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 (SWITCH PRO)

December 16, 2020 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

498

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2H 2G4
        • Novo Nordisk Investigational Site
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 4A1
        • Novo Nordisk Investigational Site
    • Ontario
      • Concord, Ontario, Canada, L4K 4M2
        • Novo Nordisk Investigational Site
      • Etobicoke, Ontario, Canada, M9R 4E1
        • Novo Nordisk Investigational Site
      • London, Ontario, Canada, N5W 6A2
        • Novo Nordisk Investigational Site
      • Markham, Ontario, Canada, L3P 7P2
        • Novo Nordisk Investigational Site
      • Oakville, Ontario, Canada, L6M 1M1
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M6G 1M2
        • Novo Nordisk Investigational Site
      • Toronto, Ontario, Canada, M4G 3E8
        • Novo Nordisk Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 2C6
        • Novo Nordisk Investigational Site
  • Poland
      • Bialystok, Poland, 15-351
        • Novo Nordisk Investigational Site
      • Bialystok, Poland, 15-404
        • Novo Nordisk Investigational Site
      • Gdansk, Poland, 80-858
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-538
        • Novo Nordisk Investigational Site
      • Warsaw, Poland, 00-465
        • Novo Nordisk Investigational Site
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Novo Nordisk Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 851 01
        • Novo Nordisk Investigational Site
      • Bratislava, Slovakia, 831 01
        • Novo Nordisk Investigational Site
      • Bytca, Slovakia, 014 01
        • Novo Nordisk Investigational Site
      • Levice, Slovakia, 93401
        • Novo Nordisk Investigational Site
      • Malacky, Slovakia, 901 01
        • Novo Nordisk Investigational Site
      • Nove Mesto nad Vahom, Slovakia, 915 01
        • Novo Nordisk Investigational Site
      • Nove Zamky, Slovakia, 940 59
        • Novo Nordisk Investigational Site
      • Trebisov, Slovakia, 07501
        • Novo Nordisk Investigational Site
      • Trnava, Slovakia, 91701
        • Novo Nordisk Investigational Site
      • Zilina, Slovakia, 010 01
        • Novo Nordisk Investigational Site
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6045
        • Novo Nordisk Investigational Site
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1829
        • Novo Nordisk Investigational Site
      • Johannesburg, Gauteng, South Africa, 1827
        • Novo Nordisk Investigational Site
      • Lenasia, Gauteng, South Africa, 1827
        • Novo Nordisk Investigational Site
      • Pretoria, Gauteng, South Africa, 0044
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7130
        • Novo Nordisk Investigational Site
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Novo Nordisk Investigational Site
      • Tucson, Arizona, United States, 85741
        • Novo Nordisk Investigational Site
    • California
      • Fresno, California, United States, 93720
        • Novo Nordisk Investigational Site
      • Lancaster, California, United States, 93534
        • Novo Nordisk Investigational Site
      • Northridge, California, United States, 91325
        • Novo Nordisk Investigational Site
      • Poway, California, United States, 92064
        • Novo Nordisk Investigational Site
      • Van Nuys, California, United States, 91405
        • Novo Nordisk Investigational Site
    • Connecticut
      • Hamden, Connecticut, United States, 06517
        • Novo Nordisk Investigational Site
    • Florida
      • Bradenton, Florida, United States, 34201
        • Novo Nordisk Investigational Site
      • Cooper City, Florida, United States, 33024
        • Novo Nordisk Investigational Site
      • Hollywood, Florida, United States, 33024
        • Novo Nordisk Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Novo Nordisk Investigational Site
      • Orlando, Florida, United States, 32825
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33027
        • Novo Nordisk Investigational Site
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Novo Nordisk Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novo Nordisk Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Novo Nordisk Investigational Site
      • Louisville, Kentucky, United States, 40213
        • Novo Nordisk Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115-5804
        • Novo Nordisk Investigational Site
      • Boston, Massachusetts, United States, 02118
        • Novo Nordisk Investigational Site
    • Montana
      • Kalispell, Montana, United States, 59901
        • Novo Nordisk Investigational Site
    • New York
      • New Windsor, New York, United States, 12553
        • Novo Nordisk Investigational Site
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Novo Nordisk Investigational Site
      • Statesville, North Carolina, United States, 28625
        • Novo Nordisk Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Novo Nordisk Investigational Site
      • Toledo, Ohio, United States, 43614
        • Novo Nordisk Investigational Site
    • South Carolina
      • Pelzer, South Carolina, United States, 29669
        • Novo Nordisk Investigational Site
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Novo Nordisk Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Novo Nordisk Investigational Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Novo Nordisk Investigational Site
      • Kerrville, Texas, United States, 78028
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78215
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78224
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78228-6205
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin degludec
Participants will receive insulin degludec in period 1 and 2 in a cross-over manner.
Drug: 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.
Other Names:
  • Tresiba®
Active Comparator: Insulin glargine
Participants will receive insulin glargine in period 1 and 2 in a cross-over manner.
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.
Other Names:
  • Lantus®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Spent in Tight Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, Using Flash Glucose Monitoring
Time Frame: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
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)).
During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-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
Time Frame: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
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)).
During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
Level of Glycated Haemoglobin (HbA1c) - Percentage
Time Frame: After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
Level of HbA1c after two weeks of maintenance periods (Visit 19-21 (week 16-17) and Visit 37-39 (week 34-35)).
After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
Level of Glycated Haemoglobin (HbA1c) - mmol/Mol
Time Frame: After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
Level of HbA1c after two weeks of maintenance periods (Visit 19-21 (week 16-17) and Visit 37-39 (week 34-35)).
After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
Mean Glucose Levels Using Flash Glucose Monitoring (FGM)
Time Frame: During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
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)).
During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2018

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

December 27, 2019

Study Registration Dates

First Submitted

September 21, 2018

First Submitted That Met QC Criteria

September 21, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1250-4419
  • U1111-1203-0580 (Other Identifier: World Health Organization (WHO))
  • 2017-004047-20 (Registry Identifier: European Medicines Agency (EudraCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Insulin degludec

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe