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Type 2 DiabetesPhase 3T2DMNCT01805830

Teneligliptin(MP-513) vs. Placebo in Patient With Metformin Monotherapy

A Phase 3 study testing MP513 in people with Type 2 Diabetes, run by Handok Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study design of this trial is double blind, parallel-group, randomized, Placebo controlled study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
MP513
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
189 participants
Where
1 siteSouth Korea
Study dates
May 2012to Sep 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject is aged ≥18 years at signature of the ICF
  • The subject has had a documented diagnosis of Type 2 diabetes for at least 6 months at the screening visit
  • 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
  • The subject's HbA1c is 7.0%≤HbA1c<10.0%
  • The subject's BMI is 20.0≤BMI≤40.0kg/m2
  • The subject's FPG is <15 mmol/L (270 mg/dL)
  • The subject is capable of giving informed consent, complying with the restrictions and requirements of the protocol

Who cannot join

  • 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)
  • The subject has a history of Type 1 diabetes or a secondary form of diabetes
  • The subject has a history of allergy to MP-513, or to any of the excipients in the MP-513 tablet (eg. Mannitol)
Show all 18Show fewer
  • The subject has a history of drug abuse
  • 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)
  • 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
  • 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 )
  • 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
  • The subject is suffering from serious concurrent renal disease or creatinine clearance <60 mL/min
  • 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)
  • Female subjects whose pregnancy test is negative or who are pregnant, lactating, or are planning to become pregnant during the study
  • 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
  • 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
  • The subject has diastolic blood pressure >100 mmHg and/or systolic blood pressure >180 mmHg at the screening visit
  • The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in the clinical study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Handok Pharmaceuticals CO. LTD

    Seoul, Seoul

Other trials in South Korea

About this study

Official title: 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

The study design of this trial is double blind, parallel-group, randomized, Placebo controlled study.

Read the detailed description
  • 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.
Conditions
Type 2 Diabetes
Being tested
MP513, Placebo
Keywords
Type2DM / DPP-IV inhibitors
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MP513Drug

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

  • PlaceboDrug

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

Study groups in NCT01805830
Study groupRoleWhat they receive
MP513 groupExperimentalNot described
Receives: Drug: MP513
Placebo groupPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Measured: Change from Visit 1(Baseline Visit) in HbA1c at Visit 5(week 16)

Secondary outcomes (14)

  1. FPG(Fasting Plasma Glucose)

    Measured: Change from Visit 1(Baseline Visit) in FPG at Visit 5(week 16)

  2. Weight

    Measured: Change from Visit 1(Baseline Visit) in weight at Visit 5(week 16)

  3. BMI

    Measured: Change from Visit 1(Baseline Visit) in BMI at Visit 5(week 16)

  4. HbA1c <7.0%

    Measured: The proportion of patients who achieve an HbA1c<7.0% at Visit 5(week 16)

  5. HbA1c <6.5%

    Measured: The proportion of patients who achieve an HbA1c<6.5% at Visit 5(week 16)

  6. Total Cholesterol

    Measured: Change from Visit 1(Baseline Visit) in Total Cholesterol at Visit 5(week 16)

  7. LDL Cholesterol

    Measured: Change from Visit 1(Baseline Visit) in LDL Cholesterol at Visit 5(week 16)

  8. HDL Cholesterol

    Measured: Change from Visit 1(Baseline Visit) in HDL Cholesterol at Visit 5(week 16)

  9. Triglyceride

    Measured: Change from Visit 1(Baseline Visit) in Triglyceride at Visit 5(week 16)

  10. C-peptide

    Measured: Change from Visit 1(Baseline Visit) in C-peptide at Visit 5(week 16)

  11. Insulin

    Measured: Change from Visit 1(Baseline Visit) in insulin at Visit 5(week 16)

  12. hsCRP

    Measured: Change from Visit 1(Baseline Visit) in hsCRP at Visit 5(week 16)

  13. HOMA-β

    Measured: Change from Visit 1(Baseline Visit) in HOMA-β at Visit 5(week 16)

  14. HOMA-IR

    Measured: Change from Visit 1(Baseline Visit) in HOMA-IR at Visit 5(week 16)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2013 (estimated)
  2. Study startMay 2012
  3. Primary completionMay 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01805830
Sponsor's protocol ID
MP_C301
Acronym
T2DM
Status last verified
Oct 2015
First submitted
26 Dec 2012
Last updated
6 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MP513 in people with Type 2 Diabetes, run by Handok Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: Change from Visit 1(Baseline Visit) in HbA1c at Visit 5(week 16)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01805830.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.

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