Phase 4
Completed N=146
Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02220920 ↗Enrolled (actual)
146
Serious AEs
2.7%
Results posted
Dec 2016
Primary outcomePrimary: Change in HbA1c From Baseline — -0.97; 0.13 Percent — p=<0.001
◆ Published Evidence
Established
70citations · ~7 / year
Efficacy and safety of canagliflozin in combination with insulin: a double-blind, randomized, placebo-controlled study in Japanese patients with type 2 diabetes mellitus.
Summary
The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.
Linked Publications
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Efficacy and safety of canagliflozin in combination with insulin: a double-blind, randomized, placebo-controlled study in Japanese patients with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline |
-0.97; 0.13 | <0.001 sig |
| SECONDARY Change in Fasting Plasma Glucose |
-34.1; -1.4 | <0.001 sig |
| SECONDARY Percent Change in Body Weight |
-2.13; 0.24 | <0.001 sig |
| SECONDARY Change in Blood Pressure |
-3.58; -0.40; -1.55; -0.31 | 0.058 |
| SECONDARY Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased" |
68.0; 64.8; 40.0; 29.6 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who has been receiving a stable dose and regimen of insulin 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 ≥7.5% 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 who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception
Data sourced from ClinicalTrials.gov (NCT02220920) 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.