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Clinical Trials/EUCTR2009-010221-39-NL
EUCTR2009-010221-39-NL
Active, not recruiting
Not Applicable

An Exploratory Phase 2 Study to Assess the Effect of Dapagliflozin on GlomerularFiltration Rate (GFR) in Subjects with Type 2 Diabetes who have Inadequate Glycemicand Blood Pressure (BP) ControlPharmacogenetics Blood Sample Amendment 01 (v1.0, dated 24-Jul-2009)

Bristol Myers Squibb International Corporation0 sites150 target enrollmentAugust 31, 2009
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DrugsHydrochlorothiazide 25 PCH, 25 mg tablets

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Bristol Myers Squibb International Corporation
Enrollment
150
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 31, 2009
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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 HbA1c \= 6\.6% and \= 9\.5% obtained at the enrollment visit.
  • •3\) Subjects should have been receiving metformin (XR or IR) and/or SU for at least 4
  • •weeks prior to enrollment at any stable dose. Stable dose is defined as a dose that has remained the same for at least 4 weeks prior to the enrollment visit (i.e., same
  • •prescribed total daily dose).
  • •4\) Subjects must have inadequate BP control, defined as seated SBP \= 130 and \< 165 mmHg AND/OR seated DBP \= 80 and \< 105 mmHg, each representing the mean of 3 consecutive determinations, evaluated at both the enrollment and Day \-7
  • •5\) C\-peptide \= 0\.8 ng/ml (0\.27 nmol/L) at the enrollment visit, based on central
  • •laboratory value.
  • •6\) BMI \= 45\.0 kg/m2 at the enrollment visit.

Exclusion Criteria

  • •1\) WOCBP who are unwilling or unable to use an acceptable method to avoid
  • •pregnancy for the entire study period.
  • •2\) Women who are pregnant or breastfeeding.
  • •3\) Women with a positive pregnancy test on enrollment or prior to investigational
  • •product administration and/or injection of iohexol, and, for subjects participating in
  • •the substudy, prior to administration of radioisotopes for determination of RCM and
  • •4\) Estimated GFR (eGFR) by the Modification of Diet in Renal Disease (MDRD) formula \= 60 mL/min/1\.73m2 and \= 150 mL/min/1\.73m2\.
  • •5\) Urine albumin to creatinine ratio (UACR) \= 300 mg/g (33\.9 mg/mmol/Cr).
  • •6\) Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN).
  • •7\) Alanine aminotransferase (ALT) \> 3X ULN.

Outcomes

Primary Outcomes

Not specified

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