Clinical trial NCT06141980: Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus
Official title: A Multi-center, phase3, Open-label Study to Evaluate the Long Term Safety and Efficacy of DWP16001 in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Gemigliptin
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: T2DM (Type 2 Diabetes Mellitus)
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-11-21
Enrollment: 134
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period.

At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial.

The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.

Detailed description: The subjects, having voluntarily agreed to participate in the clinical trial and provided informed consent, will undergo screening tests. During Visit 1 (Screening), subjects meeting the inclusion/exclusion criteria will go through an 8-week stabilization period. Throughout this period, subjects will receive concurrent administration of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day), and will have a washout period for other oral antidiabetic drugs.

At Visit 1-1, central laboratory tests will be conducted. If the test results meet the criteria for Visit 2 (Enrollment Visit), the subject will be eligible to participate in the clinical trial.

The subjects will receive the investigational drug (DWP16001 0.3 mg) once a day for 52 weeks. They will visit the clinical trial site at weeks 8, 16, 24, 38, and 52 for safety and efficacy assessments during the 52-week treatment period.

Eligibility criteria: Inclusion Criteria:

1. Subjects with T2DM age 19 \~ under 80 years
2. Subjects who have 7% ≤ HbA1c ≤ 11% in screening visit(V1-1)
3. Subjects who have FPG \<270 mg/dl screening visit(V1-1)
4. Subjects who have received a combination of metformin (≥1,000 mg/day) and gemigliptin (50 mg/day) for a minimum of 8 weeks prior to Visit 2 (Enrollment Visit)
5. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Exclusion Criteria:

1. Subjects with current or history of hypersensitivity to the IP of this study, metformin or drugs of the same class and their components (e.g., history of hypersensitivity to biguanide or SGLT2 inhibitors)
2. Diabetic ketoacidosis, diabetic coma or precoma within the past year
3. Urinary tract infections or genital infections within
4. Uncontrolled hypertension (SBP \> 180 mmHg or DBP \> 110 mmHg)
5. eGFR \< 45 mL/min/1.73 m2
6. Severe heart failure (NYHA class III/IV

Primary outcomes:
measure: Safety outcomes_Adverse events occurred during clinical trials
timeFrame: from baseline up to 52 weeks
measure: Safety outcomes_ Change of blood pressure
timeFrame: from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP
measure: Safety outcomes_ Change of heartbeat
timeFrame: from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP
measure: Safety outcomes_ Change of body temperature
timeFrame: from baseline to Week 8, 16, 24, 38, and 52 after administration of the IP
measure: Efficacy outcome_Change of HbA1c
timeFrame: from Baseline at Week 8, 16, 24, 38, and 52 after administration of the IP
measure: Efficacy outcome_Change of FPG
timeFrame: from baseline at Week 8, 16, 24, 38, and 52 after administration of the IP
measure: Efficacy outcome_Proportion of subjects achieving HbA1c target of < 6.5%
timeFrame: at Weeks 8, 16, 24, 38 and 52 after administration of the IP
measure: Efficacy outcome_Proportion of subjects achieving HbA1c target of < 7.0 %
timeFrame: at Weeks 8, 16, 24, 38 and 52 after administration of the IP
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Soo Lim, MD, PH.D
role: PRINCIPAL_INVESTIGATOR
References: