Are You Currently Taking Basal (Long-Acting) Insulin to Treat Your Type 2 Diabetes?

  • STATUS
    Recruiting
Updated on 27 January 2021
diabetes
diabetes mellitus
type 2 diabetes mellitus
type 2 diabetes
diabetes mellitus (dm)
diabetes type 2

Summary

We are currently seeking volunteers who are diagnosed with Type 2 Diabetes and who are treating with Basal Insulin, with or without up to 2 other oral diabetes medications for the past 3 months:

  • Once or Twice Daily: NPH, Lantus or Basaglar (U100 or U300), Levemir, Tresiba (U100 or U200).
  • With or without up to 2 of the following:
    • Stable dose Metformin ³ 1500mg QD
    • SUs: Glimepiride, Glipizide, Glyburide
    • DPP-4’s: Januvia, Onglyza, Tradjenta, Nesina

This is a study of an investigational once weekly injectable medication that may help to improve blood sugar levels and help lose weight. All participants will switch to taking Lantus (Glargine-U100) insulin, and will be assigned to one of four groups: three of every four of the participants will add on the investigational once weekly injectable medication, and one of every four will add on (FDA Approved) Daily Insulin Humalog (Lispro-U100) to be administered three times a day.

Participants taking Metformin can continue taking their Metformin. Participants must be willing to keep a paper glucose diary and be willing to perform ten 7-point glucose profiles during the study (10 times during the study where you check your blood sugars at 7 specific time points.) Participants will also receive a dilated Fundoscopic exam to test for retinopathy and macular edema.

For further information, please click here: https://rainier-research.com/studies/are-you-currently-taking-basal-long-acting-insulin-to-treat-your-type-2-diabetes/

Description

Study Length: 68 weeks, with 16 clinic visits and 8 telephone appointments.

Target Age: 18+ years old.

Benefits: Participants will receive the following at no cost: Lantus insulin, study medication or Humalog insulin, study related: physical exams, EKG’s, lab work; a glucose meter, test strips and other supplies.

Stipend: $4775 for study completion.

Details
Condition Diabetes Mellitus, Type 2, Diabetes Mellitus Type 2
Clinical Study IdentifierTX264360
Last Modified on27 January 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?
Must be diagnosed with type 2 diabetes
Must be treating with Basal insulin
Must NOT be treating with bolus/meal-time insulin
Must have an HbA1c between 7.5 - 11.0%
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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