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Clinical Trials/EUCTR2008-001921-33-DK
EUCTR2008-001921-33-DKActive, not recruitingPhase 1

A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2/3 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects with Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control. Revised Protocol 04, incorporating Protocol Amendment 02 (V1.0, 10-Apr-2008), Amendment 03 (V1.0, 21-Nov-2008), Amendment 04 (V1.0, 07-Jul-2009) and Amendment 05 (V1.0, 31-Aug-2009). And Pharmacogenetics Blood Sample Amendment 01 - Site specific (V2.0, 10-Mar-2008).

Bristol-Myers Squibb International Corporation0 sites504 target enrollmentStarted: July 11, 2008Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
504
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1) Subjects must be willing and able to give signed and dated written informed consent.
  • •2) Subjects must have type 2 diabetes with inadequate glycemic control, defined as
  • •central laboratory A1C = 7.0% and = 11.0%.
  • •Note: A one-time central laboratory re-test of the A1C is allowed in subjects with an
  • •initial central enrollment A1C of 6.9% as determined by the Investigator. In situations
  • •where the central laboratory A1C value meets criteria for re-test, such a re-test of the A1C value is allowed provided the subject is otherwise fully eligible, as determined by the Investigator.
  • •3) Subjects on a stable anti-diabetic regimen. A stable anti-diabetic regimen is defined as either diet and exercise therapy alone or in combination with a regimen of any approved anti-diabetic medication(s), including insulin, in which either the doses of oral anti-diabetic medications, exenatide, or pramlintide have not changed during the 6 weeks prior to enrollment; or the doses of long-acting insulin or intermediate-acting insulin have not varied by more than 20% during the 6 weeks prior to enrollment.
  • •4) Subjects with moderate renal impairment. The degree of renal impairment is defined by the estimated GFR, according to the re-expressed abbreviated (four-variable) MDRD Study equation (see Protocol Section 4.1). Moderate renal impairment is defined as an eGFR 30 mL/min/1.73m2 to 59 mL/min/1.73m2.
  • •5) BMI = 45.0 kg/m2 at the enrollment visit.
  • •6) Men and women, = 18 years of age at the time of the enrollment visit.
  • •Women of childbearing potential (WOCBP) must be using an adequate method of
  • •contraception to avoid pregnancy throughout the study in such a manner that the
  • •risk of pregnancy is minimized.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •1)WOCBP unwilling or unable to use acceptable method to avoid pregnancy for entire study period
  • •2)Pregnant or breastfeeding Women
  • •3)Women with positive pregnancy test on enrollment or prior to investigational
  • •product administration
  • •4)Aspartate Aminotransferase >3X ULN
  • •5)Alanine Aminotransferase >3X ULN
  • •6)Total Bilirubin >2 mg/dL (34.2 µmol/L)
  • •7)Serum Potassium >5.5 meq/L (5.5 mmol/L)
  • •8)Serum Phosphorus =6.5 mg/dL (2.10 mmol/L)
  • •Note: one-time retest may be allowed, as determined by the Investigator, after minimum of 2 weeks following initiation or adjustment of phosphate binder medication. Such cases should be discussed with Sponsor prior to re-testing the serum phosphorus
  • •9)Serum Calcium <8 mg/dL or >ULN (<2.00 mmol/L or >ULN)
  • •10)Positive for hepatitis B surface antigen
  • •11)Positive for anti-hepatitis C virus antibody
  • •12)Hemoglobin =9.0 g/dL (90 g/L) for men; hemoglobin =8.0 g/dL (80 g/L) for women
  • •13)Creatine Kinase >3X ULN
  • •14)Abnormal free T4 values. Abnormal TSH value at enrollment will be further evaluated by free T4. Subjects with abnormal free T4 values will be excluded
  • •Note: A one-time retest may be allowed, as determined by the Investigator, after a
  • •minimum of 6 weeks following the adjustment of thyroid hormone replacement therapy in patients who have had a prior diagnosis of a thyroid disorder and who are currently receiving thyroid replacement therapy. Such cases should be discussed with the Sponsor prior to re-testing. The subject must have all enrollment procedures & laboratory assessments performed as part of this re-test, & all of these must meet enrollment eligibility criteria
  • •15)History of diabetes insipidus
  • •16)Symptoms of poorly controlled diabetes that would preclude participation in this trial including but not limited to marked polyuria & polydipsia with >10% weight loss during the 3 months prior to enrollment, or other signs & symptoms
  • •17)History of diabetic ketoacidosis or hyperosmolar nonketotic coma
  • •18)Severe uncontrolled hypertension defined as systolic blood pressure
  • •=180 mmHg &/or diastolic blood pressure =110 mmHg
  • •19)Myocardial infarction
  • •20)Cardiac surgery or revascularization
  • •21)Unstable angina
  • •22)Unstable congestive heart failure
  • •23)CHF New York Heart Association Class III or IV
  • •24)Transient ischemic attack or significant cerebrovascular disease
  • •25)Unstable or previously undiagnosed arrhythmia
  • •26)History of rapidly progressing renal disease
  • •27)History of lupus nephritis
  • •28)History of renal or systemic vasculitis
  • •29)History of familial renal glucosuria
  • •30)History of renal artery stenosis, with renovascular hypertension or ischemic
  • •nephropathy
  • •31)History of renal transplant
  • •32)Hemodialysis, ultrafiltration therapy, or peritoneal dialysis within 6 months prior to enrollment
  • •33)Significant hepatic disease, including, but not limited to, chronic active hepatitis
  • •1/or severe hepatic insufficiency
  • •34)Documented history of hepatotoxicity with any medication
  • •35)Documented history of severe hepatobiliary disease
  • •36)History of hemoglobinopathy with the exception of sickle cell trait or
  • •thalassemia minor; or chronic or recurrent hemolysis
  • •37)Donation of blood or blood products to a blood bank, blood transfusion, or
  • •participation in a clinical study requiring withdrawal of >400 mL of blood during
  • •6 weeks prior to enrollment visit
  • •38)Malignancy within 5Y of enrollment visit (with exception of treated basal cell or treated squamous cell carcinoma)
  • •39)Known immunocompromised status, including but not limited to, individu

Investigators

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