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

NCT01805830 | Completed Phase 3

• 1 other identifier: MP_C301
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes

Keywords

Type2DM / DPP-IV inhibitors

Outcome Measures

Primary Outcomes (1)

• HbA1c

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

Secondary Outcomes (14)

• FPG(Fasting Plasma Glucose)

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

• Weight

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

• BMI

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

• HbA1c <7.0%

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

• HbA1c <6.5%

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

Study Arms (2)

MP513 group

EXPERIMENTAL

Drug: MP513

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MP513 DRUG

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

MP513 group

Placebo DRUG

form : Pink film-coated tablet for oral administration Dosage : 20mg/tablet 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 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Handok Inc.: lead

Study Sites (1)

Handok Pharmaceuticals CO. LTD

Seoul, 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

• BONGYUN CHA

  Seoul St. Mary's 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: December 26, 2012
• First Posted: March 6, 2013
• Study Start: May 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

KR (1)