Type 2 diabetes mellitus and microalbuminuria
Conditions
Interventions
investigational material(s)
Generic name etc : TAK-272
INN of investigational material :
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigational material : T
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements -The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. -The subject is either male or female and aged >= 20 to < 75 years at the time of consent. -The subject is an early-stage nephropathy (Stage 2) patient with type 2 diabetes mellitus -The subject is a patient with type 2 diabetes mellitus on a certain diet therapy and/or exercise therapy (if any) -The subject's blood glucose, blood pressure and lipid are stably controlled, and drug changes or dose changes of therapeutic drugs for hypertension, therapeutic drugs for diabetes mellitus, therapeutic drugs for dyslipidemia or hyperlipidemia are not required throughout the study period as judged by the investigator -A male subject who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose. -A female subject of childbearing potential who is sexually active with a nonsterilized male partner who agrees to routinely use adequate contraception from signing of informed consent until 1 month after the completion of the study.
Exclusion criteria
Exclusion criteria: -The subject has received TAK-272 in a previous clinical study -The subject is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may have given consent to participate under duress. -The subject has a history of hypersensitivity or allergies to TAK-272, candesartan cilexetil and other RAS inhibitors (ACE inhibitors, ARBs or DRIs) -The subject needs to take the prohibited medications during the study period -The subject has hyperkalemia (e.g. serum potassium >= 5.0 mEq/L at Week -8 and -4 in the pre-treatment period, or requiring regular use of a potassium adsorbent) or onset of hyperkalemia within 2 years prior to starting the pre-treatment period -The subject has a renal disease other than type 2 diabetic nephropathy (e.g. patients with renal sclerosis, acute or chronic glomerular nephritis, or polycystic nephropathy). -The subject has bilateral or unilateral renal artery stenosis -The subject requires regular use of nonsteroidal anti-inflammatory drugs (excluding low-dose aspirin and locally-acting agents such as topical drugs) (e.g. rheumatoid arthritis patients, osteoarthritis patients, and low back pain patients) -The subject has a history of any of the cardiovascular diseases listed below within 2 years prior to starting the pre-treatment period: Heart diseases: myocardial infarction, coronary arterial revascularization Cerebrovascular diseases: cerebral infarction (excluding lacunar infarction), cerebral hemorrhage, transient ischemic attack -The subject has any of the cardiovascular diseases listed below: Heart diseases: angina pectoris, arrhythmia, and congested heart failure that requires medication Vascular diseases: arteriosclerosis obliterans with symptoms e.g. intermittent claudication -The subject has a clinically significant hepatic disorder (e.g. either of ALT or AST is >= 2.5 times the upper limit of normal at starting the pre-treatment period (Week -8) or at Week -4 in the pre-treatment period) -The subject has a complication of malignant tumor -If female, the subject is pregnant or lactating, or is planning to become pregnant or donate her ova before signing the informed consent form, during the study period, or within 1 month after the end of the study. -If male, the subject intends to donate sperm during the course of this study or for 12 weeks thereafter. -The subject is judged by the investigator as being ineligible for any other reason -The subject joined another clinical trial or post-marketing study within 30 days prior to starting the pre-treatment period -The subject was administered the study drug within 12 weeks prior to starting the pre-treatment period -The subject has a history of drug abuse (defined as the use of an illegal drug) or alcohol dependency within 2 years prior to starting the pre-treatment period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Log-transformed urine albumin/creatinine ratio change from completion of the pre-treatment period (Week 0) in the completion of the treatment period Primary timeframe: From completion of the pre-treatment period (Week 0) to completion of the treatment period Log-transformed urine albumin/creatinine ratio change from completion of the pre-treatment period (Week 0) in the completion of the treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| -urine albumin/creatinine ratio at each assessment point; -remission rate from early-stage nephropathy (Stage 2) to pre-nephropathy stage (Stage 1) at completion of the treatment period; -Progression rate from early-stage nephropathy (Stage 2) to overt nephropathy stage (Stage 3) during the treatment period -Safety [adverse events] Secondary timeframe: At the completion of the treatment period -urine albumin/creatinine ratio at each assessment point; -remission rate from early-stage nephropathy (Stage 2) to pre-nephropathy stage (Stage 1) at completion of the treatment period; -Progression rate from early-stage nephropathy (Stage 2) to overt nephropathy stage (Stage 3) during the treatment period -Safety [adverse events]:The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness, and causal relationship to TAK-272/candesartan cilexetil. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, reported from the first dose to the last dose of TAK-272/candesartan cilexetil. Among these, events which are considered possibly related to TAK-272/candesartan cilexetil are defined as adverse drug reactions. | — |
Outcome results
None listed