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OpenTrials
Completed

NCT Number: NCT04170998

Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

Completed

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul St, Mary's Hospital,The Catholic University of Korea

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with Type II diabetes mellitus aged 19 years or older
  • Subjects who performed Dual therapies (complex allowed) for one of the following, along with meals and exercise therapy
  • Subjects who are receiving metformin ≥ 1000 mg/d and dapagliflozin 10 mg/d at the same dose for at least 8 weeks prior to the screening visit
  • Subjects who are receiving metformin ≥ 1000 mg/d and SGLT-2 inhibitor except for dapagliflozin at the same dose for at least 8 weeks prior to the screening visit
  • Subjects with 7.0%≤HbA1c≤10.5% at screening visit
  • Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit
  • Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening visit

Exclusion criteria

  • Patients with type 1 diabetes, secondary diabetes, gestational diabetes, diabetic ketoacidosis, diabetic coma, pre-coma, lactic acidosis, and acute or chronic metabolic acidosis
  • patients with Hypopituitarism or adrenal insufficiency, pulmonary infarction, severe pulmonary dysfunction and other hypoxemia
  • Patients with severe infectious disease or severe traumatic systemic disorders
  • End stage renal disease or dialysis patients
  • Patients with Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Subjects with Liver cirrhosis, chronic active hepatitis B or C, cholecystitis, acromegaly, asthma or major skin allergies

Treatment and study plan

Evogliptin 5mg

Drug

Participants receive Evogliptin 5mg orally once a day

Other names: Suganon

Evogliptin Placebo

Drug

Participants receive placebo to match Evogliptin 5mg orally once a day

Other names: Placebo

Dapagliflozin 10mg

Drug

Participants receive Dapagliflozin orally once a day

Other names: Forxiga

Metformin ≥ 1000mg

Drug

Metformin are administered at the same dose and formulation.

Primary outcomes

  1. Change from baseline in HbA1c (%) After 24 weeks

    Time frame: 24 weeks

Secondary outcomes

  1. Change from baseline in FPG(mg/dL) After 24 weeks

    Time frame: 24 weeks

  2. Change from baseline in HbA1c response rate(<7.0% ,<6.5%) After 24 weeks

    Time frame: 24 weeks

  3. Change from baseline in 7-point SMBG After 24 weeks

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin and Dapagliflozin Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 20, 2019
Registry last updated
Dec 10, 2021

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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