Phase 4
Completed N=269
Efficacy and Safety Study of Empagliflozin as add-on to Insulin in Japanese Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02589639 ↗Enrolled (actual)
269
Serious AEs
8.6%
Results posted
Mar 2019
Primary outcomePrimary: Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment. — 0.00; -0.92; -1.00 percentage of HbA1c — p=<0.0001
◆ Published Evidence
Established
43citations · ~11 / year
Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials.
Summary
This is a multi-center, randomised, double-blind, placebo-controlled, parallel-group, efficacy and safety study of empagliflozin as add-on to insulin in Japanese patients with Type 2 Diabetes Mellitus with insufficient glycaemic control
Linked Publications
-
Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment. |
0.00; -0.92; -1.00 | <0.0001 sig |
| SECONDARY Percentage of Patients With Investigator Defined Drug-Related Adverse Events (AEs) |
25.6; 43.0; 43.3 | — |
Eligibility Criteria
Inclusion criteria
- Diagnosis of type 2 diabetes mellitus
- Patients on diet and exercise regimen who are pre-treated with any insulin therapy alone or in combination with 1 oral antidiabetic drug for at least 12 weeks prior to screening
- Fasting C-peptide must be > 0.5 ng/mL
- HbA1c at screening in Patients who are treated with insulin alone must be >=7.5% and =7.0% and =7.5% and =20 and 22 and <=40 kg/m2
- Further inclusion criteria apply
Exclusion criteria
- Patients who experience uncontrolled hyperglycaemia before randomization
- Patients who are treated with sulfonylurea whose dose is more than a half of daily maximum approval dose, glucagon-like peptide-1 (GLP-1) analogue, thiazolidinedione and sodium-glucose co-transporter 2 (SGLT-2) inhibitor
- Patients with recent cardiovascular and/or stroke events
- Patients with hepatic and/or renal dysfunction
- Patients who received anti-obesity drugs or other treatment leading to unstable body weight
- Patients who have known allergy or hypersensitivity to insulin and/or empagliflozin
- Pre-menopausal women who are nursing or pregnant
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02589639) 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.