Adults 20 to 74, any sex, with Type 2 Diabetes Mellitus and Microalbuminuria. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)Primary· 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.
Group
Value
95% CI
Placebo
0.152
0.0389 – 0.2655
TAK-272 5 mg
-0.173
-0.2848 – -0.0602
TAK-272 20 mg
-0.317
-0.4245 – -0.2095
TAK-272 40 mg
-0.478
-0.5904 – -0.3661
TAK-272 80 mg
-0.497
-0.6081 – -0.3867
Candesartan Cilexetil 8 mg
-0.377
-0.4872 – -0.2678
Urine Albumin/Creatinine Ratio (UACR) at Each Assessment PointSecondary· 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.
Week 2
Group
Value
95% CI
Placebo
1.04
0.979 – 1.112
TAK-272 5 mg
0.84
0.767 – 0.929
TAK-272 20 mg
0.80
0.736 – 0.873
TAK-272 40 mg
0.73
0.678 – 0.795
TAK-272 80 mg
0.72
0.659 – 0.797
Candesartan Cilexetil 8 mg
0.76
0.708 – 0.812
Week 4
Group
Value
95% CI
Placebo
1.03
0.930 – 1.132
TAK-272 5 mg
0.82
0.742 – 0.901
TAK-272 20 mg
0.80
0.731 – 0.881
TAK-272 40 mg
0.66
0.605 – 0.722
TAK-272 80 mg
0.71
0.638 – 0.781
Candesartan Cilexetil 8 mg
0.72
0.668 – 0.782
Week 8
Group
Value
95% CI
Placebo
1.07
0.974 – 1.182
TAK-272 5 mg
0.85
0.772 – 0.942
TAK-272 20 mg
0.75
0.686 – 0.817
TAK-272 40 mg
0.63
0.569 – 0.688
TAK-272 80 mg
0.62
0.552 – 0.690
Candesartan Cilexetil 8 mg
0.71
0.639 – 0.786
Week 12
Group
Value
95% CI
Placebo
1.13
1.025 – 1.238
TAK-272 5 mg
0.85
0.760 – 0.947
TAK-272 20 mg
0.71
0.631 – 0.793
TAK-272 40 mg
0.61
0.546 – 0.685
TAK-272 80 mg
0.59
0.519 – 0.672
Candesartan Cilexetil 8 mg
0.70
0.630 – 0.776
Follow-up (Week 14)
Group
Value
95% CI
Placebo
1.11
0.985 – 1.255
TAK-272 5 mg
0.92
0.830 – 1.031
TAK-272 20 mg
0.95
0.861 – 1.055
TAK-272 40 mg
0.80
0.725 – 0.872
TAK-272 80 mg
0.86
0.770 – 0.966
Candesartan Cilexetil 8 mg
0.85
0.771 – 0.936
End of treatment
Group
Value
95% CI
Placebo
1.15
1.048 – 1.267
TAK-272 5 mg
0.85
0.760 – 0.947
TAK-272 20 mg
0.72
0.644 – 0.815
TAK-272 40 mg
0.62
0.552 – 0.693
TAK-272 80 mg
0.61
0.540 – 0.698
Candesartan Cilexetil 8 mg
0.69
0.616 – 0.765
Remission Rate From Early-Stage Nephropathy (Stage 2) to Pre-Nephropathy Stage (Stage 1) at the End of Treatment (Week 12)Secondary· 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).
Group
Value
95% CI
Placebo
0.0
0.000 – 5.436
TAK-272 5 mg
9.0
3.358 – 18.480
TAK-272 20 mg
9.5
3.888 – 18.524
TAK-272 40 mg
17.9
9.612 – 29.196
TAK-272 80 mg
24.6
15.055 – 36.490
Candesartan Cilexetil 8 mg
14.3
7.069 – 24.707
Progression Rate From Early-Stage Nephropathy (Stage 2) to Overt Nephropathy (Stage 3) During the Treatment Period (Week 12)Secondary· 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.
Group
Value
95% CI
Placebo
18.2
9.764 – 29.607
TAK-272 5 mg
3.0
0.364 – 10.371
TAK-272 20 mg
0.0
0.000 – 4.863
TAK-272 40 mg
0.0
0.000 – 5.357
TAK-272 80 mg
0.0
0.000 – 5.206
Candesartan Cilexetil 8 mg
1.4
0.036 – 7.704
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)Secondary· 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.
Group
Value
95% CI
Placebo
28
TAK-272 5 mg
22
TAK-272 20 mg
26
TAK-272 40 mg
28
TAK-272 80 mg
36
Candesartan Cilexetil 8 mg
30
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Week 14.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 2/67 (3%)
Deaths: —
TAK-272 5 mg
Serious: 0/67 (0%)
Deaths: —
TAK-272 20 mg
Serious: 0/74 (0%)
Deaths: —
TAK-272 40 mg
Serious: 0/68 (0%)
Deaths: —
TAK-272 80 mg
Serious: 2/69 (3%)
Deaths: —
Candesartan Cilexetil 8 mg
Serious: 1/70 (1%)
Deaths: —
Serious adverse events (5 terms)
Reaction
System
Placebo
TAK-272 5 mg
TAK-272 20 mg
TAK-272 40 mg
TAK-272 80 mg
Candesartan Cilexetil 8 mg
Diverticulum intestinal haemorrhagic
Gastrointestinal disorders
—
—
—
—
—
—
Adenocarcinoma gastric
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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· NA
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NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 13 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02332824.