Effects of Dapagliflozin 10 mg on Insulin Resistance in Patients With Type 2 Diabetes Mellitus.
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Dapagliflozin (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Pirjo Nuutila, MD, PhD, Professor, Principal Investigator, Affiliation: Turku PET Centre, Turku, Finland
Overall contact:
AstraZeneca Clinical Study Information Center, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in skeletal muscle insulin stimulated glucose uptake (µmol/min/kg) from baseline to end of treatment.
Secondary outcome: Change in adipose tissue insulin stimulated glucose uptake (µmol/min/kg) from baseline to end of treatment.Change in liver insulin stimulated glucose uptake (µmol/min/kg) from baseline to end of treatment.
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
AstraZeneca Clinical Study Information Center, Phone: 1-877-240-9479, Email: information.center@astrazeneca.com
Research Site, Turku, Finland; Recruiting
Additional Information
Starting date: March 2015
Last updated: August 10, 2015
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