Effects of dapagliflozin 10 mg on insulin resistance in patients with type 2 diabetes mellitus - DERISC

Study identifier:D1690C00025

ClinicalTrials.gov identifier:NCT02426541

EudraCT identifier:2014-005377-36

CTIS identifier:N/A

Study Complete

Official Title

An 8-week, single centre, randomized, parallel-group, double-blind, placebo controlled phase IV study to evaluate Dapagliflozin 10 mg once daily effects on insulin resistance in subjects with type 2 diabetes mellitus

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 4

Healthy volunteers

Study drug

Dapagliflozin, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

35 Years - 70 Years

Date

Study Start Date: 23 Mar 2015

Primary Completion Date: 28 Apr 2016

Study Completion Date: 28 Apr 2016

Study design

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

Verification:

Verified 01 Jul 2017 by AstraZeneca

Collaborators

Antaros Medical AB, Bioventure Hub, 43183 Mölndal, Sweden

Inclusion and exclusion criteria

Inclusion Criteria

1) Provision of signed informed consent prior to any study specific procedures.
2) Female or male aged 35 to 70 years inclusive with suitable veins for cannulation or repeated venipuncture
3) Type 2 Diabetes mellitus defined as HbA1c of ≥ 6.5% and ≤ 10.5%.
4) Stable (≥ 3 months) T2D treatment with metformin and/or metformin+dipeptidyl peptidase-4 inhibitors (DPP-IV)
5) Body mass index (BMI) ≤ 40 kg/m2.
6) Female subjects must be of non-childbearing potential, meeting at least one of the following criteria:
a) Hysterectomized females
b) Postmenopausal women, defined as women who have not had a menstrual period within 1 year
Main

Exclusion Criteria

1) Any condition that is contraindicated with MRI such as, but not limited to, having a pacemaker or claustrophobia.
2) Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
3) Recent Cardiovascular Events in a patient:
- Acute Coronary Syndrome (ACS) within 2 months prior to enrolment
- Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment
- Acute Stroke or Transient Ischemic Attack (TIA) within two months prior to enrolment
- Less than two months post coronary artery revascularization
4) Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure.
5) Blood pressure at enrolment: Systolic BP ≥165 mm Hg and/or diastolic BP ≥100 mm Hg
6) Any clinically significant illness, medical or surgical procedure or trauma within 4 weeks of the first administration of the investigational product.
7) On insulin, GLP-1 or other oral antidiabetic drug treatment (metformin or both metformin and DPP-IV allowed) or using other medications known to affect glucose metabolism.
8) Any clinically significant abnormalities in physical examination, Electrocardiography (ECG) or clinical chemistry results as judged by the investigator. The following specific exclusion criteria apply to the selected Clinical Chemistry results:
a) Creatinine clearance <60mL/min (estimated with Cockroft-Gault formula).
b) Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN.
c) Total bilirubin (TB) >2.0 mg/dL (34.2 µmol/L).
9) Body weight loss greater than 5% within 3 months prior to Visit 1.
10) Previous PET scan
11) History of or presence of (as found at Visit 1) any clinically significant disease, disorder or condition which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study.

No locations available

Arms	Assigned Interventions
Experimental: Dapagliflozin Dapagliflozin Once Daily 10 mg	Drug: Dapagliflozin Dapagliflozin 10 mg Tablets, Oral, Once Daily, 8 weeks Other Name: Forxiga, Farxiga
Placebo Comparator: Placebo Matching placebo for Dapagliflozin Once Daily 10 mg	Drug: Placebo Matching placebo to Dapagliflozin 10 mg Tablets, Oral, Once Daily, 8 weeks

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Pirjo Nuutila

Turku PET Centre, Turku, Finland