NCT00554450

Brief Summary

The purpose of the study is to assess the effect of dapagliflozin on renal glucose clearance in type 2 diabetic subjects with mild, moderate, and severe renal impairment compared to type 2 diabetic and healthy subjects with normal renal function

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

2.6 years

First QC Date

November 5, 2007

Last Update Submit

October 14, 2016

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

  • Urine will be collected over a 24 h period for determination of renal glucose clearance, total protein, and measurement of total glucose excreted in urine

    on Days -1, 1, 4 and 10

  • Blood samples for serum glucose and creatinine will be collected

    on Days -1, 1, 4 and 10 at selected timepoints

  • Blood and urine PK samples

    on Days 1, 4, 10

  • Iohexol PK blood & urine samples for GFR assessment

    on Day -12 to -5

Secondary Outcomes (5)

  • AEs, vital signs

    scr, Days -1, 1, 4-11, discharge

  • physical exams

    scr, Days -12 to -5, -1, discharge

  • ECGs

    scr, Days,-1, 4, 7, discharge

  • clinical labs

    scr, Day -1, 1, 4, 6, 8, 10, discharge

  • The following urine/serum safety parameters will be assessed: sodium, potassium, magnesium, phosphorus, calcium, and total protein (urine only)

    on Days -1, 1, 4 and 10

Study Arms (2)

Arm 1

EXPERIMENTAL

50 mg single dose

Drug: Dapagliflozin

Arm 2

EXPERIMENTAL

20 mg up to 7 days

Drug: Dapagliflozin

Interventions

DapagliflozinDRUG

Tablets, Oral, once daily

Arm 1Arm 2

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects in the following groups:
  • Group A: Healthy Subjects with Normal Renal Function (CLcr \> 80 mL/min) Group B: Diabetic Subjects with Normal Renal Function (CLcr \> 80 mL/min) Group C: Diabetic Subjects with Mild Renal Impairment (CLcr \> 50 - ≤80 mL/min) Group D: Diabetic Subjects with Moderate Renal Impairment (CLcr ≥ 30 - ≤50 mL/min) Group E: Diabetic Subjects with Severe Renal Impairment (CLcr \< 30 mL/min) (and not receiving dialysis)
  • Men and WOCBP, ages 18 to 79 years old

You may not qualify if:

  • History of diabetic ketoacidosis
  • HbA\*1c \> 10%
  • Serum albumin \< 2.0 gm/dL
  • Potassium \< 3.0 or \> 6.0 mEq/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Elite Research Institute

Miami, Florida, 33169, United States

Location

Prism Research

Saint Paul, Minnesota, 55114, United States

Location

Dgd Research, Inc.

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Kasichayanula S, Liu X, Pe Benito M, Yao M, Pfister M, LaCreta FP, Humphreys WG, Boulton DW. The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus. Br J Clin Pharmacol. 2013 Sep;76(3):432-44. doi: 10.1111/bcp.12056.

    PMID: 23210765RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 7, 2007

Study Start

March 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

US(4)