- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01798238
Teneligliptin(MP-513) Versus Placebo in Type 2 Diabetes Mellitus
August 4, 2014 updated by: Handok Inc.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
142
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of
- Handok Pharmaceuticals CO. LTD
-
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Gangnam-Gu
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Seoul, Gangnam-Gu, Korea, Republic of
- Handok INC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo group
|
Pink film-coated tablet for oral administration, frequency and duration: 1 tablet/day
|
EXPERIMENTAL: MP-513 group
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form : Pink film-coated tablet for oral administration Dosage : 20mg/tablet frequency and duration: 1 tablet/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glycosylated hemoglobin
Time Frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean fasting plasma glucose
Time Frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Weight
Time Frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Glycosylated hemoglobin <7.0% subject percent
Time Frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Triglycerides
Time Frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Homeostatic model assessment of insulin Resistance
Time Frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Body mass index
Time Frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Low Density Lipoprotein
Time Frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Visit 1(Baseline Visit) vs Visit 7(week 24)
|
High Density Lipoprotein
Time Frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Cholesterol
Time Frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Connecting peptide
Time Frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Insulin
Time Frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Homeostatic model assessment of beta-cell function
Time Frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Glycosylated hemoglobin <6.5% subject percent
Time Frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Visit 1(Baseline Visit) vs Visit 7(week 24)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sungwoo Park, Kangbuk Samsung Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (ACTUAL)
May 1, 2014
Study Completion (ACTUAL)
May 1, 2014
Study Registration Dates
First Submitted
February 18, 2013
First Submitted That Met QC Criteria
February 22, 2013
First Posted (ESTIMATE)
February 25, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
August 5, 2014
Last Update Submitted That Met QC Criteria
August 4, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP_C302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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