A Phase I Study to Assess the Safety and Efficacy Profile of DCB-DM101 Add-On Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Januvia or Metformin and Jardiance.

VitNovo Australia Pty Ltd0 sites24 target enrollmentJuly 11, 2018

Overview

No summary available.

Registry

who.int

Start Date

July 11, 2018

End Date

March 20, 2019

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

VitNovo Australia Pty Ltd

•1\. Male or female aged between 20\-80 years old;
•2\. Diagnosed with T2DM (WHO 1999 criteria);
•3\. Current treatment for diabetes is not effective in alleviating T2DM after stable treatment with; Januvia (sitagliptin) greater than or equal to 100 mg/day or Jardiance (empagliflozin) greater than or equal to 10 mg/day with metformin greater than or equal to 850 mg/day for at least 3 months. Janumet or Jardiamet will be accepted for this study if the doses of Januvia and Jardiance in combination with metformin are within the above ranges;
•4\. Current treatments for diabetes including Metformin, metformin XR, Januvia or Jardiance must include morning dosing for at least 7 days prior to Visit 2 and until after Visit 3 assessments have been completed;
•5\. HbA1c of \> 6\.5% and \< 12\.0%;
•6\. BMI less than or equal to 45 kg/m2;
•7\. Any other concomitant medications that have been routinely taken should remain at the same dose throughout the study period;
•8\. Participant is willing and able to comply with study procedures and sign informed consent.

•1\. Known or suspected allergy to any ingredients of add\-on study products;
•2\. Pregnant or lactating or premenopausal with childbearing potential but not taking at least two forms of birth control (at least one of which must be a barrier method) during the study;
•3\. Participated in another clinical trial and received an Investigational drug within 12 weeks prior to the present trial;
•4\. Impaired hepatic function defined as alanine aminotransferase (ALT), aspartate transaminase (AST) or alkaline phosphatase (ALP) at least 2\.5 times upper referenced limit;
•5\. Impaired renal function defined as serum\-creatinine at least 1\.3 mg/dL (at least
•115 µmol/L) for males and at least 1\.2 mg/dL (at least 106 µmol/L) for females;
•6\. With any uncontrolled illness or a history of any illness, e.g. hyperthyroidism, judged by the Investigator that entering the trial may be detrimental to the participant;
•7\. Metformin, Januvia and/or Jardiance contraindications according to the product information;
•8\. Taking any antidiabetic medication other than the combination within the allocated treatment arm (metformin, Januvia, Jardiance, Janumet or Jardiamet). Participants taking other proprietary DPP4 or SGLT2 inhibitors will be excluded from this study;
•9\. Current treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents;