NL-OMON46385CompletedPhase 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 enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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.
- •7. Contraindications to dapagliflozin according to the local label.
- •8. Use of antidiabetic drugs other than metformin within 3 months prior to screening.
- •9. Weight gain or loss > 5 kg in the last 3 months, ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.
- •10. History of drug abuse or alcohol abuse in the past 12 months. Alcohol abuse is defined as > 14 drinks per week for women and > 21 drinks per week for men (1 drink = 35 cl beer, 14 cl wine or 4 cl hard liquor) or as judged by the Investigator.
- •11. Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis or other condition the Investigator believes would interfere with the patient*s ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the patient at undue risk.
- •12. Plasma donation within one month of screening or any blood donation/ blood loss > 500 mL within 3 months prior to screening or during the study.
- •13. Anemia defined as Hemoglobin (Hb) < 115 g/L (7.1 mM) in women and < 120 g/L (7.5 mM) in men.
- •14. Use of anti-coagulant treatment such as heparin, warfarin, platelet inhibitors, thrombin and factor X inhibitors.
- •15. Use of medication such as oral glucocorticoids, anti-estrogens or other medications that are known to markedly influence insulin sensitivity.
- •16. Use of loop diuretics.
- •17. Regular smoking and other regular nicotine use.
- •18. Any contra-indication to magnetic resonance imaging scanning. These contra indications include patients with following devices:
- •- Central nervous system aneurysm clip
- •- Implanted neural stimulator
- •- Implanted cardiac pacemaker of defibrillator
- •- Cochlear implant
- •- Metal containing corpora aliena in the eye or brain.
- •19. Patients, who do not want to be informed about unexpected medical findings, or do not wish that their physician be informed about coincidental findings, cannot participate in the study.
Investigators
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