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

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05376969
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
11.2
Anticipated Duration (Months)
8.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 25, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: DWP16001 Amg

DWP16001 Amg, Tablets, Orally, Once daily

Drug: DWP16001
DWP16001 Tablets

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

  1. 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)

  2. 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)

  3. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Daewoong pharmatceutical Seoul Korea, Republic of

Sponsors and Collaborators

  • Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT05376969
Other Study ID Numbers:
  • DW_DWP16001302_Ext
First Posted:
May 17, 2022
Last Update Posted:
May 17, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of May 17, 2022