Type 2 Diabetes Mellitus and Microalbuminuria
Conditions
Keywords
Pharmacological therapy
Brief 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.
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.
Interventions
DRUGCandesartan cilexetil
Candesartan cilexetil tablets
DRUGTAK-272
TAK-272 tablets
DRUGTAK-272 Placebo
TAK-272 placebo-matching tablets
DRUGCandesartan cilexetil Placebo
Candesartan cilexetil placebo-matching tablets
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* 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). * 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.
Exclusion criteria
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Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Week 0 and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Weeks 2, 4, 8, 12, follow-up (Week 14) and End of Treatment | 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. |
| Remission Rate From Early-Stage Nephropathy (Stage 2) to Pre-Nephropathy Stage (Stage 1) at the End of Treatment (Week 12) | 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). |
| Progression Rate From Early-Stage Nephropathy (Stage 2) to Overt Nephropathy (Stage 3) During the Treatment Period (Week 12) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | Up to Week 14 | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 81 investigative sites in Japan from 16 Oct 2014 to 18 Aug 2016.
Pre-assignment details
Participants with a diagnosis of type 2 diabetes mellitus and microalbuminuria (early-stage nephropathy \[Stage 2\] patients with type 2 diabetes mellitus) were randomized in 1:1:1:1:1:1 to either of TAK-272 5 mg, 20 mg, 40 mg, 80 mg, candesartan cilexetil 8 mg or Placebo and administered tablets orally once daily for 12 weeks in double-blind manner.
Participants by arm
| Arm | Count |
|---|---|
| Placebo 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). | 67 |
| TAK-272 5 mg 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). | 67 |
| TAK-272 20 mg TAK-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). | 74 |
| TAK-272 40 mg TAK-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). | 68 |
| TAK-272 80 mg TAK-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). | 69 |
| Candesartan Cilexetil 8 mg Candesartan cilexetil 8 mg, one tablet, and TAK-272 placebo 4 tablets, 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). | 70 |
| Total | 415 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Inconvenient schedule | 1 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Pretreatment Event/Adverse Event | 4 | 0 | 1 | 1 | 4 | 1 |
| Overall Study | Transfer | 0 | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Voluntary Withdrawal | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | TAK-272 20 mg | Total | Candesartan Cilexetil 8 mg | TAK-272 5 mg | TAK-272 80 mg | Placebo | TAK-272 40 mg |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 9.57 | 61.3 years STANDARD_DEVIATION 9.4 | 62.4 years STANDARD_DEVIATION 9.29 | 61.8 years STANDARD_DEVIATION 8.9 | 61.2 years STANDARD_DEVIATION 9.95 | 62.2 years STANDARD_DEVIATION 8.38 | 59.6 years STANDARD_DEVIATION 10.22 |
| Body Mass Index (BMI) | 26.91 kg/m^2 STANDARD_DEVIATION 5.035 | 26.45 kg/m^2 STANDARD_DEVIATION 4.518 | 26.60 kg/m^2 STANDARD_DEVIATION 5.483 | 26.41 kg/m^2 STANDARD_DEVIATION 4.208 | 26.41 kg/m^2 STANDARD_DEVIATION 3.543 | 25.93 kg/m^2 STANDARD_DEVIATION 4.024 | 26.39 kg/m^2 STANDARD_DEVIATION 4.58 |
| Concurrent Medical Condition Dyslipidemia - No | 16 Participants | 118 Participants | 24 Participants | 26 Participants | 13 Participants | 22 Participants | 17 Participants |
| Concurrent Medical Condition Dyslipidemia - Yes | 58 Participants | 297 Participants | 46 Participants | 41 Participants | 56 Participants | 45 Participants | 51 Participants |
