DCB-DM101 in Participants with Type 2 Diabetes Mellitus
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 Ltd
24 participants
Jul 16, 2018
Interventional
Conditions
Summary
Type 2 diabetes mellitus (T2DM) is a progressive multisystem disease. Despite the large amount of oral antidiabetic agents available, current therapy is not optimal. More than 60% of people with T2DM have inadequately controlled glucose levels. DCB-DM101 is a new botanical investigational drug which has been developed by Development Centre for Biotechnology (DCB) in Taiwan. DCB-DM101 is hoped to offer an alternate approach to the management of many aspects of T2DM. The aim of this Phase I study is to assess the safety and efficacy profile of DCB-DM101 (the "study drug") when given in combination with existing antidiabetic treatments (metformin and Januvia (sitagliptin) or metformin and Jardiance (empagliflozin)) to participants who have inadequately controlled T2DM. Two groups of participants will be recruited and take a daily oral dose of DCB-DM101 (330 mg/day) for 7 consecutive days in addition to their standard antidiabetic treatment (metformin and sitagliptin or metformin and empagliflozin). A third comparative group of participants will be administered empagliflozin (instead of DCB-DM101) in addition to their standard antidiabetic treatment of metformin and sitagliptin.
Eligibility
Inclusion Criteria8
- Male or female aged between 20-80 years old;
- Diagnosed with T2DM (WHO 1999 criteria);
- 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;
- 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;
- HbA1c of > 6.5% and < 12.0%;
- BMI less than or equal to 45 kg/m2;
- Any other concomitant medications that have been routinely taken should remain at the same dose throughout the study period;
- Participant is willing and able to comply with study procedures and sign informed consent.
Exclusion Criteria14
- Known or suspected allergy to any ingredients of add-on study products;
- 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;
- Participated in another clinical trial and received an Investigational drug within 12 weeks prior to the present trial;
- Impaired hepatic function defined as alanine aminotransferase (ALT), aspartate transaminase (AST) or alkaline phosphatase (ALP) at least 2.5 times upper referenced limit;
- Impaired renal function defined as serum-creatinine at least 1.3 mg/dL (at least
- µmol/L) for males and at least 1.2 mg/dL (at least 106 µmol/L) for females;
- 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;
- Metformin, Januvia and/or Jardiance contraindications according to the product information;
- 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;
- Current treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents;
- Uncontrolled hypertension > 170/105 mmHg;
- Clinically significant ECG abnormalities or any acute cardiovascular events within the last 3 months;
- Consuming high doses of vitamin C (greater than or equal to 1,000 mg/day) or other health supplements and herbal remedies for the last two weeks that are considered could affect blood glucose control. Any supplements should be recorded as concomitant medications and dose should remain stable throughout the study period;
- Consumption of alcohol within the last 2 weeks. Participant unwilling to abstain from alcohol consumption for the course of this study. A wash-out period of 2 weeks prior to study entry is required.
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Interventions
This is a Phase I study to assess the safety and efficacy of DCB-DM101 add-on therapy in subjects with Type 2 Diabetes Mellitus who are inadequately controlled on Metformin and Sitagliptin or Metformin and Empagliflozin. Evaluable Type 2 Diabetes Mellitus subjects will be recruited and allocated to one of the following three treatment arms whereby the add-on therapy will be once daily (taken in the morning) for 7 consecutive days in total: Treatment Arm 1) 8 participants currently taking metformin (greater than or equal to 850 mg/day) + sitagliptin (greater than or equal to 100 mg/day) will add the study drug (DCB-DM101: 2x 165 mg tablets taken orally once per day) to their treatments. Treatment Arm 2) 8 participants currently taking metformin (greater than or equal to 850 mg/day) + empagliflozin (greater than or equal to 10 mg/day) will add the study drug (DCB-DM101: 2x 165 mg tablets taken orally once per day) to their treatments. Treatment Arm 3) 8 participants who are currently taking metformin (greater than or equal to 850 mg/day) + sitagliptin (greater than or equal to 100 mg/day) will add oral (tablet) empagliflozin (1x 10 mg tablet once per day) to their treatments. Participants will record daily dosing in a participant dairy and all study drug dispensed will be returned at the end of the study. Study drug accountability will be monitored.
Locations(1)
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ACTRN12618001140246