Phase 1
Completed N=24
A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Source: ClinicalTrials.gov NCT01512849 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Effect of Renal Function on Maximum Plasma Concentration of TA-7284 — 1197.1264; 2333.3617; 1213.6571; 2415.6109 ng / mL
Summary
The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Renal Function on Maximum Plasma Concentration of TA-7284 |
1197.1264; 2333.3617; 1213.6571; 2415.6109 | — |
| PRIMARY Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284 |
8766; 17835; 6929; 14815 | — |
| PRIMARY Effect of Renal Function on Urinary Glucose Excretion of TA-7284 |
61.017; 70.904; 86.592; 103.052 | — |
| PRIMARY Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284 |
60.8; 66.5; 47.8; 52.7 | — |
| SECONDARY Adverse Events |
— | — |
| SECONDARY 12-lead Electrocardiogram (ECG) |
— | — |
| SECONDARY Vital Signs |
— | — |
| SECONDARY Clinical Laboratory Tests |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients with type 2 diabetes mellitus in stable condition who have normal renal function or moderate renal impairment
- Body mass index of ≥18.5 kg/m2 and ≤39.9 kg/m2 at screening
- HbA1c of ≥6.5% and ≤10.5% at screening
Exclusion Criteria
- Type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
- Past or current history of severe diabetic complications
- Patients requiring insulin therapy
- History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Data sourced from ClinicalTrials.gov (NCT01512849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.