Completed
T2DM

Phase III, Double Blind, Parallel-group, Randomized, Placebo Controlled Study to Compare the Efficacy and Safety of MP-513 When Added to Ongoing Metformin Monotherapy In Patients With Type 2 DM

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What is being tested

MP513

+ Placebo
Drug
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Phase 3
Interventional
Study Start: May 2012
See protocol details

Summary

Principal SponsorHandok Inc.
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2012Actual date on which the first participant was enrolled.

* Although many different oral antidiabetic agents are currently available, approximately 50% of treated Type 2 diabetic subjects do not reach currently accepted goals for HbA1c(Oral communication, American Diabetic Association, 2008) * Subjects are frequently prescribed agents which can cause hypoglycemia, and/or weight gain. Metformin does not usually have these unwanted effects, and it is the standard first line therapy in treating type 2 diabetic mellitus in European union. * Nonclinical pharmacodynamic studies revealed that MP-513 effectively improves glucose tolerance in animal models of type 2 diabetes, whilst the compound has very little potential to cause hypoglycaemia, the most commonly reported adverse event with many currently marketed products. * The nonclinical studies also suggested that the inhibitory effect of MP-513 on DPP-Ⅳ is more potent and durable than other DPP-Ⅳ inhibitors in development. The result in safety pharmacology and toxicology also revealed that MP-513 has a relatively wide margin for safety. * Thus, MP-513 is expected to have good efficacy and tolerability in subjects with type 2 diabetes mellitus by once-daily administration.

Official TitlePhase III, Double Blind, Parallel-group, Randomized, Placebo Controlled Study to Compare the Efficacy and Safety of MP-513 When Added to Ongoing Metformin Monotherapy In Patients With Type 2 DM 
Principal SponsorHandok Inc.
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
189 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled
: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria

Inclusion Criteria: 1. The subject is aged ≥18 years at signature of the ICF 2. The subject has had a documented diagnosis of Type 2 diabetes for at least 6 months at the screening visit 3. The subject's Type 2 diabetes is managed by metformin monotherapy ≥1000 mg/day, plus diet and exercise, as appropriate, and the dose has been unchanged for at least 56 consecutive days 4. The subject's HbA1c is 7.0%≤HbA1c\<10.0% 5. The subject's BMI is 20.0≤BMI≤40.0kg/m2 6. The subject's FPG is \<15 mmol/L (270 mg/dL) 7. The subject is capable of giving informed consent, complying with the restrictions and requirements of the protocol Exclusion Criteria: 1. The subject is suffering from any disease, including Type 2 diabetes or its complications that, in the opinion of the Investigator, is sufficiently severe to render the subject unfit, or affect the subject's ability, to participate in the study, for example: * Macroangiopathy with symptoms of coronary heart disease or peripheral arterial obstructive disease. * Microangiopathy with symptoms of (autonomous) neuropathy with any one or more of the following: gastroparesis * Symptoms of poor blood glucose control (polyuria, polydipsia or weight loss) 2. The subject has a history of Type 1 diabetes or a secondary form of diabetes 3. The subject has a history of allergy to MP-513, or to any of the excipients in the MP-513 tablet (eg. Mannitol) 4. The subject has a history of drug abuse 5. The subject drinks on average more than 28 units of alcohol per week(One unit of alcohol equals approximately 250 mL of beer, 125 mL of wine or 40 mL of spirits) 6. The subject has a medical history of unstable angina, or heart failure(New York Heart Association class Ⅲ-IV) or any clinically significant ECG abnormalities such as ventricular tachycardia or a medical history of ventricular tachycardia 7. The subject has participated in any other clinical study involving blood draws or administration of an unlicensed medicinal product within 12 weeks prior to the screening visit (This does not preclude a subject from being re-screened for this study at a later date within the 12 week period, provided they were not randomised ) 8. The subject has received insulin within 12 months prior to the screening visit, with the exception of insulin therapy during hospitalization, insulin therapy for medical conditions not requiring hospitalization (\<2 weeks duration) or use in gestational diabetes 9. The subject is suffering from serious concurrent renal disease or creatinine clearance \<60 mL/min 10. Non-surgically sterilised, pre-menopausal female subject, who does not agree to use a double barrier method of contraception from the screening visit until at least 14 days after the last dosing day (Examples of permitted types of contraception are: condoms, cervical cap in conjunction with spermicide, sterilisation and intra-uterine device. Oral contraception is permitted but must not be used as the sole method of contraception) 11. Female subjects whose pregnancy test is negative or who are pregnant, lactating, or are planning to become pregnant during the study 12. The subject is expected to require additional diabetic treatment for his/her Type 2 diabetes or its complications during the study after the screening visit 13. The subject has a clinically significant liver disease with aspartate-amino-transferase (AST) and alanine-amino-transferase (ALT) \>2.5 times the upper limit of normal (ULN) at the screening visit 14. The subject has diastolic blood pressure \>100 mmHg and/or systolic blood pressure \>180 mmHg at the screening visit 15. The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in the clinical study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental

form : Pink film-coated tablet for oral administration Dosage : 20mg/tablet frequency and duration: 1 tablet/day
Group II
Placebo

form : Pink film-coated tablet for oral administration Dosage : 20mg/tablet frequency and duration: 1 tablet/day
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Handok Pharmaceuticals CO. LTDSeoul, Korea, Republic ofSee the location
CompletedOne Study Center