| Concurrent Medical Condition Hypertension - No | 14 Participants | 99 Participants | 18 Participants | 21 Participants | 9 Participants | 17 Participants | 20 Participants |
| Concurrent Medical Condition Hypertension - Yes | 60 Participants | 316 Participants | 52 Participants | 46 Participants | 60 Participants | 50 Participants | 48 Participants |
| Duration of Type 2 Diabetes Mellitus | 11.06 years STANDARD_DEVIATION 7.708 | 11.19 years STANDARD_DEVIATION 7.45 | 10.38 years STANDARD_DEVIATION 7.046 | 11.48 years STANDARD_DEVIATION 7.355 | 10.88 years STANDARD_DEVIATION 7.363 | 12.24 years STANDARD_DEVIATION 8.164 | 11.19 years STANDARD_DEVIATION 7.151 |
| eGFRcreat | 79.19 mL/min/1.73m^2 STANDARD_DEVIATION 19.449 | 79.97 mL/min/1.73m^2 STANDARD_DEVIATION 19.98 | 83.27 mL/min/1.73m^2 STANDARD_DEVIATION 22.777 | 81.81 mL/min/1.73m^2 STANDARD_DEVIATION 19.788 | 77.81 mL/min/1.73m^2 STANDARD_DEVIATION 18.425 | 77.17 mL/min/1.73m^2 STANDARD_DEVIATION 18.828 | 80.51 mL/min/1.73m^2 STANDARD_DEVIATION 20.292 |
| Haemoglobin A1c (HbA1c) | 7.06 percentage of glycated haemoglobin STANDARD_DEVIATION 0.77 | 7.01 percentage of glycated haemoglobin STANDARD_DEVIATION 0.778 | 7.02 percentage of glycated haemoglobin STANDARD_DEVIATION 0.731 | 7.03 percentage of glycated haemoglobin STANDARD_DEVIATION 0.772 | 6.90 percentage of glycated haemoglobin STANDARD_DEVIATION 0.834 | 7.02 percentage of glycated haemoglobin STANDARD_DEVIATION 0.789 | 7.03 percentage of glycated haemoglobin STANDARD_DEVIATION 0.789 |
| Previous Medication Potassium-Sparing Diuretic - No | 74 Participants | 412 Participants | 69 Participants | 66 Participants | 69 Participants | 67 Participants | 67 Participants |
| Previous Medication Potassium-Sparing Diuretic - Yes | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Previous Medication RAS Inhibitor - No | 41 Participants | 225 Participants | 35 Participants | 36 Participants | 33 Participants | 37 Participants | 43 Participants |
| Previous Medication Renin-angiotensin system (RAS) Inhibitor - Yes | 33 Participants | 190 Participants | 35 Participants | 31 Participants | 36 Participants | 30 Participants | 25 Participants |
| Previous Medication SGLT2 Inhibitor - No | 71 Participants | 406 Participants | 70 Participants | 65 Participants | 67 Participants | 66 Participants | 67 Participants |
| Previous Medication Sodium Glucose Co-transporter (SGLT2)Inhibitor-Yes | 3 Participants | 9 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Japan | 74 participants | 415 participants | 70 participants | 67 participants | 69 participants | 67 participants | 68 participants |
| Restricted Medication Anti-Diabetic Drug - No | 8 Participants | 25 Participants | 4 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants |
| Restricted Medication Anti-Diabetic Drug - Yes | 66 Participants | 390 Participants | 66 Participants | 64 Participants | 65 Participants | 64 Participants | 65 Participants |
| Restricted Medication Anti-Hypertension Drug - No | 28 Participants | 173 Participants | 25 Participants | 33 Participants | 25 Participants | 27 Participants | 35 Participants |
| Restricted Medication Anti-Hypertension Drug - Yes | 46 Participants | 242 Participants | 45 Participants | 34 Participants | 44 Participants | 40 Participants | 33 Participants |
| Restricted Medication HMG-CoA Reductase Inhibitor - No | 39 Participants | 221 Participants | 43 Participants | 40 Participants | 25 Participants | 37 Participants | 37 Participants |
| Restricted Medication HMG-CoA Reductase Inhibitor - Yes | 35 Participants | 194 Participants | 27 Participants | 27 Participants | 44 Participants | 30 Participants | 31 Participants |
