Trials Sponsors Conditions Drugs Pricing

Conditions

Type 2 Diabetes Mellitus and Microalbuminuria

Keywords

Pharmacological therapy

Outcome Measures

Primary Outcomes (1)

Change From End of Pre-treatment Period (Week 0) in Log-transformed Urine Albumin/Creatinine Ratio (UACR) at the End of Treatment Period (Week 12)
The first morning void urine (the first urine immediately after rising prior to activities in standing position in the morning) samples on the day of each visit, and 1 day and 2 days before the day of each visit (3 consecutive days) were collected to calculate UACR.
Week 0 and Week 12

Secondary Outcomes (3)

Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point
Weeks 2, 4, 8, 12, follow-up (Week 14) and End of Treatment
Remission Rate From Early-Stage Nephropathy (Stage 2) to Pre-Nephropathy Stage (Stage 1) at the End of Treatment (Week 12)
Week 12
Progression Rate From Early-Stage Nephropathy (Stage 2) to Overt Nephropathy (Stage 3) During the Treatment Period (Week 12)
Week 12

Other Outcomes (1)

Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Up to Week 14

Study Arms (6)

Placebo

PLACEBO COMPARATOR

TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).

Drug: TAK-272 PlaceboDrug: Candesartan cilexetil Placebo

TAK-272 5 mg

EXPERIMENTAL

TAK-272 5 mg one tablet, TAK-272 placebo 3 tablets and Candesartan cilexetil placebo one tablet, orally, once daily for up to 12 weeks. Participants were administered TAK-272 placebo 4 tablets and Candesartan cilexetil placebo one tablet for 4 weeks (Week -4 to 0) in placebo run-in period and follow-up period (Week 12-14).

Drug: TAK-272Drug: TAK-272 PlaceboDrug: Candesartan cilexetil Placebo

Interventions

TAK-272Drug

TAK-272 tablets

TAK-272 20 mgTAK-272 40 mgTAK-272 5 mgTAK-272 80 mg

TAK-272 PlaceboDrug

TAK-272 placebo-matching tablets

Eligibility Criteria

Age20 Years - 74 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

In the opinion of the investigator or the sub-investigator, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.

Sponsors & Collaborators

Takeda
Industrylead

Study Sites (68)

Nagoya, Aichi-ken, Japan

Chiba, Chiba, Japan

Kisarazu-shi, Chiba, Japan

Fukuoka, Fukuoka, Japan

Fukutsu-shi, Fukuoka, Japan

Kitakyuushu-shi, Fukuoka, Japan

Kouriyama-shi, Fukushima, Japan

Anchu-shi, Gunma, Japan

Related Publications (1)

Wang GM, Li LJ, Fan L, Xu M, Tang WL, Wright JM. Renin inhibitors versus angiotensin receptor blockers for primary hypertension. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD012570. doi: 10.1002/14651858.CD012570.pub2.
PMID: 40013543DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

imarikiren hydrochloridecandesartan cilexetil

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title: Medical Director
Organization: Takeda

Study Officials

Medical Director Clinical Science
Takeda
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

415 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 26, 2014

First Posted

January 7, 2015

Study Start

October 16, 2014

Actual (reported)

You may not qualify if:

The participant received TAK-272 in a previous clinical study.
The participant 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 consent to participate under duress.
The participant has a history of hypersensitivity or allergies to TAK-272, candesartan cilexetil and other renin-angiotensin system (RAS) inhibitors (angiotensin converting enzyme \[ACE\] inhibitors, angiotensin II receptor blocker \[ARBs\] or direct renin inhibitor \[DRIs\]).
The participant needs to take the prohibited medications during the study period.
The participant has hyperkalemia (e.g., serum potassium ≥ 5.0 mEq/L at the start of the pretreatment period (Week -8) and Week -4 or requiring regular use of a potassium adsorbent) or onset of hyperkalemia within 2 years prior to starting the pre-treatment period.
The participant has at least class II hypertension (e.g., sitting systolic blood pressure \[SBP\] ≥160 mmHg or sitting diastolic blood pressure \[DBP\] ≥100 mmHg in the pre-treatment period) or malignant hypertension.
The participant has a renal disease other than type 2 diabetic nephropathy (e.g., patients with renal sclerosis, acute or chronic glomerular nephritis, or polycystic kidney).
The participant has bilateral or unilateral renal artery stenosis.
The participant 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 participant has a history of any of the cardiovascular diseases listed below within 2 years prior to starting the pre-treatment period:
Cardiac diseases: myocardial infarction, coronary arterial revascularization
Cerebrovascular diseases: cerebral infarction (excluding lacunar infarction), cerebral hemorrhage, transient ischemic attack
The participant has any of the cardiovascular diseases listed below:
Cardiac diseases: angina pectoris, arrhythmia, and congested heart failure that requires medication
Vascular diseases: arteriosclerosis obliterans with symptoms (e.g., intermittent claudication)
+16 more criteria

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (1)

Study Arms (6)

Placebo

TAK-272 5 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (68)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

TAK-272 20 mg

TAK-272 40 mg

TAK-272 80 mg

Candesartan cilexetil 8 mg

You may not qualify if:

Source record

Locations