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Type 2 Diabetes Mellitus and MicroalbuminuriaPhase 2NCT02332824

A Phase 2 Dose-finding Study of TAK-272 in Participants With Type 2 Diabetes Mellitus and Microalbuminuria

A Phase 2 study testing TAK-272 and Candesartan cilexetil in people with Type 2 Diabetes Mellitus and Microalbuminuria, run by Takeda at 68 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test the efficacy and safety on daily oral doses of TAK-272 5 mg, 20 mg, 40 mg and 80 mg in patients with type 2 diabetes mellitus and microalbuminuria by randomized, double-blind, placebo-controlled, parallel-group comparison in order to determine the clinical dose of TAK-272. Read more about this study

Who is it for?
Ages 20 to 74 years
What is being tested?
TAK-272 and Candesartan cilexetil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
415 participants
Where
68 sitesJapan
Study dates
16 Oct 2014to 18 Aug 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • The participant is either male or female and aged 20 to less than 75 years at signing of informed consent.
  • The participant is an early-stage nephropathy (Stage 2) patient with type 2 diabetes mellitus.
  • Inpatient/outpatient: outpatient
  • The participant is a patient with type 2 diabetes mellitus on a certain diet therapy and/or exercise therapy (if any).
Show all 11Show fewer
  • The participant has stability controlled blood glucose, blood pressure and lipid, and does not need any change in the drug and the dose of any antihypertensive, antidiabetic and antidyslipidemia or antihyperlipidemic drugs throughout the study period as judged by the investigator or the sub-investigator.
  • The participant has urine albumin/creatinine ratio (UACR) of the first morning urine (the first urine immediately after rising prior to activities in standing position in the morning) is ≥30 to <300 mg/gCr on at least two of three measurements at the start of the pre-treatment period (Week -8), at Week -4 or Week -2.
  • The participant has estimated glomerular filtration rate according to creatinine (eGFRcreat) ≥45 mL/min/1.73 m^2 at Week -4.
  • A male participant 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 study period and for 12 weeks after the completion of the study.
  • A female participant 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.

Who cannot join

  • <Exclusion Criteria in whole pre-treatment period>
  • 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.
Show all 35Show fewer
  • 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)
  • The participant has a clinically significant hepatic disorder (e.g., either of alanine aminotransferase [ALT] or aspartate aminotransferase [AST] is ≥ 2.5 times the upper limit of normal at the start of the pre-treatment period (Week -8) or at Week -4).
  • The participant has a complication of malignant tumor.
  • If female, the participant is pregnant, lactating, or is intending to become pregnant before, during or within 1 month after participating in this study; or intending to donate ova during such time period.
  • If male, the participant intends to donate sperm during the course of this study or for 12 weeks thereafter.
  • The participant is judged by the investigator or the sub-investigator as being ineligible for any other reason.
  • <Exclusion Criteria at the start of the pre-treatment period (Week -8)>
  • The participant has participated in another clinical study or post-marketing study within 30 days prior to starting the pre-treatment period.
  • The participant has received the study medication within 12 weeks prior to starting the pre-treatment period.
  • The participant has a history of drug abuse (defined as the use of an illicit drug) or history of alcohol abuse within 2 years prior to starting the pre-treatment period.
  • The participant has changed the renin angiotensin system (RAS) inhibitor (angiotensin-converting enzyme [ACE] inhibitor, angiotensin II receptor blocker [ARB] or direct renin inhibitors [DRI]) or its dose and regimen within 12 weeks prior to starting the pre-treatment period.
  • The participant is treated with any RAS inhibitor (ACE inhibitor, ARB or DRI) at signing of informed consent, and whose UACR is <30 mg/gCr at the start of the pre-treatment period (Week -8).
  • <Exclusion Criteria at Week -4>
  • The participant has hemoglobin A1c (HbA1c) (National Glycohemoglobin Standardization Program [NGSP]) ≥9.0% at Week -4.
  • The participant has change in HbA1c (NGSP) from the start of the pre-treatment period (Week -8) to Week -4 by ≥10.0%* compared to the higher value of them.
  • Second decimal place to be rounded off <Exclusion Criteria at the end of the Pre-treatment period (Week 0)>
  • The participant's sitting SBP and sitting DBP changed by ≥20 mmHg or ≥10 mmHg, respectively, at the end of the pre-treatment period (Week 0) compared to Week -2.
  • The participant's sitting SBP is <130 mmHg at the end of the pre-treatment period (Week 0).
  • The participant's study drug compliance rate* during the pre-treatment period is <80.0%.
  • Compliance rate (%)=(Prescribed amount-Retrieved amount)/ {(Completion date of study drug for the pre-treatment period-Starting date of study drug for the pre-treatment period+1)×5}×100, second decimal place to be rounded off.

Trial locations and contacts

68 sites in 1 country.

68 sites in 1 country

Japan68 sites

  • Study site

    Anchu-shi, Gunma

  • Study site

    Azumino-shi, Nagano

  • Study site

    Chiba, Chiba

  • Study site

    Chiyoda-ku, Tokyo

  • Study site

    Chuo-ku, Tokyo

  • Study site

    Ebina-shi, Kanagawa

  • Study site

    Fukuoka, Fukuoka

  • Study site

    Fukutsu-shi, Fukuoka

  • Study site

    Hachioji-shi, Tokyo

  • Study site

    Hamamatsu, Shizuoka

  • Study site

    Hino-shi, Tokyo

  • Study site

    Hiratsuka-shi, Kanagawa

  • Study site

    Ishikari-shi, Hokkaido

  • Study site

    Itabashi-ku, Tokyo

  • Study site

    Kasaoka-shi, Okayama-ken

  • Study site

    Kashiwara-shi, Osaka

  • Study site

    Katsushika-ku, Tokyo

  • Study site

    Kawagoe-shi, Saitama

  • Study site

    Kawasaki-shi, Kanagawa

  • Study site

    Kisarazu-shi, Chiba

  • Study site

    Kitakyuushu-shi, Fukuoka

  • Study site

    Kobe, Hyōgo

  • Study site

    Kochi, Kochi

  • Study site

    Koga, Ibarakgi

  • Study site

    Koga-shi, Ibaraki

  • Study site

    Kouriyama-shi, Fukushima

  • Study site

    Koyama-shi, Tochigi

  • Study site

    Kumamoto, Kumamoto

  • Study site

    Kurashiki-shi, Okayama-ken

  • Study site

    Kyoto, Kyoto

  • Study site

    Kyuki-shi, Saitama

  • Study site

    Matsubara-shi, Osaka

  • Study site

    Matsumoto-shi, Nagano

  • Study site

    Mito, Ibaraki

  • Study site

    Miura-shi, Kanagawa

  • Study site

    Miyazaki, Miyazaki

  • Study site

    Moriya-shi, Ibaragi

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Naha, Okinawa

  • Study site

    Naka, Ibaragi

  • Study site

    Nakano-shi, Nagano

  • Study site

    Nerima-ku, Tokyo

  • Study site

    Neyagawa, Osaka

  • Study site

    Nishinomiya-shi, Hyōgo

  • Study site

    Obihiro-shi, Hokkaido

  • Study site

    Osaka, Osaka

  • Study site

    Ōta-ku, Tokyo

  • Study site

    Ota-shi, Gunma

  • Study site

    Saitama-shi, Saitama

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sasebo-shi, Nagasaki

  • Study site

    Sendai, Miyagi

  • Study site

    Shibuya-ku, Tokyo

  • Study site

    Shimajiri-gun, Okinawa

  • Study site

    Shimono-shi, Tochigi

  • Study site

    Shinagawa-ku, Tokyo

  • Study site

    Shinjuku-ku, Tokyo

  • Study site

    Shinjyuku-ku, Tokyo

  • Study site

    Shizuoka, Shizuoka

  • Study site

    Shounann-shi, Kanagawa

  • Study site

    Suita-shi, Osaka

  • Study site

    Takamatsu, Kagawa-ken

  • Study site

    Tomigusuku-shi, Okinawa

  • Study site

    Tondabayashi-shi, Osaka

  • Study site

    Ube-shi, Yamaguchi

  • Study site

    Uji-shi, Kyoto

  • Study site

    Yatsushiro-shi, Kumamoto

  • Study site

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison, Phase 2 Study to Evaluate the Dose-response Relationship of the Efficacy and Safety of Oral Administration of TAK-272 in Patients With Type 2 Diabetes Mellitus and Microalbuminuria

The purpose of this study is to test the efficacy and safety on daily oral doses of TAK-272 5 mg, 20 mg, 40 mg and 80 mg in patients with type 2 diabetes mellitus and microalbuminuria by randomized, double-blind, placebo-controlled, parallel-group comparison in order to determine the clinical dose of TAK-272.