| Sex: Female, Male Female | 17 Participants | 89 Participants | 14 Participants | 11 Participants | 18 Participants | 16 Participants | 13 Participants |
| Sex: Female, Male Male | 57 Participants | 326 Participants | 56 Participants | 56 Participants | 51 Participants | 51 Participants | 55 Participants |
| Trough Sitting Diastolic Blood Pressure | 80.6 mmHg STANDARD_DEVIATION 8.99 | 80.6 mmHg STANDARD_DEVIATION 9 | 80.5 mmHg STANDARD_DEVIATION 8.89 | 80.6 mmHg STANDARD_DEVIATION 8.8 | 81.9 mmHg STANDARD_DEVIATION 8.9 | 80.6 mmHg STANDARD_DEVIATION 9.29 | 79.3 mmHg STANDARD_DEVIATION 9.26 |
| Trough Sitting Systolic Blood Pressure | 138.2 mmHg STANDARD_DEVIATION 7.09 | 139.7 mmHg STANDARD_DEVIATION 7.63 | 140.6 mmHg STANDARD_DEVIATION 7.65 | 139.0 mmHg STANDARD_DEVIATION 8.41 | 140.3 mmHg STANDARD_DEVIATION 7.77 | 141.1 mmHg STANDARD_DEVIATION 7.01 | 139.0 mmHg STANDARD_DEVIATION 7.64 |
| Urine albumin/Creatinine ratio | 96.03 mg/gCR | 100.26 mg/gCR | 96.33 mg/gCR | 93.45 mg/gCR | 86.87 mg/gCR | 119.95 mg/gCR | 116.43 mg/gCR |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 67 | 7 / 67 | 8 / 74 | 9 / 68 | 11 / 69 | 11 / 70 |
| serious Total, serious adverse events | 2 / 67 | 0 / 67 | 0 / 74 | 0 / 68 | 2 / 69 | 1 / 70 |
Outcome results
Primary
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.
Time frame: Week 0 and Week 12
Population: Full analysis set (FAS) included all participants who were randomized and received at least one dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | 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) | 0.152 log (mg/gCr) |
| TAK-272 5 mg | 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) | -0.173 log (mg/gCr) |
| TAK-272 20 mg | 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) | -0.317 log (mg/gCr) |
| TAK-272 40 mg | 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) | -0.478 log (mg/gCr) |
| TAK-272 80 mg | 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) | -0.497 log (mg/gCr) |
| Candesartan Cilexetil 8 mg | 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) | -0.377 log (mg/gCr) |
p-value: <0.000195% CI: [-0.4845, -0.1649]ANCOVA
p-value: <0.000195% CI: [-0.6251, -0.3132]ANCOVA
p-value: <0.000195% CI: [-0.7897, -0.4711]ANCOVA
p-value: <0.000195% CI: [-0.8083, -0.4908]ANCOVA
p-value: <0.000195% CI: [-0.6874, -0.3719]ANCOVA
Secondary
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.
Time frame: Week 12
Population: The FAS included all participants who were randomized and received at least one dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Progression Rate From Early-Stage Nephropathy (Stage 2) to Overt Nephropathy (Stage 3) During the Treatment Period (Week 12) | 18.2 percentage of participants |
| TAK-272 5 mg | Progression Rate From Early-Stage Nephropathy (Stage 2) to Overt Nephropathy (Stage 3) During the Treatment Period (Week 12) | 3.0 percentage of participants |
| TAK-272 20 mg | Progression Rate From Early-Stage Nephropathy (Stage 2) to Overt Nephropathy (Stage 3) During the Treatment Period (Week 12) | 0.0 percentage of participants |
| TAK-272 40 mg | Progression Rate From Early-Stage Nephropathy (Stage 2) to Overt Nephropathy (Stage 3) During the Treatment Period (Week 12) | 0.0 percentage of participants |
| TAK-272 80 mg | Progression Rate From Early-Stage Nephropathy (Stage 2) to Overt Nephropathy (Stage 3) During the Treatment Period (Week 12) | 0.0 percentage of participants |
| Candesartan Cilexetil 8 mg | Progression Rate From Early-Stage Nephropathy (Stage 2) to Overt Nephropathy (Stage 3) During the Treatment Period (Week 12) | 1.4 percentage of participants |
Secondary
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).
