A placebo-controlled, double-blind, randomised study to evaluate the efficacy and safety of TAK-475 100mg in subjects with type 2 diabetes currently treated with lipid-lowering therapy.

Takeda Europe R &D Centre Ltd0 sites400 target enrollmentMay 17, 2006

Conditionstreatment of patients with primary dyslipidaemia MedDRA version: 8Level: ptClassification code 10058108

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: treatment of patients with primary dyslipidaemia
Sponsor: Takeda Europe R &D Centre Ltd
Enrollment: 400
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 17, 2006

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Takeda Europe R &D Centre Ltd

Eligibility Criteria

Inclusion Criteria

•\- Male and female subjects aged \= 18 years
•\- Capable of understanding and willing to sign the Informed Consent Form
•\- Documented diagnosis of Type 2 diabetes mellitus for \> 6 months (Random venous plasma glucose \= 200mg/dL (11\.1 mmol/L), 2\-hour glucose tolerance during a 75g oral glucose tolerance testing (OGTT) \= 200mg/dL or Fasting Plasma Glucose (FPG) \> 126 mg/dL (7 mmol/L)), with stable glycaemic control over a period of at least 3 month and Hb A1c of 9\.5 % or less
•\- On a stable antidiabetic regime, which may include oral antidiabetic medication and/or insulin, for at least 3 months prior to Screening (Visit 1\)
•\- The most recent value of LDL\-c \= 100 mg/dL (2\.59 mmol/L) and triglycerides \= 400 mg/dL (4\.52 mmol/L ), within the previous 6 months, currently treated with one of the following lipid\-lowering drugs: atorvastatin (10 mg, 20 mg, or 40 mg), simvastatin (20 mg or 40 mg), rosuvastatin (10 mg or 20 mg), or fenofibrate (not to exceed 200 mg daily), and no changes in the medication for at least 4 Weeks before Screening (Visit 1\). If no value is available, then confirm acceptability for enrolment from result on sample taken at screening visit 1\.
•\- The subject is otherwise in good health as determined by a physician (ie, via medical history and physical examination)
•\- At Randomisation (Visit 4\) in order to be randomised subjects must have fulfilled the above criteria and also have: Mean LDL\-cholesterol levels of \= 100 mg/dL (2\.59 mmol/L) and mean triglycerides level of \= 400 mg/dl (4\.52 mmol/L). The mean values will be calculated from measurements made at Week –2 (Visit 2\) and Week –1 (Visit 3\) for each subject. For LDL\-cholesterol the difference between the two individual values must not differ by more than 15% of the upper value. For triglycerides the upper value for either sample must be \=450 mg/dL (5\.1 mmol/L). If the inclusion range is not attained for either LDL\-c or triglycerides levels then the investigator will repeat these assessments at an additional Visit (Visit 3\.1\). If the LDL\-c and triglycerides level then fulfil the above criteria at two consecutive visits, at least 1 week apart, and the individual value at Visit 3\.1 compared to one individual value from Visit 2 or 3 does not differ by more than 15%, then the subject may enter the active phase of treatment with TAK\-475 100 mg or placebo
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•At Screening (Visit 1\) and at Randomisation (Visit 4\) or when specified below, the subjects must not be/have:
•\- Type 1 Diabetes Mellitus
•\- Between screening and randomisation:
•(i) ALT or AST level \> 1\.5 times the upper limit of normal (ULN)
•(ii) Serum creatinine \> 133 µmol/L (\>1\.5 mg/dL) or
•(iii) CPK \> 3 times the upper limit of normal (ULN).
•Active liver disease, gallbladder disease (with or without cholelthiasis) or jaundice .
•\- Positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or subject’s verbal report.
•\- Positive human immunodeficiency virus status or is taking retroviral medications, as determined by medical history and/or subject’s verbal report.
•\- Known hypersensitivity or history of adverse reaction to TAK\-475