FABULINUS Study

Currently recruiting

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A 52-week randomised, double-blind, placebo controlled, multi-centre study assessing safety and efficacy of Investigational study drug for preservation of pancreatic beta-cell function in adults and adolescents with newly diagnosed type 1 diabetes on insulin therapy.

Recruiting sites:

  • Cambridge University Hospital
  • Leicester General Hospital
  • Northwick Park Hospital
  • Birmingham Children’s Hospital
  • Tayside Children’s Hospital, Dundee
  • Glasgow, Clinical Research Facility, Institute of Neurological Sciences

Summary

This study is for people 12 to 21 years of age with Type 1 Diabetes. Researchers want to know if different doses of a new medicine Investigational study drug can protect remaining beta cells from being destroyed and improve body’s control of blood glucose (sugar) levels.

The study contains 2 parts:

  • Part A: adults (18-35 years old) take Investigational study drug Dose 3 or placebo for 2 years. (Part A now completed).
  • Part B: adolescents and young adults (12-21 years old) take one of 3 Investigational study drug doses (Dose 1, 2 or 3) or a placebo for 2 years.

Eligibility to take part

  1. People recently diagnosed with T1D
  2. Who are taking insulin therapy for 90 days or less
  3. Who are 12-21 years of age

If you are interested in taking part, please click the “Get Involved” button below:

Get Involved

What will I be asked to do?

If you decide to take part in this study, you will get Investigational study drug or a placebo on top of your usual insulin treatment for up to 104 weeks. You will receive Investigational study drug (or placebo) through a drip into a vein (called infusion) in your arm at Day 1 (it will last around 1 hour) and then injection under the skin (subcutaneous) with a syringe every 2 weeks at the study site, or by a nurse visiting your home or you will be allowed to self-administer after study site visit Week 6, provided that you have been appropriately trained.

After you sign the Informed Consent Form, testing will be done to determine if you are eligible to participate in this study. You must meet certain requirements to be able to participate in this study.

Who is running this study?

This study is being run by Sanofi UK. It is funded by Sanofi-Aventis Research and Development

Sponsor: Sanofi-Aventis Research & Development, France

Chief Investigator: Dr Pratik Choudhary, Leicester General Hospital, Gwendolen Road, Leicester, LE5 4PW

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