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Completed

NCT Number: NCT05376969

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

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Key information

Conditions

T2DM (Type 2 Diabetes Mellitus) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Daewoong pharmatceutical

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Withdrawn from the prior phase 3 study (Protocol No: DW_DWP16001302) or expected of having safety issue if taking part in the study in the judgment of the investigator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

Treatment and study plan

DWP16001

Drug

DWP16001 Tablets

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

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

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

Secondary outcomes

  1. Changes from baseline* in HbA1c at Weeks 6, 12, 18, 24, 38, and 52 after administration of the IP

    Time frame: 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

    Time frame: 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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Acronym: ENHANCE-MEXT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 17, 2022
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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