NL-OMON46385
Completed
Phase 4
DAPAMAAST: A Double-blind, Randomized, Phase IV, Mechanistic, Placebo-controlled, Cross-over, Single-center Study to Evaluate the Effects of 5 Weeks Dapagliflozin Treatment on Insulin Sensitivity in Skeletal Muscle in Type 2 Diabetes Mellitus Patients - DAPAMAAST
Astra Zeneca0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Astra Zeneca
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients are able to provide signed and dated written informed consent prior to any study specific procedures.
- •2\. Women are post\-menopausal (defined as at least 1 year post cessation of menses) and aged \>\= 45 and \<\= 70 years. Males are aged \>\= 40 years and \<\= 70 years. Patients should have suitable veins for cannulation or repeated venipuncture.
- •3\. Patients are diagnosed with T2DM for at least the last 6 months, based on American Diabetes Association 2016 standards
- •4\. Patients are on no anti\-diabetic drug treatment or on stable metformin treatment for at least the last 3 months: maximum 3000 mg metformin daily dose.
- •5\. HbA1c levels \>\=6\.0% (\=42 mmol/mol) and \<\=9\.0% (75 mmol/mol).
- •6\. Have a body mass index (BMI) \<\= 38 kg/m2\.
Exclusion Criteria
- •1\. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at third party vendor or at the investigational sites).
- •2\. Previous enrolment in the present study or participation in another clinical study with an investigational product during the last 3 months or as judged by the Investigator.
- •3\. History of or presence of any clinically significant disease or disorder including a recent (\< 3 months) cardiovascular event which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study or influence the results or the patient\*s ability to participate in the study.
- •4\. Clinical diagnosis of Type 1 diabetes, maturity onset diabetes of the young, secondary diabetes or diabetes insipidus.
- •5\. Unstable/rapidly progressing renal disease or estimated Glomerular Filtration Rate \< 60 mL/min (Cockcroft\-Gault formula).
- •Creatinine clearance (mL/min) \= Weight (kg) X (140\-Age) X 1\.23
- •Serum creatinine (µmol/l)
- •Creatinine clearance (mL/min) \= Weight (kg) X (140\-Age) X 1\.04
- •Serum creatinine (µmol/l)
- •6\. Clinically significant out of range values of serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase (ALP) in the Investigator\*s opinion.
Outcomes
Primary Outcomes
Not specified
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