Do You Take Two Insulins to Treat Your Type 2 Diabetes?

  • STATUS
    Recruiting
Updated on 26 February 2021

Summary

We are currently seeking volunteers who are diagnosed with Type 2 Diabetes and who are treating with a Basal/Bolus insulin regimen.
(Participants can also be treating with up to 3 other oral diabetes medications. They can also be taking injectable GLP-1 medications and qualify. Medications need to be stable for 90 days.)

Qualifying Insulins:
  • Basal insulin: Lantus or Basaglar (Glargine)
  • Bolus insulin: Humalog (Lispro), Novolog (Aspart), or Apidra (Glulisine).
  • With or without up to 3 of the following:
    • Metformin
    • Januvia, Onglyza, Tradjenta, or Nesina. (DPP-4’s)
    • Farxiga, Invokana, or Jardiance. (SGLT2’s)
    • Rybelsus (Oral GLP-1)
  • Participants may also be currently taking injectable GLP-1s: Byetta, Bydureon, Victoza, Tanzeum, Trulicity, or Ozempic.
This is a study of an investigational injectable meal-time insulin that may help to better regulate blood sugar levels through the use of a Continuous Glucose Monitoring (CGM) System. All participants will continue or start taking Basaglar insulin (glargine-U100). All participants will also start taking the investigational meal-time insulin 3 times a day (before breakfast, lunch, and dinner). Participants may continue the use of their current stable OAMs or injectable GLP-1s throughout the study.

Description

Study Length: 19 weeks, with 6 clinic visits and 7 telephone appointments.

Target Age: 18+ years old.

Benefits: Participants will receive the following at no cost: All of their insulin (Basaglar and study medication [bolus insulin]), study related physical exams, EKGs, lab work, use of the Freestyle Libre CGM, a glucose meter, test strips and other supplies.

Stipend: $625 for study completion ($75 per clinic visit and $25 per telephone visit.)

Details
Condition Diabetes Mellitus, Type 2, Diabetes Mellitus Type 2
Clinical Study IdentifierTX267207
Last Modified on26 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Diabetes Mellitus Type 2 or Diabetes Mellitus, Type 2?
Do you have any of these conditions: Diabetes Mellitus, Type 2 or Diabetes Mellitus Type 2?
Must have a Type 2 Diabetes diagnosis for at least 1 year
Must be treating with basal (long acting) and bolus (short acting) insulin
Must have an HbA1c between 7.5-10.0% at screening
Must have a BMI ≤ 40
Must meet other eligibility criteria. Please contact us for further details
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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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