Type2 DiabetesPhase 1NCT03033433

DCB-DM101 in Healthy Volunteers and for Type 2 Diabetes Mellitus Patients

A Phase 1 study testing DCB-DM101 in people with Type2 Diabetes, run by VitNovo, Inc. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

An Open-Label Phase I Study to Assess the Safety and Tolerability Profile of Three Escalating Doses of DCB-DM101 in Healthy Volunteers and Optimum Dose of DCB-DM101 as Add-on Treatment in Type 2 Diabetes Mellitus (T2DM) Patients Read more about this study

Who is it for?: Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Type2 Diabetes
What is being tested?: DCB-DM101
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteTaiwan
Study dates: Oct 2016to Aug 2018
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Stage 1
Adult, male or female aged between 20-40 years old;
Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest X-rays, and electrocardiogram;
Body Mass Index (BMI) between 18.5 and 24, inclusive, (BMI will be calculated as weight in kilogram [kg]/height in meters2 [m2]);
Clinically normal hematology, biochemistry and urinalysis determinations based on investigator's discretion;
Subject is willing and able to comply with study procedures and sign informed consent.

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Stage 2
Male or female aged between 20-70 years old;
Diagnosed T2DM (WHO 1999 criteria);
Not effective in alleviating T2DM after monotherapy of metformin 1,500mg/day [or 1,000mg/day if unable to tolerate higher dose] for 3 months
HbA1c of 7.0 % to 9.0% (inclusive);
BMI of at most 35 kg/m2;
Subject is willing and able to comply with study procedures and sign informed consent

Who cannot join

Stage 1
Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with the assessments of safety or pharmacodynamics variables during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, musculoskeletal or hematological disease as determined by the clinical judgment of the investigator;
Subject has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug;
Subjects have taken or potentially take any prescription medication and/or over the-counter medication from within 1 week prior to the first dose of study drug to the end of study period;
Subject has alcohol, caffeine, grapefruit juice, or nicotine consumption within 24 hours prior to the administration of study drug;
Female subject of childbearing potential who: is lactating; or has positive urine pregnancy test at Visit 1; or refuses to adopt at least two forms of birth control (at least one of which must be a barrier method) during the study.

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Stage 2
Known or suspected allergy to any ingredients of study product
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.
Note: Acceptable forms include:
Established use of oral, injected or implanted hormonal methods of contraception.
Placement of an intrauterine device (IUD) or intrauterine system (IUS).
Barrier methods of contraception: Condom OR Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. 3. Participated in another clinical trial and received an investigational drug within four 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 115 umol/L) for males and at least 1.2 mg/dL (at least 106 umol/L) for females
With any uncontrolled illness or a history of any illness judged by the investigator that entering the trial may be detrimental to the subject
Metformin contraindications according to the package insert
Current treatment with systemic corticosteroids.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Tri-Service General Hospital
Taipei, 114

Other trials in Taiwan

About this study

Official title: An Open-label Phase I Study to Assess the Safety and Tolerability Profile of Three Escalating Doses of DCB-DM101 in Healthy Volunteers and Optimum Dose of DCB-DM101 as add-on Treatment in Type 2 Diabetes Mellitus (T2DM) Patients

Read the detailed description

This is a single center, open-label, phase-I study consisting of two stages: Stage 1 will be dose-escalation study to assess the safety and tolerability profile of three escalating doses of DCB-DM101 in healthy volunteers and Stage 2 will apply optimum dose of DCB-DM101 as add-on treatment in T2DM patients. In Stage 2, patients are allowed to receive metformin for T2DM for routine use of which the dosing regimen should not be adjusted. No other medication/treatments for T2DM are allowed. Stage 2 can only be proceeded upon the approval of health authority in Taiwan. After determining the optimal dose for Stage 2, the reasons for determining such dose together with relevant supporting data should be submitted to health authority in Taiwan for review and to determine whether stage 2 can be proceeded and which dose should be employed for stage 2.

