Phase 4
Completed N=71
Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02227849 ↗Enrolled (actual)
71
Serious AEs
7.0%
Results posted
Mar 2019
Primary outcomePrimary: Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) — 5; 51 Participants
◆ Published Evidence
Established
28citations · ~4 / year
Efficacy and safety of canagliflozin as add-on therapy to a glucagon-like peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52-week, open-label, phase IV study.
Summary
The purpose of this study is to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with GLP-1 analogue in patients with type 2 Diabetes for 52 weeks.
Linked Publications
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Efficacy and safety of canagliflozin as add-on therapy to a glucagon-like peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52-week, open-label, phase IV study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events) |
5; 51 | — |
| SECONDARY Change in Percentage of HbA1c |
-0.70 | — |
| SECONDARY Change in Fasting Plasma Glucose |
-34.7 | — |
| SECONDARY Percentage Change in Body Weight |
-4.46 | — |
| SECONDARY Change in Blood Pressure |
-7.90; -4.32 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who has been receiving a stable dose and regimen of GLP-1 analogue over 12 weeks before administration of investigational dug
- Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
- Patients with HbA1c of ≥7.0% and <10.5%
- Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug
Exclusion Criteria
- Patients with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (Cushing's syndrome, acromegaly, etc.)
- Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)
- Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
- Patients with systolic blood pressure of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg
- Patients with serious renal or hepatic disease
- Patients with eGFR of <45 mL/min/1.73 m2
- Patients who are the excessive alcohol addicts
- Patients requiring insulin therapy
- Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception
Data sourced from ClinicalTrials.gov (NCT02227849) and the linked publication. 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.