T2DM (Type 2 Diabetes Mellitus)
Conditions
Brief summary
A Multi-center, Open-label, Extension study to Evaluate the long term Safety and Efficacy of DWP16001 add-on to metformin in Patients with type 2 diabetes mellitus inadequately controlled on metformin
Interventions
DRUGDWP16001
DWP16001 Tablets
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participated in the prior phase 3 study (Protocol No: DW\_DWP16001302) for meeting the inclusion criteria and completed the study * Voluntarily decided to participate in the extension study and provided a written consent on the consent form
Exclusion criteria
* Withdrawn from the prior phase 3 study (Protocol No: DW\_DWP16001302) or expected of having safety issue if taking part in the study in the judgment of the investigator * Subjects with the following diseases or signs: * Diabetic ketoacidosis * Moderate to severe renal impairment (estimated glomerular filtration rate \[eGFR\] \< 60 mL/min/1.73 m2 * Females who are pregnant or breast-feeding, or subjects who do not agree to the use of appropriate contraceptive methods throughout the study Subjects must agree to one of the following appropriate contraceptive methods for subjects or their partners: ① Either surgical sterilization (vasectomy, etc.) or insertion of an intrauterine device (copper loop, intrauterine hormone-containing system), or ② A physical barrier method combined with either systemic hormonal contraceptives or spermicide, or ③ Use of male condom combined with either cervical cap or diaphragm Determined to be ineligible for the study by the investigator, besides the above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in Adverse events (AEs) and adverse events of special interest (AESIs)* at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP | at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP | \*Hypoglycemia, urinary tract infection, genital infection, pollakiuria, or polyuria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline* in HbA1c at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP | at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP | \* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW\_DWP16001302) |
| Changes from baseline* in FPG at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP | at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP | \* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW\_DWP16001302) |
| Proportion of subjects achieving HbA1c target of < 7% at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP | at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP | \* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW\_DWP16001302) |
Countries
South Korea
Outcome results
None listed