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出境医 / 临床实验 / Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus
Study Description
Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| T2DM (Type 2 Diabetes Mellitus) | Drug: DWP16001 Drug: Placebo | Phase 2 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 196 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | July 10, 2019 |
| Estimated Primary Completion Date : | March 2020 |
| Estimated Study Completion Date : | June 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: DWP16001 Amg
DWP16001 Amg, Tablets, Orally, Once daily
|
Drug: DWP16001
DWP16001 tablets
Drug: Placebo DWP16001 placebo-matching tablets
|
|
Experimental: DWP16001 Bmg
DWP16001 Bmg, Tablets, Orally, Once daily
|
Drug: DWP16001
DWP16001 tablets
Drug: Placebo DWP16001 placebo-matching tablets
|
|
Experimental: DWP16001 Cmg
DWP16001 Cmg, Tablets, Orally, Once daily
|
Drug: DWP16001
DWP16001 tablets
Drug: Placebo DWP16001 placebo-matching tablets
|
|
Placebo Comparator: Placebo
Placebo, Tablets, Orally, Once daily
|
Drug: Placebo
DWP16001 placebo-matching tablets
|
Outcome Measures
Primary Outcome Measures :
- Change from baseline in HbA1c [ Time Frame: at 12 weeks ]
Secondary Outcome Measures :
- 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 ]
Eligibility Criteria
| Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Contacts
| Contact: Choi | jhchoi413@daewoong.co.kr | ||
| Contact: Hyun | wrhyun075@daewoong.co.kr |
Locations
| Korea, Republic of | |
| Daewoong pharmatceutical | Recruiting |
| Seoul, Korea, Republic of | |
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 7, 2019 | ||||||||
| First Posted Date ICMJE | July 10, 2019 | ||||||||
| Last Update Posted Date | July 18, 2019 | ||||||||
| Actual Study Start Date ICMJE | July 10, 2019 | ||||||||
| Estimated Primary Completion Date | March 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change from baseline in HbA1c [ Time Frame: at 12 weeks ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study to Evaluate the Efficacy and Safety of DWP16001 in Patients With Type 2 Diabetes Mellitus | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | T2DM (Type 2 Diabetes Mellitus) | ||||||||
| Intervention ICMJE |
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
196 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 2020 | ||||||||
| Estimated Primary Completion Date | March 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 20 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | Korea, Republic of | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04014023 | ||||||||
| Other Study ID Numbers ICMJE | DWP16001201 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Daewoong Pharmaceutical Co. LTD. | ||||||||
| Study Sponsor ICMJE | Daewoong Pharmaceutical Co. LTD. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Daewoong Pharmaceutical Co. LTD. | ||||||||
| Verification Date | July 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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