A Phase IIb, double-blind, parallel group, multi-centre, dose-finding study to investigate the efficacy and safety of 4 doses of MP-513 when added to ongoing metformin monotherapy in subjects with Type 2 diabetes mellitus, with an open label extension

Mitsubishi Tanabe Pharma Corporation0 sites448 target enrollmentMay 5, 2009

Overview

No summary available.

Registry

who.int

Start Date

May 5, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Double\-Blind Treatment Period
•1\. A signed and dated informed consent form has been obtained from the subject, in accordance with ICH GCP, before any screening or study related procedures take place.
•2\. The subject is aged \=18 years at signature of the informed consent form.
•3\. The subject has had a documented diagnosis of Type 2 diabetes for at least 6 months at the screening visit.
•4\. The subject’s Type 2 diabetes is managed by metformin monotherapy \=1500 mg/day (or \= 1000 mg/day if this is the maximum tolerated dose), plus diet and exercise, as appropriate, and the dose has been unchanged for at least 56 consecutive days at the screening visit.
•5\. The subject’s HbA1c is \=7\.0 % and \< 10\.0% at the screening visit and Day \-15\.
•6\. The subject’s BMI is \=20\.0 and \=40\.0 kg/m2 at the screening visit and on Day \-1\.
•7\. The subject’s C\-peptide is positive (\> 0\.5 nmol/L) at the screening visit.
•8\. The subject’s FPG at screening visit and on Day \-15 is \<15 mmol/L.
•9\. Female subjects have a negative serum pregnancy test at the screening visit.

•Double\-Blind Treatment Period
•1\. 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, retinopathy or nephropathy.
•Symptoms of poor blood glucose control (polyuria, polydipsia or weight
•2\. The subject has a history of Type 1 diabetes or a secondary form of diabetes.
•3\. The subject has a history of allergy to MP\-513, or to any of the excipients in the MP\-513 tablet eg mannitol.
•4\. The subject has a history of drug abuse.