Phase 3
Completed N=272
Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01413204 ↗Enrolled (actual)
272
Serious AEs
1.5%
Results posted
Jun 2014
Primary outcomePrimary: Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value) — -0.74; -0.76; 0.29 percent HbA1C
Summary
The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value) |
-0.74; -0.76; 0.29 | — |
| SECONDARY Change in Fasting Plasma Glucose |
— | — |
| SECONDARY Change in Body Weight |
— | — |
| SECONDARY Change in Blood Pressure |
— | — |
| SECONDARY Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test |
— | — |
| SECONDARY Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs |
— | — |
Eligibility Criteria
Inclusion Criteria
- Men or women age ≥20 years old
- Diagnosed with Type 2 diabetes mellitus at least 3 months before run-in period
- HbA1c of ≥7.0% and ≤10.0%
Exclusion Criteria
- Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
- Past or current history of severe diabetic complications
- Fasting plasma glucose > 270 mg/dL before treatment start
- History of hereditary glucose-galactose malabsorption or primary renal glucosuria
- Patients requiring insulin therapy
Data sourced from ClinicalTrials.gov (NCT01413204). 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.