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Effects of Dapagliflozin 10 mg on Insulin Resistance in Patients With Type 2 Diabetes Mellitus (DERISC)

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ClinicalTrials.gov Identifier: NCT02426541
Recruitment Status : Completed
First Posted : April 27, 2015
Results First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Collaborators:
Antaros Medical AB
Bioventure Hub
43183 Mölndal
Sweden
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is an 8-week, single centre, randomized, parallel-group, double-blind, placebo-controlled Phase IV study to evaluate the effect of dapagliflozin on tissue specific insulin sensitivity in patients with Type 2 diabetes mellitus

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Dapagliflozin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 23, 2015
Actual Primary Completion Date : April 28, 2016
Actual Study Completion Date : April 28, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Adjusted Change From Baseline in Skeletal Muscle Insulin-stimulated Gluocose Uptake [ Time Frame: From baseline to Week 8 ]
    Adjusted change from baseline in skeletal muscle insulin-stimulated gluocose uptake (umol/min/kg)


Secondary Outcome Measures :
  1. Adjusted Change in Adipose Tissue Insulin-stimulated Glucose Uptake [ Time Frame: Baseline to Week 8 ]
    Change in adipose tissue insulin-stimulated glucose uptake assessed by hyperglycemic-euglycemic clamp using F-FDG PET

  2. Adjusted Change in Liver Insulin-stimulated Glucose Uptake From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ]
    Adjusted change in liver insulin-stimulated glucose uptake assessed by hyperglycemic-euglycemic clamp using F-FDG PET



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main 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:

    1. Hysterectomized females
    2. 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:

    1. Creatinine clearance <60mL/min (estimated with Cockroft-Gault formula).
    2. 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.
    3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426541


Locations
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Finland
Research Site
Turku, Finland
Sponsors and Collaborators
AstraZeneca
Antaros Medical AB
Bioventure Hub
43183 Mölndal
Sweden
Investigators
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Principal Investigator: Pirjo Nuutila, MD, PhD, Professor Turku PET Centre, Turku, Finland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02426541    
Other Study ID Numbers: D1690C00025
2014-005377-36 ( EudraCT Number )
First Posted: April 27, 2015    Key Record Dates
Results First Posted: February 5, 2018
Last Update Posted: February 5, 2018
Last Verified: July 2017
Keywords provided by AstraZeneca:
Diabetes Mellitus
Dapagliflozin
Placebo
Insulin resistance
Insulin sensitivity
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs