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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

Effects of dapagliflozin on kidney function (glomerular filtration rate) in subjects with type 2 diabetes

NCT ID

Therapeutic Area

Tablets, Oral, 10 mg, once daily, 12 weeks

Tablets, Oral, 0 mg, once daily, 12 weeks

Tablets, Oral, 25 mg, once daily, 12 weeks

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Orlando Clinical Research Center

Prism Research

Compass Research, Llc

Zablocki Veterans Affairs Medical Center

Elite Research Institute

Local Institution

Memorial Hospital Of Rhode Island

University Of Michigan

Torrance Clinical Research

Advanced Clinical Res Inst

An Exploratory Phase 2 Study to Assess the Effect of Dapagliflozin on Glomerular Filtration Rate (GFR) in Subjects with Type 2 Diabetes who have Inadequate Glycemic and Blood Pressure (BP) Control

Age Continuous

Age, Customized

Gender, Customized

Race/Ethnicity, Customized

All randomized participants who received at least 1 dose of study medication

Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. If no Week 12 measurement was available, the last available post-baseline measurement obtained on or after Day 23 was used regardless of rescue medication. Measurements were obtained during radomization visit, and Week 12 in the double-blind period by a central laboratory.

All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 12 (MLOCF)

Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF])

Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during lead-in, and Week 12 in the double-blind period.

All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF)

Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])

Adjusted Mean Change From Baseline in Daytime (0900 to 2100 hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])

Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF])

Arms	Assigned Interventions
Experimental: Dapagliflozin	Drug: Dapagliflozin Tablets, Oral, 10 mg, once daily, 12 weeks Other Name: BMS-512148 Drug: Placebo Tablets, Oral, 0 mg, once daily, 12 weeks
Active Comparator: Hydrochlorothiazide	Drug: Hydrochlorothiazide Tablets, Oral, 25 mg, once daily, 12 weeks

Effects of dapagliflozin on kidney function (glomerular filtration rate) in subjects with type 2 diabetes

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Publication

MB102035_Redacted_CSR_synopsis

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator