Efficacy and Safety of MP-513 in Combination With Metformin in Patients With Type 2 Diabetes
Summary
The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Metformin with an extension treatment for up to 52 weeks.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Type 2 Diabetes Mellitus
Intervention
MP-513 Lowest Dose and Metformin, MP-513 Low Dose and Metformin, MP-513 Medium Dose and Metformin, MP-513 High Dose and Metformin, Placebo and Metformin
Location
Aalborg
Denmark
Status
Active, not recruiting
Source
Mitsubishi Tanabe Pharma Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00971243
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Metformin
A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
Lethal Dose 50
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
Maximum Tolerated Dose
The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)
Dose Fractionation
Administration of the total dose of radiation (RADIATION DOSAGE) in parts, at timed intervals.
Radiotherapy, Conformal
Radiotherapy where there is improved dose homogeneity within the tumor and reduced dosage to uninvolved structures. The precise shaping of dose distribution is achieved via the use of computer-controlled multileaf collimators.
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