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Completed

NCT Number: NCT02949193

Efficacy and Safety of Evogliptin add-on to Metformin in Patients With type2 Diabetes

This is a randomized, double-blind, active-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kangbuk Samsung Medical Center

Seoul, 110-746, South Korea

About this study

  • Evogliptin 5mg Group: Administration with Evogliptin 5mg add-on to metformin for 0-52 weeks.
  • Sitagliptin 100mg Group: Administration with Sitagliptin 100mg add-on to metformin for 0-24 weeks, and with Evogliptin 5mg add-on to metformin for 24-52 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with 6.5%≤HbA1c≤11.0% at screening
  • Subjects treated with 1,000mg/day or higher dose of metformin for at least 6 weeks prior to screening among people treated with metformin monotherapy for at least 12 weeks before screening
  • Subjects with 20kg/m2≤BMI≤40kg/m2 at screening

Exclusion criteria

  • Subjects with fasting plasma glucose≥270mg/dL at screening
  • Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
  • Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening
  • Subjects with ALT and AST 2.5 times or higher than upper normal range

Treatment and study plan

Evogliptin

Drug

evogliptin 5mg tablet qd + placebo tablet matching to sitagliptin 100mg

Other names: Suganon

Sitagliptin

Drug

sitagliptin 100 mg tablet qd + placebo tablet matching to evogliptin 5mg

Other names: januvia

Primary outcomes

  1. HbA1c

    Time frame: Change from baseline at 24 week

    unit: %

Secondary outcomes

  1. fasting plasma glucose

    Time frame: Change from baseline at 24 week

    unit : mg/dL

  2. HOMA-beta

    Time frame: Change from baseline at 24 week

    unit: %

  3. HbA1c response rate

    Time frame: Change from baseline at 24 weeks

    unit: %

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

A Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Oct 31, 2016
Registry last updated
Oct 31, 2016

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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