NCT03687827|CompletedPhase 4ResultsFDA Drug

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

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

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN1250-4419U1111-1203-05802017-004047-20

Study Type

interventional

Target

498

Locations

6 countries

Sites

Timeline

RegisteredSep 2018

StartedOct 2018

CompletionDec 2019

Brief 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. 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

498

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Timeline

Completed

Started Oct 2018

Geographic Reach

6 countries

67 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

September 21, 2018

Completed

6 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed

5 days until next milestone

Study Start

First participant enrolled

October 2, 2018

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed

7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2019

Completed

1 year until next milestone

Results Posted

Study results publicly available

January 12, 2021

Completed

Last Updated

January 12, 2021

Status Verified

December 1, 2020

Enrollment Period

1.2 years

First QC Date

September 21, 2018

Results QC Date

December 16, 2020

Last Update Submit

December 16, 2020

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

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

Secondary Outcomes (5)

Time Spent in Tight Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, Using Flash Glucose Monitoring
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
During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
Level of Glycated Haemoglobin (HbA1c) - Percentage
After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).
Level of Glycated Haemoglobin (HbA1c) - mmol/Mol
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)
During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

Study Arms (2)

Insulin degludec

EXPERIMENTAL

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

Drug: Insulin degludec

Insulin glargine

ACTIVE COMPARATOR

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

Drug: Insulin glargine

Interventions

Insulin degludecDRUG

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.

Also known as: Tresiba®

Insulin degludec

Insulin glargineDRUG

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.

Also known as: Lantus®

Insulin glargine

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
+2 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.