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

NCT01798238 | Completed Phase 3

• 1 other identifier: MP_C302
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus / Dipeptidyl peptidase-IV inhibitors

Outcome Measures

Primary Outcomes (1)

• Glycosylated hemoglobin

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

Secondary Outcomes (13)

• Mean fasting plasma glucose

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

• Weight

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

• Glycosylated hemoglobin <7.0% subject percent

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

• Triglycerides

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

• Homeostatic model assessment of insulin Resistance

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

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

MP-513 group

EXPERIMENTAL

Drug: MP-513

Interventions

MP-513 DRUG

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

MP-513 group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Handok Inc.: lead

Study Sites (2)

Handok INC

Seoul, Gangnam-Gu, South Korea

Location

Handok Pharmaceuticals CO. LTD

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sungwoo Park

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 25, 2013
• Study Start: November 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 5, 2014

Record last verified: 2014-08

Locations

KR (2)