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

Type 2 Diabetes Mellitus Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT01798238
• Study type: Interventional
• Source: Handok Pharmaceuticals Co., Ltd.
• Status: Completed
• Phase: Phase 3
• Start date: November 2012
• Completion date: May 2014