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

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

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 Overview

• Status: Completed
• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Intervention / Treatment: Drug: DWP16001

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Daewoong pharmatceutical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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• Withdrawn from the prior phase 3 study (Protocol No: DW_DWP16001302) or expected of having safety issue if taking part in the study in the judgment of the investigator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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DWP16001 Amg; DWP16001 Amg, Tablets, Orally, Once daily	Drug: DWP16001; DWP16001 Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline* in HbA1c 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)	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	* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW_DWP16001302)	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	* Visit 2 (randomization) of the prior phase 3 study (Protocol No: DW_DWP16001302)	at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 25, 2021
• Primary Completion (ACTUAL): May 16, 2022
• Study Completion (ACTUAL): May 16, 2022

Study Registration Dates

• First Submitted: January 9, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (ACTUAL): May 17, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 23, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DW_DWP16001302_Ext

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No