Conditions: Type2 Diabetes
Being tested: DCB-DM101

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DCB-DM101Drug
determination of optimal dose for Stage 2

Study groups in NCT03033433
Study group	Role	What they receive
DCB-DM101, 500 mg tablet, determination of optimal dose	Experimental	Stage 1:Dose level 1(1 tablet of DCB-DM101 q.d. for 7 days orally);Dose level 2(2 tablets of DCB-DM101 q.d. for 7 days orally);Dose level 3(4 tablets of DCB-DM101 q.d. for 7 days orally) Stage 2:Optimum dose of DCB-DM101 determined in Stage 1 as add-on treatment in T2DM patients for 14 days, q.d., orally Receives: Drug: DCB-DM101

What is being measured

The primary outcome is the main question the study is designed to answer.

Stage 1: Optimal dose for Stage 2, dose limiting toxicity (DLT)
Primary endpoint, DLT is defined as: Any causally related adverse event as judged by investigator is greater than or equal to Grade 2. The causality of each adverse event to investigational product will be judged by investigator during the conduction of each dosing cohort in Stage I. DSMB will reevaluate the causality of each DLT after the completion or termination of this dosing cohort judged by investigator to determine whether dose escalation or entering to stage 2 can be proceeded.Optimal Dose will be one tablet or two tablets or 4 tablets. the optimal dose for stage 2 is defined using rules as follows but will be determined by sponsor and investigators.
Measured: 7 months
Stage 2: Number of Participants with Adverse events and Serious adverse events that are related to treatment
Specified:Primary endpoint, An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study medication, whether or not related to the study medication.
A Serious Adverse Event is defined as an AE meeting one of the following conditions. Death during the period of protocol defined surveillance. Life threatening Event defined as a participant at immediate risk of death at the time of the event. An event requiring inpatient hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance. Results in congenital anomaly or birth defect. Results in a persistent or significant disability and incapacity.
Measured: 3 months

Secondary outcomes (4)

Stage1: Number of Participants with Adverse events and Serious adverse events that are related to treatment
Secondary endpoint, An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study medication, whether or not related to the study medication.
A Serious Adverse Event is defined as an AE meeting one of the following conditions. Death during the period of protocol defined surveillance. Life threatening Event defined as a participant at immediate risk of death at the time of the event. An event requiring inpatient hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance. Results in congenital anomaly or birth defect. Results in a persistent or significant disability and incapacity.
Measured: 7 months
Stage2: Change from baseline in results of oral glucose tolerance test (OGTT)
While patient takes OGTT at Screening visit, blood glucose will be monitor at right before, 0.5, 1, 1.5, and 2 hr after administration of solution containing 75 g glucose. While at visit 2 and 4, blood glucose will be monitored at pre-dose, right before taking solution containing 75 g glucose(30 mins after dosing), 1, 1.5, 2, and 2.5 hr after administration of dose.
Measured: 0 (pre-dose) and 0.5, 1, 1.5, 2, 2.5 hours post-dose
Stage2: Change from baseline in biomarker( serum insulin) testing results.
Biomarker consists of serum insulin. Insulin will be measured at all the same time points where blood glucose is measured including OGTT test time points for Visits 1 (-30 to 1 days), 2 (Day 1), and 4(Day 14), and single blood sampling besides laboratory test for Visits 3 (Day 8) and 5 (Day 28).
Measured: Visits 1 (-30 to 1 days), Visit 2 (Day 1), Visits 3 (Day 8), Visit 4(Day 14)and 5 (Day 28).
Stage2: Change from baseline in biomarker( serum fructosamine) testing results.
Fructosamine at will be measured at Visit 1 (-30 to 1 days), Visit 3 (Day 8), Visit 4 (Day 14), and Visit 5 (Day 28).
Measured: Visit 1 (-30 to 1 days), Visit 3 (Day 8), Visit 4 (Day 14), and Visit 5 (Day 28).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Aug 2018