Time frame: Week 12
Population: The FAS included all participants who were randomized and received at least one dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Remission Rate From Early-Stage Nephropathy (Stage 2) to Pre-Nephropathy Stage (Stage 1) at the End of Treatment (Week 12) | 0.0 percentage of participants |
| TAK-272 5 mg | Remission Rate From Early-Stage Nephropathy (Stage 2) to Pre-Nephropathy Stage (Stage 1) at the End of Treatment (Week 12) | 9.0 percentage of participants |
| TAK-272 20 mg | Remission Rate From Early-Stage Nephropathy (Stage 2) to Pre-Nephropathy Stage (Stage 1) at the End of Treatment (Week 12) | 9.5 percentage of participants |
| TAK-272 40 mg | Remission Rate From Early-Stage Nephropathy (Stage 2) to Pre-Nephropathy Stage (Stage 1) at the End of Treatment (Week 12) | 17.9 percentage of participants |
| TAK-272 80 mg | Remission Rate From Early-Stage Nephropathy (Stage 2) to Pre-Nephropathy Stage (Stage 1) at the End of Treatment (Week 12) | 24.6 percentage of participants |
| Candesartan Cilexetil 8 mg | Remission Rate From Early-Stage Nephropathy (Stage 2) to Pre-Nephropathy Stage (Stage 1) at the End of Treatment (Week 12) | 14.3 percentage of participants |
Secondary
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.
Time frame: Weeks 2, 4, 8, 12, follow-up (Week 14) and End of Treatment
Population: The FAS included all participants who were randomized and received at least one dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at particular timepoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Follow-up (Week 14) | 1.11 mg/gCr |
| Placebo | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 4 | 1.03 mg/gCr |
| Placebo | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 8 | 1.07 mg/gCr |
| Placebo | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | End of treatment | 1.15 mg/gCr |
| Placebo | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 12 | 1.13 mg/gCr |
| Placebo | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 2 | 1.04 mg/gCr |
| TAK-272 5 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Follow-up (Week 14) | 0.92 mg/gCr |
| TAK-272 5 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | End of treatment | 0.85 mg/gCr |
| TAK-272 5 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 4 | 0.82 mg/gCr |
| TAK-272 5 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 8 | 0.85 mg/gCr |
| TAK-272 5 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 12 | 0.85 mg/gCr |
| TAK-272 5 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 2 | 0.84 mg/gCr |
| TAK-272 20 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 2 | 0.80 mg/gCr |
| TAK-272 20 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | End of treatment | 0.72 mg/gCr |
| TAK-272 20 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 12 | 0.71 mg/gCr |
| TAK-272 20 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 4 | 0.80 mg/gCr |
| TAK-272 20 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 8 | 0.75 mg/gCr |
| TAK-272 20 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Follow-up (Week 14) | 0.95 mg/gCr |
| TAK-272 40 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 12 | 0.61 mg/gCr |
| TAK-272 40 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | End of treatment | 0.62 mg/gCr |
| TAK-272 40 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 2 | 0.73 mg/gCr |
| TAK-272 40 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Follow-up (Week 14) | 0.80 mg/gCr |
| TAK-272 40 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 4 | 0.66 mg/gCr |
| TAK-272 40 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 8 | 0.63 mg/gCr |
| TAK-272 80 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 8 | 0.62 mg/gCr |
| TAK-272 80 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 2 | 0.72 mg/gCr |
| TAK-272 80 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 4 | 0.71 mg/gCr |
| TAK-272 80 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 12 | 0.59 mg/gCr |
| TAK-272 80 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Follow-up (Week 14) | 0.86 mg/gCr |
| TAK-272 80 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | End of treatment | 0.61 mg/gCr |
| Candesartan Cilexetil 8 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 8 | 0.71 mg/gCr |
| Candesartan Cilexetil 8 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 4 | 0.72 mg/gCr |
| Candesartan Cilexetil 8 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 2 | 0.76 mg/gCr |
| Candesartan Cilexetil 8 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Week 12 | 0.70 mg/gCr |
| Candesartan Cilexetil 8 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | End of treatment | 0.69 mg/gCr |
| Candesartan Cilexetil 8 mg | Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point | Follow-up (Week 14) | 0.85 mg/gCr |
Other Pre-specified
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Time frame: Up to Week 14
Population: Safety analysis set included all participants who received at least one dose of the study drug for the treatment period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 28 Participants |
| TAK-272 5 mg | Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 22 Participants |
| TAK-272 20 mg | Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 26 Participants |
| TAK-272 40 mg | Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 28 Participants |
| TAK-272 80 mg | Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 36 Participants |
| Candesartan Cilexetil 8 mg | Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 30 Participants |