T2DM (Type 2 Diabetes Mellitus)Phase 2NCT04014023
Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing DWP16001 in people with T2DM (Type 2 Diabetes Mellitus), run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the efficacy and safety of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- DWP16001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jul 2019to Jun 2020
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 to 80 years
- Patients who was diagnosed with type 2 diabetes mellitus at least 8 weeks before
- Body Mass Index (BMI) between 20 and 45 kg/㎡
- Patients with 7% ≤ HbA1c ≤ 10% at screening
- Subject who has conducted a stable diet and exercise for at least 8 weeks
Who cannot join
- Type 1 diabetes mellitus or secondary diabetes
- Severe diabetes complications (proliferative diabetic retinopathy, stage 4 or higher nephropathy or severe diabetic neuropathy, diabetic ketoacidosis)
- Clinical significantly renal disorders
- Creatinine clearance < 60ml/min (0.84ml/s/㎡) or Glomerular filtration rate(eGFR) < 60mL/min/1.73
- Severe gastrointestinal disorder
- Uncontrolled hypertension (SBP >180 mmHg or DBP > 110 mmHg)
- History of Acute coronary syndrome, unstable angina, myocardial infarction requiring hospitalization, stroke, transient ischemic attack, severe heart failure (NYHA class III/IV), or heart arrhythmia
Trial locations and contacts
1 site in 1 country.
Choi contact
Hyun contact
About this study
Official title: A Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase 2, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to determine the efficacy and safety of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- DWP16001, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP16001Drug
DWP16001 tablets
PlaceboDrug
DWP16001 placebo-matching tablets
| Study group | Role | What they receive |
|---|---|---|
| DWP16001 Amg | Experimental | DWP16001 Amg, Tablets, Orally, Once daily Receives: Drug: DWP16001; Drug: Placebo |
| DWP16001 Bmg | Experimental | DWP16001 Bmg, Tablets, Orally, Once daily Receives: Drug: DWP16001; Drug: Placebo |
| DWP16001 Cmg | Experimental | DWP16001 Cmg, Tablets, Orally, Once daily Receives: Drug: DWP16001; Drug: Placebo |
| Placebo | Placebo comparator | Placebo, Tablets, Orally, Once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c
Measured: at 12 weeks
Secondary outcomes (2)
Change from baseline in FPG
Measured: at week 4, 8, 12
The proportion of patients who achieve HbA1c < 7.0%, HbA1c < 6.5% and HbA1c reduction >0.5% from baseline
Measured: at week 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start10 Jul 2019
- Primary completionMar 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014023
- Sponsor's protocol ID
- DWP16001201
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-Blind, Placebo-controlled, Phase 2, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04014023
- Acronym / sponsor ID
- DWP16001201
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 10 Jul 2019 (actual)
- 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.
The purpose of this study is to determine the efficacy and safety of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DWP16001 Amg | Experimental | Drug: DWP16001, Drug: PlaceboDWP16001 Amg, Tablets, Orally, Once daily |
| DWP16001 Bmg | Experimental | Drug: DWP16001, Drug: PlaceboDWP16001 Bmg, Tablets, Orally, Once daily |
| DWP16001 Cmg | Experimental | Drug: DWP16001, Drug: PlaceboDWP16001 Cmg, Tablets, Orally, Once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, Tablets, Orally, Once daily |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 20 to 80 years
- Patients who was diagnosed with type 2 diabetes mellitus at least 8 weeks before
- Body Mass Index (BMI) between 20 and 45 kg/㎡
- Patients with 7% ≤ HbA1c ≤ 10% at screening
- Subject who has conducted a stable diet and exercise for at least 8 weeks
Key exclusion criteria (7 listed)
- Type 1 diabetes mellitus or secondary diabetes
- Severe diabetes complications (proliferative diabetic retinopathy, stage 4 or higher nephropathy or severe diabetic neuropathy, diabetic ketoacidosis)
- Clinical significantly renal disorders
- Creatinine clearance < 60ml/min (0.84ml/s/㎡) or Glomerular filtration rate(eGFR) < 60mL/min/1.73
- Severe gastrointestinal disorder
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 |
|---|---|---|
| DWP16001DWP16001 tablets | Drug | DWP16001 Amg, DWP16001 Bmg, DWP16001 Cmg |
| PlaceboDWP16001 placebo-matching tablets | Drug | DWP16001 Amg, DWP16001 Bmg, DWP16001 Cmg, Placebo |
Primary outcome
Change from baseline in HbA1c
Time frame: at 12 weeks
2 secondary outcomes
Change from baseline in FPG
Time frame: at week 4, 8, 12
The proportion of patients who achieve HbA1c < 7.0%, HbA1c < 6.5% and HbA1c reduction >0.5% from baseline
Time frame: at week 4, 8, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
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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.
Choi contact
Hyun contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DWP16001 in people with T2DM (Type 2 Diabetes Mellitus), run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Jul 2019. 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 South Korea. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Choi (jhchoi413@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in HbA1c (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2019.