First posted26 Jan 2017 (estimated)
Study startOct 2016
Primary completionDec 2017
Study completionAug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03033433
Sponsor's protocol ID: DCB-DM101-CP001
Status last verified: Dec 2016
First submitted: 25 Dec 2016
Last updated: 16 Oct 2018
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Phase I Study to Assess the Safety and Tolerability Profile of Three Escalating Doses of DCB-DM101 in Healthy Volunteers and Optimum Dose of DCB-DM101 as add-on Treatment in Type 2 Diabetes Mellitus (T2DM) Patients
ClinicalTrials.gov ID: NCT03033433
Acronym / sponsor ID: DCB-DM101-CP001
Conditions: Type2 Diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: VitNovo, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2016 (actual)
Primary completion: Dec 2017 (actual)
Study completion: Aug 2018 (actual)
First posted: 26 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DCB-DM101, 500 mg tablet, determination of optimal dose	Experimental	Drug: DCB-DM101Stage 1:Dose level 1(1 tablet of DCB-DM101 q.d. for 7 days orally);Dose level 2(2 tablets of DCB-DM101 q.d. for 7 days orally);Dose level 3(4 tablets of DCB-DM101 q.d. for 7 days orally) Stage 2:Optimum dose of DCB-DM101 determined in Stage 1 as add-on treatment in T2DM patients for 14 days, q.d., orally

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Stage 1
Adult, male or female aged between 20-40 years old;
Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest X-rays, and electrocardiogram;
Body Mass Index (BMI) between 18.5 and 24, inclusive, (BMI will be calculated as weight in kilogram [kg]/height in meters2 [m2]);
Clinically normal hematology, biochemistry and urinalysis determinations based on investigator's discretion;

Key exclusion criteria (18 listed)

Stage 1
Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with the assessments of safety or pharmacodynamics variables during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, musculoskeletal or hematological disease as determined by the clinical judgment of the investigator;
Subject has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug;
Subjects have taken or potentially take any prescription medication and/or over the-counter medication from within 1 week prior to the first dose of study drug to the end of study period;
Subject has alcohol, caffeine, grapefruit juice, or nicotine consumption within 24 hours prior to the administration of study drug;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DCB-DM101determination of optimal dose for Stage 2	Drug	DCB-DM101, 500 mg tablet, determination of optimal dose

Primary outcome

Stage 1: Optimal dose for Stage 2, dose limiting toxicity (DLT)
Time frame: 7 months
Primary endpoint, DLT is defined as: Any causally related adverse event as judged by investigator is greater than or equal to Grade 2. The causality of each adverse event to investigational product will be judged by investigator during the conduction of each dosing cohort in Stage I. DSMB will reevaluate the causality of each DLT after the completion or termination of this dosing cohort judged by investigator to determine whether dose escalation or entering to stage 2 can be proceeded.Optimal Dose will be one tablet or two tablets or 4 tablets. the optimal dose for stage 2 is defined using rules as follows but will be determined by sponsor and investigators.
Stage 2: Number of Participants with Adverse events and Serious adverse events that are related to treatment
Time frame: 3 months
Specified:Primary endpoint, An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a study medication and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study medication, whether or not related to the study medication. A Serious Adverse Event is defined as an AE meeting one of the following conditions. Death during the period of protocol defined surveillance. Life threatening Event defined as a participant at immediate risk of death at the time of the event. An event requiring inpatient hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance. Results in congenital anomaly or birth defect. Results in a persistent or significant disability and incapacity.

4 secondary outcomes

Stage1: Number of Participants with Adverse events and Serious adverse events that are related to treatment
Time frame: 7 months
Stage2: Change from baseline in results of oral glucose tolerance test (OGTT)
Time frame: 0 (pre-dose) and 0.5, 1, 1.5, 2, 2.5 hours post-dose
Stage2: Change from baseline in biomarker( serum insulin) testing results.
Time frame: Visits 1 (-30 to 1 days), Visit 2 (Day 1), Visits 3 (Day 8), Visit 4(Day 14)and 5 (Day 28).
Stage2: Change from baseline in biomarker( serum fructosamine) testing results.
Time frame: Visit 1 (-30 to 1 days), Visit 3 (Day 8), Visit 4 (Day 14), and Visit 5 (Day 28).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yi-Jen Hung, MD principal investigator

Tri-Service General Hospital (TSGH)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DCB-DM101 in people with Type2 Diabetes, run by VitNovo, Inc. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stage 1: Optimal dose for Stage 2, dose limiting toxicity (DLT) (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03033433.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.