Phase 3 N=252 Randomized Double-blind Treatment

Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT00663260 ↗

Enrolled (actual)

252

Serious AEs

11.1%

Results posted

Feb 2017

Primary outcome: Primary: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF] — -0.32; -0.41; -0.44 % of hemoglobin — p=0.561

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Dapagliflozin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]	-0.32; -0.41; -0.44	0.561
SECONDARY Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])	8.4; -5.2; -0.6	—
SECONDARY Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])	0.27; -1.54; -1.89	—

Summary

The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment

Eligibility Criteria

Inclusion Criteria

Males and females, ≥18 years old, with type 2 diabetes and with inadequate glycemic control
Clinical diagnosis of moderate renal impairment

Exclusion Criteria

AST and /or ALT > 3.0 times the upper limit of normal
Serum total bilirubin > 1.5 times ULN
Symptoms of severely uncontrolled diabetes
Currently unstable or serious cardiovascular, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

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Data sourced from ClinicalTrials.gov (NCT00663260). 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.