Evaluate the Long Term Safety and Efficacy of DWP16001 add-on to Metformin in Patients With T2DM Inadequately Controlled on Metformin

NCT05376969 | Completed Phase 3

• 1 other identifier: DW_DWP16001302_Ext
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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

Conditions

T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (1)

• 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

  \*Hypoglycemia, urinary tract infection, genital infection, pollakiuria, or polyuria

  at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP

Secondary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

DWP16001 Amg

EXPERIMENTAL

DWP16001 Amg, Tablets, Orally, Once daily

Drug: DWP16001

Interventions

DWP16001 DRUG

DWP16001 Tablets

DWP16001 Amg

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily decided to participate in the extension study and provided a written consent on the consent form

You may not qualify if:

• Withdrawn from the prior phase 3 study (Protocol No: DW\_DWP16001302) or expected of having safety issue if taking part in the study in the judgment of the investigator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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Daewoong pharmatceutical

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Enavogliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: May 17, 2022
• Study Start: May 25, 2021
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Locations

KR (1)