NCT01805830

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Handok Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Interventions

Type	Name	Description
DRUG	MP513	form : Pink film-coated tablet for oral administration Dosage : 20mg/tablet frequency and duration: 1 tablet/day
DRUG	Placebo	form : Pink film-coated tablet for oral administration Dosage : 20mg/tablet frequency and duration: 1 tablet/day

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-05-01
• Completion: 2013-09-01
• First posted: 2013-03-06
• Last updated: 2015-10-06

Locations

1 site across 1 country: South Korea