Clinical trial NCT05376969: Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With T2DM Inadequately Controlled on Metformin
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: T2DM (Type 2 Diabetes Mellitus)
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 159
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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* Withdrawn from the prior phase 3 study (Protocol No: DW_DWP16001302) or expected of having safety issue if taking part in the study in the judgment of the investigator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

Primary outcomes:
measure: 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
timeFrame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Secondary outcomes:
measure: Changes from baseline* in HbA1c at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
timeFrame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
measure: Changes from baseline* in FPG at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
timeFrame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
measure: Proportion of subjects achieving HbA1c target of < 7% at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
timeFrame: at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Daewoong pharmatceutical
Study officials:
References: