A Double-Blinded, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Diet Control Alone or on Diet Control and Metformin Monotherapy

  • STATUS
    Recruiting
  • End date
    Jul 6, 2023
  • sponsor
    Oramed Ltd
Updated on 13 September 2022

Summary

Do you have Type II Diabetes? Do you often feel like your glucose levels are all over the place? Would you want to be involved in a clinical study to improve the treatment options for Type II Diabetes? This research study is evaluating a novel investigational drug to treat Type II Diabetes. This investigational oral drug will provide a more convenient and efficient alternative to inhaled or injectable insulin for the treatment of Type II Diabetes. Qualified participants may be compensated for their time and travel. 

Description

Study consists of approximately 13 office visits over 57 weeks. 

Details
Condition Diabetes Mellitus Type 2
Clinical Study IdentifierTX306125
SponsorOramed Ltd
Last Modified on13 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Medically diagnosed with DMT2
Current Therapy is only taking Metformin and/or Controlled Diet
A1c value must be between 7% - 9%

Exclusion Criteria

Taking any other DMT2 Medication besides Metformin
BMI >40 kg
History of Bariatric Surgery
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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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