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Trial registered on ANZCTR


Registration number
ACTRN12618001140246
Ethics application status
Approved
Date submitted
29/06/2018
Date registered
11/07/2018
Date last updated
29/08/2019
Date data sharing statement initially provided
29/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
DCB-DM101 in Participants with Type 2 Diabetes Mellitus
Scientific title
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.
Secondary ID [1] 294338 0
Nil known
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 307059 0
Condition category
Condition code
Metabolic and Endocrine 306169 306169 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 300644 0
Treatment: Drugs
Comparator / control treatment
The comparator treatment in this study is Jardiance (empagliflozin),

1x 10mg empagliflozin single oral tablet will be taken in the morning once daily by the subject for 7 consecutive days. It will be an add-on treatment to metformin and sitagliptin in treatment Arm 3.
Control group
Active

Outcomes
Primary outcome [1] 306505 0
Incidence of treatment-emergent AEs and SAEs assessed by participant-reported, medical records, data linkage, hospital records and directly observed.
Timepoint [1] 306505 0
Up to 7 days after start of add-on treatment.
Primary outcome [2] 306506 0
Changes from baseline in vital signs (including weight, body mass index, blood pressure using certified weight balance scales, NSW health BMI calculator and certified automatic blood pressure machine),
Timepoint [2] 306506 0
Once at baseline and at 7 days after start of add-on treatment.
Primary outcome [3] 306544 0
Changes from baseline in physical examination by a trained physician of a participants body systems (including cardiovascular, skin, respiratory, neurological, abdomen, lymph nodes, EENT (eyes, ears, nose and throat), spine, and extremities). Examinations will include the standard physician physical examination techniques; inspection, palpation, percussion, and auscultation.
Timepoint [3] 306544 0
Once at baseline and at 7 days after start of add-on treatment.
Secondary outcome [1] 348706 0
Change from baseline in results of oral glucose tolerance test (OGTT).
Timepoint [1] 348706 0
Once at baseline and at 7 days after start of add-on treatment.
Secondary outcome [2] 348707 0
Change from baseline in blood glucose biomarker testing results.
Timepoint [2] 348707 0
Once at baseline and at 7 days after start of add-on treatment.
Secondary outcome [3] 348820 0
Change from baseline in plasma insulin biomarker testing results.
Timepoint [3] 348820 0
Once at baseline and at 7 days after start of add-on treatment.
Secondary outcome [4] 348821 0
Change from baseline in glucagon biomarker testing results.
Timepoint [4] 348821 0
Once at baseline and at 7 days after start of add-on treatment.
Secondary outcome [5] 348822 0
Primary outcome:

Changes from baseline in laboratory assessment results (haematology and biochemistry).

The haematology assessments will include measuring haemaglobin, haematocrit, red blood cell count, reticulocytes, MCH, MCHC, platelet count, white cell count, absolute neutrophil, basophil, eosinophil, lymphocyte and monocyte count. The biochemisty assessments will include measuring sodium, potassium, chloride, calcium, phosphate, urea, creatinine, LDH, total bilirubin, ALP, AST, GGT, albumin, total protein.
Timepoint [5] 348822 0
Once at baseline and at 7 days after start of add-on treatment.
Secondary outcome [6] 348859 0
Primary Outcome:

Change from baseline in ECG (PR, QT, QTcF intervals and QRS duration) using a validated 12-lead ECG machine.
Timepoint [6] 348859 0
Once at baseline and at 7 days after start of add-on treatment.

Eligibility
Key inclusion criteria
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.
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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;
10. Uncontrolled hypertension > 170/105 mmHg;
11. Clinically significant ECG abnormalities or any acute cardiovascular events within the last 3 months;
12. 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;
13. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants eligible for either treatment arm 1 or 3 will be allocated on an alternate basis.
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/07/2018
Actual
16/07/2018
Date of last participant enrolment
Anticipated
Actual
6/03/2019
Date of last data collection
Anticipated
Actual
20/03/2019
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11258 0
Pendlebury Research - Adamstown
Recruitment postcode(s) [1] 24087 0
2289 - Kotara

Funding & Sponsors
Funding source category [1] 298982 0
Commercial sector/Industry
Name [1] 298982 0
VitNovo Australia Pty Ltd
Country [1] 298982 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
VitNovo Australia Pty Ltd
Address
VitNovo Australia Pty Ltd
198 Jasper Rd,
Bentleigh, Victoria,
Australia, 3204
Country
Australia
Secondary sponsor category [1] 298206 0
None
Name [1] 298206 0
Address [1] 298206 0
Country [1] 298206 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299911 0
Bellberry Limited
Ethics committee address [1] 299911 0
Ethics committee country [1] 299911 0
Australia
Date submitted for ethics approval [1] 299911 0
Approval date [1] 299911 0
06/06/2018
Ethics approval number [1] 299911 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81962 0
Dr Erwin Sunjoto
Address 81962 0
Pendlebury Research Pty Ltd
Suite 7, Level 2, 10 Bradford Close,
Kotara, NSW, 2289
Country 81962 0
Australia
Phone 81962 0
+61 (02) 02 4089 3744
Fax 81962 0
Email 81962 0
erwin@pendleburyresearch.com.au
Contact person for public queries
Name 81963 0
Luke Edington
Address 81963 0
Datapharm Australia Pty Ltd
56-56A Thompson St
Drummoyne, NSW, 2047
Country 81963 0
Australia
Phone 81963 0
+61 2 9719 2800
Fax 81963 0
Email 81963 0
luke.edington@datapharmaustralia.com
Contact person for scientific queries
Name 81964 0
Pei-Ran Wang
Address 81964 0
VitNovo, Inc.
6F., No.300, Sec. 4, Zhongxiao. E. Rd.,
Da'an Dist., Taipei City 10694
Country 81964 0
Taiwan, Province Of China
Phone 81964 0
+886 2 2778 2578
Fax 81964 0
Email 81964 0
peiran.wang@vitnovo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This clinical trial studies a new drug that has not yet been approved by any regulatory authority. The Sponsor intends to continue developing the product and may at a future date seek regulatory approval of the study drug.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.