Renal Impairment in Type 2 Diabetic Subjects

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Pharmacodynamics, Pharmacokinetics, and Safety of Dapagliflozin in Type 2 Diabetic Subjects With Mild, Moderate, and Severe Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554450
• Other study ID #: MB102-007
• Status: Completed
• Phase: Phase 1
• First received: November 5, 2007
• Last updated: October 14, 2016
• Start date: March 2006
• Est. completion date: October 2008

Study information

• Verified date: October 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

Key Inclusion Criteria:

• 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

Standard Exclusion Criteria, plus:

• History of diabetic ketoacidosis

• HbA*1c > 10%

• Serum albumin < 2.0 gm/dL

• Potassium < 3.0 or > 6.0 mEq/L

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Insufficiency

Intervention

Drug:
• Dapagliflozin
Tablets, Oral, once daily

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Elite Research Institute	Miami	Florida
United States	Dgd Research, Inc.	San Antonio	Texas
United States	Prism Research	St. Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Blood samples for serum glucose and creatinine will be collected		on Days -1, 1, 4 and 10 at selected timepoints	No
Primary	Blood and urine PK samples		on Days 1, 4, 10	No
Primary	Iohexol PK blood & urine samples for GFR assessment		on Day -12 to -5	No
Secondary	AEs, vital signs		scr, Days -1, 1, 4-11, discharge	Yes
Secondary	physical exams		scr, Days -12 to -5, -1, discharge	No
Secondary	ECGs		scr, Days,-1, 4, 7, discharge	No
Secondary	clinical labs		scr, Day -1, 1, 4, 6, 8, 10, discharge	No
Secondary	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	Yes

External Links

•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   MB102007 _Redacted _CSR _synopsis