The safety and efficacy of dapagliflozin therapy in combination with insulin in Japanese subjects with T1DM

Study identifier:D1695C00001

ClinicalTrials.gov identifier:NCT02582814

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A clinical pharmacology and long term study to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of dapagliflozin therapy in combination with insulin in Japanese subjects with type 1 diabetes who have inadequate glycemic control

Medical condition

Type 1 Diabetes Mellitus

Phase

Phase 3

Healthy volunteers

Study drug

Dapagliflozin 5 mg, Dapagliflozin 10mg

Sex

All

Actual Enrollment

151

Study type

Interventional

Age

18 Years - 75 Years

Date

Study Start Date: 26 Oct 2015

Primary Completion Date: 15 Jun 2017

Study Completion Date: 15 Jun 2017

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2019 by AstraZeneca

Collaborators

Inclusion and exclusion 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 < 0.7 ng/mL
-Insulin use for at least 12 months prior to the enrolment per subject report or medical records and Method of insulin administration (MDI or CSII) must have been unchanged for at least 3 months prior to the enrolment per subject report or medical records. Subjects must be taking a total daily insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior to the enrolment. If on MDI insulin administration subject must be on ≥ 3x injections per day.
- Japanese men and women
- Screening Visit: Central laboratory HbA1c ≥ 7.5% and ≤ 10.5%
- BMI ≥ 20.0 kg/m² at visit 1
- Age 18 to 75 years, inclusive

Exclusion Criteria

- Target Disease Exceptions
History of T2DM
Maturity onset diabetes of young (MODY)
Any anti-hyperglycemic agent use, other than α-GI or insulin, within 1 month prior to the enrolment.
Use of thiazolidinediones within 6 months prior to the enrolment
History of DKA requiring medical intervention within 1 month prior to the enrolment
History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to the enrolment
- Medical History and Concurrent Diseases
Malignancy within 5 years of the enrolment (with the exception of treated basal cell or treated squamous cell carcinoma)
History of bladder cancer
History of radiation therapy to the lower abdomen or pelvis at any time
- Physical and Laboratory Test Findings
Aspartate aminotransferase (AST) > 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

No locations available

Arms	Assigned Interventions
Experimental: dapagliflozin 5mg + insulin dapagliflozin tablet 5mg + adjustable insulin	Drug: Dapagliflozin 5 mg Dapagliflozin, a blood glucose lowering drug. Oral dose
Experimental: dapagliflozin 10mg + insulin dapagliflozin tablet 10mg + adjustable insulin	Drug: Dapagliflozin 10mg Dapagliflozin, a blood glucose lowering drug. Oral dose

Documents available

D1695C00001_SAP_redacted
Download
D1695C00001_CSP_redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]