Type 2 diabetes mellitus MedDRA version: 13.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: MP-513
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: MP-513
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of
Sponsors
Mitsubishi Tanabe Pharma Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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 0.5 nmol/L) at the screening visit. 8. The subject’s FPG at screening visit and on Day -15 is =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Double-Blind 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). Any subject randomised prior to approval of Amendment 2 in their country, and who is receiving co-medication with QT-lengthening medications (Arizona CERT Lists No. 1 and 2), will be allowed to continue in the Double-Blind Treatment Period, provided they do not meet any of the withdrawal criteria listed in section 9.1. 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 be
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;Primary end point(s): Comparison of change in HbA1c from baseline to week 24 for each active treatment group compared with the placebo group. ;Timepoint(s) of evaluation of this end point: The primary endpoint analysis will be performed after all patients have completed the double blind phase of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): i. Comparison of change in mean FPG from baseline to weeks 12 and 24 for each active group compared with the placebo group. ii. Comparison of change in mean HbA1c from baseline to weeks 12 for each active treatment group compared with the placebo group. iii. Comparison of change in mean blood glucose before meals from baseline to weeks 12 and 24 for each active treatment group compared with the placebo group. iv. Comparison of change in body weight and BMI from baseline to weeks 12 and 24, for each active treatment group compared with the placebo group. v. Percentage of subjects from each treatment group who achieve HbA1c < 7.0% and < 6.5%. vi. Comparison of absolute change in serum lipids (total cholesterol, LDL-and HDL-cholesterol, triglycerides and free fatty acids) and apolipoproteins A1 and B (including Apo B/ApoA1 ratio) from baseline to weeks 12 and 24 for each active treatment group compared with the placebo group. vii. Comparison of percentage change in serum lipids (total cholesterol, LDL and HDL cholesterol, triglycerides) and apolipoproteins A1 and B (including Apo B/ApoA1 ratio) from baseline to weeks 12 and 24 for each active treatment group compared with the placebo group. viii. Comparison of change in C-peptide, insulin, CRP, glucagon, HOMA-b, and HOMA-IR from baseline to weeks 12 and 24 for each active treatment group compared with the placebo group.;Timepoint(s) of evaluation of this end point: The secondary endpoint analysis will be performed after all patients have completed the double blind phase of the study. | — |
Countries
Denmark, Germany, Hungary, Lithuania, United Kingdom
Contacts
Public ContactThe Regulatory Group, R&D Services
Mitsubishi Pharma Europe Ltd
Outcome results
None listed