Read the detailed description

The drug being tested in this study is called TAK-272. This study evaluated the dose-response relationship of the efficacy and safety of TAK-272 in participants with type 2 diabetes mellitus and microalbuminuria.

The study enrolled 415 patients. Participants were randomly assigned to one of the 6 treatment groups:

  • TAK-272 5 mg
  • TAK-272 20 mg
  • TAK-272 40 mg
  • TAK-272 80 mg
  • Candesartan cilexetil 8 mg
  • Placebo (dummy inactive pill) for TAK-272 or Candesartan cilexetil - this was a tablet that looks like the study drug but had no active ingredient

All participants were administered tablets, orally at the same time each day for 12 weeks in double-blind manner. 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).

This multi-center trial was conducted in Japan. The overall time to participate in this study is 22 weeks including 2 weeks of follow-up assessment period after last dose of study drug. Participants made multiple visits to the clinic during these periods.

Being tested
TAK-272, TAK-272 Placebo, Candesartan cilexetil, Candesartan cilexetil Placebo
Keywords
Pharmacological therapy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-272Drug

    TAK-272 tablets

  • TAK-272 PlaceboDrug

    TAK-272 placebo-matching tablets

  • Candesartan cilexetilDrug

    Candesartan cilexetil tablets

  • Candesartan cilexetil PlaceboDrug

    Candesartan cilexetil placebo-matching tablets

Study groups in NCT02332824
Study groupRoleWhat they receive
PlaceboPlacebo comparatorTAK-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).
Receives: Drug: TAK-272 Placebo; Drug: Candesartan cilexetil Placebo
TAK-272 5 mgExperimentalTAK-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).
Receives: Drug: TAK-272; Drug: TAK-272 Placebo; Drug: Candesartan cilexetil Placebo
TAK-272 20 mgExperimentalTAK-272 20 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).
Receives: Drug: TAK-272; Drug: TAK-272 Placebo; Drug: Candesartan cilexetil Placebo
TAK-272 40 mgExperimentalTAK-272 20 mg 2 tablets, TAK-272 placebo 2 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).
Receives: Drug: TAK-272; Drug: TAK-272 Placebo; Drug: Candesartan cilexetil Placebo
TAK-272 80 mgExperimentalTAK-272 20 mg 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).
Receives: Drug: TAK-272; Drug: Candesartan cilexetil Placebo
Candesartan cilexetil 8 mgActive comparatorTAK-272 placebo 4 tablets and Candesartan cilexetil 8 mg 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).
Receives: Drug: TAK-272 Placebo; Drug: Candesartan cilexetil

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 0 and Week 12

Secondary outcomes (3)

  1. Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point

    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. Reported data is geometric mean ratio of UACR at each assessment point relative to Baseline.

    Measured: Weeks 2, 4, 8, 12, follow-up (Week 14) and End of Treatment

  2. Remission Rate From Early-Stage Nephropathy (Stage 2) to Pre-Nephropathy Stage (Stage 1) at the End of Treatment (Week 12)

    Remission rate is defined as percentage of participants who have UACR <30 mg/gCr and whose UACR decreased by ≥30% from the value at the end of the pre-treatment period (Week 0).

    Measured: Week 12

  3. Progression Rate From Early-Stage Nephropathy (Stage 2) to Overt Nephropathy (Stage 3) During the Treatment Period (Week 12)

    Progression rate is defined as percentage of participants who have UACR ≥300 mg/gCr and whose UACR increased by ≥30% from the value at the end of the pre-treatment period [Week 0]. Meanwhile, the definition of transition to overt nephropathy also includes the case that UACR decreased to <300 mg/gCr after the transition to overt nephropathy.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2015 (estimated)
  2. Study start16 Oct 2014
  3. Primary completion18 Aug 2016
  4. Study completion18 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02332824
Sponsor's protocol ID
TAK-272/CCT-101
Other IDs
JapicCTI-142658, U1111-1161-6858
Status last verified
Nov 2017
First submitted
26 Sep 2014
Last updated
13 Aug 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40013543

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAK-272 and Candesartan cilexetil in people with Type 2 Diabetes Mellitus and Microalbuminuria, run by Takeda at 68 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Week 0 and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02332824, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.

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