Phase 3
Completed N=151
The Safety and Efficacy of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM
Source: ClinicalTrials.gov NCT02582814 ↗Enrolled (actual)
151
Serious AEs
6.6%
Results posted
Apr 2019
Primary outcomePrimary: Overall Adverse Event Summary — 67; 55; 23; 22 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will enroll eligible subjects into a long-term safety study (Part B).
Japanese male and female patients with T1DM and age 18 to 75 years, with inadequate glycemic control on insulin defined as HbA1c ≥ 7.5% and ≤ 10.5% at screening visit. As a condition of enrollment, subjects must be on a total daily insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior to the screening visit. The study design of Part B is a randomized, open-label, 2 arm, parallel-group design. 140 Japanese subjects in total will be randomized in a 1:1 ratio into one of the two treatment arms; dapagliflozin 5 mg or dapagliflozin 10 mg.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Adverse Event Summary |
67; 55; 23; 22; 7; 3 | — |
| PRIMARY Hypoglycemia |
75; 75; 2; 5; 67; 73 | — |
| PRIMARY Diabetic Ketoacidosis (DKA) |
2; 1; 1; 0; 0; 0 | — |
| PRIMARY Vital Signs (Heart Rate) |
-0.3; 0.4 | — |
| PRIMARY ECGs |
65; 67; 11; 8; 0; 0 | — |
| PRIMARY Clinical Laboratory Measures, Urine Test Results (Any Marked Abnormality) |
1; 0; 2; 1; 0; 1 | — |
| PRIMARY Vital Signs (Blood Pressure) |
-3.4; -2.9; -0.6; -1.0 | — |
| SECONDARY Adjusted Change From Baseline in HbA1c |
-0.52; -0.66; -0.33; -0.36 | — |
| SECONDARY Adjusted Percent Change From Baseline in Total Daily Insulin Dose |
-15.30; -15.14; -12.27; -13.13 | — |
| SECONDARY Adjusted Percent Change From Baseline in Body Weight |
-3.88; -5.26; -4.25; -5.96 | — |
| SECONDARY Adjusted Change From Baseline in Glycoalbumin |
-2.26; -2.63; -1.49; -1.68 | — |
| SECONDARY Adjusted Change From Baseline in Average Daily Glucose Measured by 6-point SMBG |
-9.37; -15.06; -11.62; -12.93 | — |
| SECONDARY Adjusted Change From Baseline in Post-prandial Glucose Measured by 6-point SMBG |
-2.33; -10.08; -6.40; -5.24 | — |
| SECONDARY Proportion of Subjects Achieving HbA1c Reduction of 0.5 Percent Without Severe Hypoglycemia |
60.8; 61.3; 51.4; 41.3 | — |
| SECONDARY Proportion of Subjects Achieving HbA1c Reduction of 0.5 Percent |
62.2; 66.7; 51.4; 45.3 | — |
| SECONDARY Proportion of Subjects Achieving HbA1c < 7.0 Percent |
9.5; 5.3; 6.8; 2.7 | — |
| SECONDARY Adjusted Change From Baseline in SBP in Subjects With Baseline SBP/DBP >= 140/90 mmHg |
-5.8; -12.0; -9.8; -14.2 | — |
Eligibility Criteria
Inclusion Criteria
- Signed Written Informed Consent
- Diagnosis of T1DM. In addition, the following criteria also needs to be met; Central laboratory test of C-peptide 3x upper limit of normal (ULN) Alanine aminotransferase (ALT) > 3x ULN Serum total bilirubin (TB) > 2.0 mg/dL (34.2 μmol/L) Estimated GFR (eGFR) by the Japanese Society of Nephrology formula ≤ 45 mL/min/1.73m2 Hemoglobin ≤ 11.0 g/dL (110 g/L) for men; hemoglobin ≤ 10.0 g/dL (100 g/L) for women.
Positive for hepatitis B surface antigen or anti-hepatitis C virus antibody Abnormal Free T4
Data sourced from ClinicalTrials.gov (NCT02582814). 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.