The INSTRIDE 1 Study is looking to see how well an investigational insulin works to control blood sugar levels in patients with Type 1 Diabetes.

  • STATUS
    Recruiting
  • sponsor
    Mylan GmbH
Updated on 23 November 2020

Summary

The INSTRIDE 1 Study is looking to see how well an investigational insulin works to control blood sugar levels in patients with Type 1 Diabetes.

Description

The investigational medication is a potential new type of insulin that is similar to insulin glargine (Lantus®), which you are currently taking. If the investigational medication is approved, it could be a more affordable treatment option, becoming more widely available and benefiting more people with diabetes worldwide. The aim of this study is to see how well the investigational medication works compared with Lantus®. We are looking for about 500 people with Type 1 Diabetes across several countries to take part in the INSTRIDE 1 Study. The maximum length of the study is 66 weeks (just over 1 year). During this time, you will need to visit the study center 22 times (although some visits may be conducted by telephone rather than at the study center) and undergo a number of tests and assessments, including blood tests, checking your vital signs (e.g. heart rate and blood pressure), and physical examinations.

If you decide you would like to take part in the INSTRIDE 1 Study, the study doctor will first do some health checks to make sure that the study is right for you. If you can take part, you will receive either the investigational medication or Lantus® at no charge for the duration of the study. You will also be given an approved short-acting insulin to be used at mealtimes. If you want to find out more about the INSTRIDE 1 Study, please contact the study team using the details below.

Email: info@hansoncrc.com
Tel:941-764-9110

Details
Condition Diabetes Mellitus, Type 1
Clinical Study IdentifierTX140043
SponsorMylan GmbH
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

You may be able to take part in this study if you
are between 18 and 65 years of age
have been diagnosed with Type 1 Diabetes
have been taking Lantus® (insulin glargine) for at least 3 months
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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