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 extensio

• Conditions: Type 2 diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate control

• Registration Number: EUCTR2008-008732-84-HU
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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.

10. The subject is capable of giving informed consent, complying with the restrictions and requirements of the protocol and, in the opinion of the Investigator, will be able to complete the study.

Open Label Extension
1. Subjects who have completed the 24-week double-blind treatment period of the study and who have not met the withdrawal criteria.

2. Female subjects of child bearing potential must be using adequate methods of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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
loss)

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.

5. The screen for drugs of abuse is positive at the screening visit.

6. 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 20 mL of spirits).

7. The subject has a medical history of respiratory insufficiency, unstable angina or cardiac failure (New York Heart association class II-IV) or any clinically significant ECG abnormalities such as ventricular tachycardia or a medical history of ventricular tachycardia.

8. The subject has QTc prolongation > 470 ms, risk factors for Torsades de Points (cardiac insufficiency NYHA II -IV, hypokalaemia, family history of Long QT Syndrome) or subject is receiving co-medication with QT lengthening medications (Arizona CERT Lists No. 1 and 2 – Appendix 17.3).

9. 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).

10. The subject has received insulin within 12 months prior to the screening visit, with the exception of insulin therapy during hospitalisation, insulin therapy for medical conditions not requiring hospitalisation (<2 weeks’ duration) or use in gestational diabetes.

11. The subject is suffering from serious concurrent renal disease or has serum creatinine =1.5 mg/dL (males) or =1.4 mg/dL (females) at the screening visit, OR creatinine clearance <60 mL/min (calculated using Cockcroft
Gault equation).

12. 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 90 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.

13. Female subjects who are pregnant, lactating, or are planning to become pregnant during the study.

14. The subject is expected to require additional antidiabetic treatment for his/her Type 2 diabetes or its complications within the next 28 weeks at the screening visit, or within the next 24 weeks at Day -1.

15. The subject has a clinically significant liver disease with aspartate-amino-transferase (AST) and alanineamino-transferase (ALT) >2.5 times the upper limit of normal (ULN) at the screening visit.

16. The subject has d

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the trial is to assess the efficacy of MP-513 on glycemic control. ;Secondary Objective: The seconday objectives of the trial are to investigate the safety of MP-513 and to assess its efficacy on body weight and lipid profile.<br>;Primary end point(s): Comparison of change in HbA1c from baseline to week 24 for each active treatment group compared with the placebo group.