, North Carolina, United States

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Statesville, North Carolina, United States

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Cincinnati, Ohio, United States

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Toledo, Ohio, United States

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Pelzer, South Carolina, United States

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Dakota Dunes, South Dakota, United States

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Nashville, Tennessee, United States

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Amarillo, Texas, United States

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Kerrville, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Calgary, Alberta, Canada

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Victoria, British Columbia, Canada

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Concord, Ontario, Canada

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Etobicoke, Ontario, Canada

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London, Ontario, Canada

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Markham, Ontario, Canada

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Oakville, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Bialystok, , Poland

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Gdansk, , Poland

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Lublin, , Poland

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Warsaw, , Poland

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Ponce, , Puerto Rico

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bytča, , Slovakia

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Levice, , Slovakia

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Malacky, , Slovakia

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Nové Mesto nad Váhom, , Slovakia

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Nové Zámky, , Slovakia

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Trebišov, , Slovakia

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Trnava, , Slovakia

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Žilina, , Slovakia

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Port Elizabeth, Eastern Cape, South Africa

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Bloemfontein, Free State, South Africa

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Johannesburg, Gauteng, South Africa

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Johannesburg, Gauteng, South Africa

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Lenasia, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Cape Town, Western Cape, South Africa

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Countries

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United States Canada Poland Puerto Rico Slovakia South Africa

References

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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.

Reference Type DERIVED
PMID: 36905485 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34322967 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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U1111-1203-0580

Identifier Type: OTHER

Identifier Source: secondary_id

2017-004047-20

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN1250-4419

Identifier Type: -

Identifier Source: org_study_id

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