Phase 2 N=75 Randomized Double-blind Basic Science

Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes

Type 2 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT00976495 ↗

Enrolled (actual)

Serious AEs

4.0%

Results posted

Mar 2017

Primary outcome: Primary: Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF]) — -2.92; -10.76; -3.40 % Change of Baseline GFR

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Dapagliflozin (Drug); Placebo (Drug); Hydrochlorothiazide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Nov 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF])	-2.92; -10.76; -3.40	—
SECONDARY Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])	-0.88; -3.28; -6.55	—
SECONDARY Adjusted Mean Change From Baseline in Daytime (0900 to 2100 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])	-1.55; -5.93; -6.83	—
SECONDARY Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])	-0.61; -0.45; -7.76	—

Summary

The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as assessed by glomerular filtration rate.

Eligibility Criteria

Inclusion Criteria

Type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 6.6 and ≤ 9.5%
Stable dose of metformin AND/OR a sulfonylurea, for at least 4 weeks prior to the enrollment visit
Inadequate blood pressure (BP) control, defined as systolic BP (SBP) ≥ 130 and 60 mL/min/1.73m² and 3X Upper limit of normal (ULN)
Alanine aminotransferase (ALT) > 3X ULN
Serum Total Bilirubin > 1.5X ULN
Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women
Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncologic, endocrine, psychiatric, or rheumatic diseases

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00976495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.