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Type 2 Diabetes MellitusPhase 3NCT01798238

Teneligliptin(MP-513) Versus Placebo in Type 2 Diabetes Mellitus

A Phase 3 study testing MP-513 in people with Type 2 Diabetes Mellitus, run by Handok Inc. at 2 sites 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 Mellitus
What is being tested?
MP-513
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
142 participants
Where
2 sitesSouth Korea
Study dates
Nov 2012to May 2014
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 informed consent form
  • The subject has a documented diagnosis of Type 2 diabetes
  • The subject's HbA1c is 7.0%≤HbA1c<10.0% at screening visit and run-in visit
  • The subject's BMI is 20.0≤BMI≤40.0kg/m2
  • The subject's fasting plasma glucose is <15 mmol/L (270 mg/dL)at screening visit and run-in visit
  • The subject conducts a proper diet and exercise therapy for diabetes and its contents have not been changed for at least 8 week(56 days) at run-in visit(this does not apply to a subject with complications as as result of that exercise therapy is impossible)
  • The subject has not used other diabetic medicine for at least 8 week(56 days) at run-in visit
  • The subject is capable of giving informed consent, complying with the restrictions and requirements of the protocol

Who cannot join

  • The subject has a history of Type 1 diabetes or a secondary form of diabetes(Diabetes caused by the pancreatic diseases, such as chronic pancreatitis, pancreatic cancer, hemochromatosis or the overproduction of hormones antagonistic to insulin, Cushing's syndrome, Basedow's disease, pheochromocytoma, drug, insulin receptor abnormalities)
  • The subject has a history of MP-513 treatment
  • The subject has a history of habitual and excessive alcohol abuse or drug abuse, or concerns
  • 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 administration of an unlicensed medicinal product within 12 weeks prior to the screening visit or is participating any other clinical study
  • 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
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  • Female subjects whose pregnancy test is positive or who are pregnant, lactating, or are planning to become pregnant during the study
  • The subject has serum creatinine >1.5 mg/dL(male) or >1.4 mg/dL(female)
  • The subject has aspartate-amino-transferase (AST) and alanine-amino-transferase (ALT) >2.5 times the upper limit of normal (ULN)
  • The subject has diastolic blood pressure >100 mmHg and/or systolic blood pressure >180 mmHg
  • 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

2 sites in 1 country.

South Korea2 sites

  • Handok INC

    Seoul, Gangnam-Gu

  • Handok Pharmaceuticals CO. LTD

    Seoul

Other trials in South Korea

About this study

Official title: A Phase III Double-blind, Parallel Group, Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of MP-513 Monotherapy in Patients With Type 2 Diabetes Mellitus

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.
  • In many countries, the most commonly prescribed primary oral diabetes drug that does not cause hypoglycemia or weight gain, is metformin, but metformin can cause gastrointestinal adverse drug reactions, nausea, vomiting, diarrhea, abdominal pain and loss of appetite and other symptoms, and rare but life-threatening lactic acidosis.
  • This decrease in the Power of Hydrogen Ions of the blood (<7.25) and the increase in blood lactate (> 5 mmol / L) is associated with a reduced kidney failure and if there is kidney impairment, decreased metformin clearance and thus accumulated metformin may occur lactic acidosis more frequently. Also there is inconvenience, such as adjusting metformin dose depending on patient's condition.
  • MP-513 is expected to be safely used as a treatment for type 2 diabetes because it has no risk of hypoglycemia and/or weight gain which are reported in pre-existing diabetes therapies and no inconvenience related to dose adjustment depending on patient's condition, and no cases of fatal side effects.
  • Furthermore the inhibitory effect on Dipeptidyl peptidase-IV was stronger and half-life was longer compared with other dipeptidyl peptidase-IV inhibitors in non-clinical trial, and blood glucose moderating effects are proven to be clinically significant in clinical trials conducted in Europe and Japan in that its development as a therapeutic agent for patients with type 2 diabetes is considered to be promising.
  • Based on these previous studies, the objective of this study is to investigate the efficacy and safety in subjects with type 2 diabetes mellitus that is not adequately controlled with exercise and diet.
Being tested
MP-513, Placebo
Keywords
Type 2 Diabetes Mellitus / Dipeptidyl peptidase-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.

  • MP-513Drug

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

  • PlaceboDrug

    Pink film-coated tablet for oral administration, frequency and duration: 1 tablet/day

Study groups in NCT01798238
Study groupRoleWhat they receive
Placebo groupPlacebo comparatorNot described
Receives: Drug: Placebo
MP-513 groupExperimentalNot described
Receives: Drug: MP-513

What is being measured

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

  1. Glycosylated hemoglobin

    Measured: Visit 1(Baseline Visit) vs Visit 7(week 24)

Secondary outcomes (13)

  1. Mean fasting plasma glucose

    Measured: Visit 1(Baseline Visit) vs Visit 7(week 24)

  2. Weight

    Measured: Visit 1(Baseline Visit) vs Visit 7(week 24)

  3. Glycosylated hemoglobin <7.0% subject percent

    Measured: Visit 1(Baseline Visit) vs Visit 7(week 24)

  4. Triglycerides

    Measured: Visit 1(Baseline Visit) vs Visit 7(week 24)

  5. Homeostatic model assessment of insulin Resistance

    Measured: Visit 1(Baseline Visit) vs Visit 7(week 24)

  6. Body mass index

    Measured: Visit 1(Baseline Visit) vs Visit 7(week 24)

  7. Low Density Lipoprotein

    Measured: Visit 1(Baseline Visit) vs Visit 7(week 24)

  8. High Density Lipoprotein

    Measured: Visit 1(Baseline Visit) vs Visit 7(week 24)

  9. Cholesterol

    Measured: Visit 1(Baseline Visit) vs Visit 7(week 24)

  10. Connecting peptide

    Measured: Visit 1(Baseline Visit) vs Visit 7(week 24)

  11. Insulin

    Measured: Visit 1(Baseline Visit) vs Visit 7(week 24)

  12. Homeostatic model assessment of beta-cell function

    Measured: Visit 1(Baseline Visit) vs Visit 7(week 24)

  13. Glycosylated hemoglobin <6.5% subject percent

    Measured: Visit 1(Baseline Visit) vs Visit 7(week 24)

Timeline

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

  1. First posted25 Feb 2013 (estimated)
  2. Study startNov 2012
  3. Primary completionMay 2014
  4. Study completionMay 2014

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
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01798238
Sponsor's protocol ID
MP_C302
Status last verified
Aug 2014
First submitted
18 Feb 2013
Last updated
5 Aug 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MP-513 in people with Type 2 Diabetes Mellitus, run by Handok Inc. at 2 sites 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 8 inclusion and 11 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 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Glycosylated hemoglobin (time frame: Visit 1(Baseline Visit) vs Visit 7(week 24)). 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 NCT01798238.

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 5 Aug 2014.

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