A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

Type 2 Diabetes Mellitus Clinical Trial

Official title:

An Open-Label, Randomized, 2 Way Crossover, Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512849
• Other study ID #: TA-7284-07
• Status: Completed
• Phase: Phase 1
• First received: January 13, 2012
• Last updated: May 13, 2014
• Start date: January 2012
• Est. completion date: September 2012

Study information

• Verified date: May 2014
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment.

Description:

This is an open-label, randomized, 2-way crossover study to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment relative to patients with type 2 diabetes mellitus who have normal renal function. The patients will receive both TA-7284-Low and TA-7284-High orally alone in either Period 1 or 2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 79 Years

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes mellitus in stable condition who have normal renal function or moderate renal impairment

• Body mass index of =18.5 kg/m2 and =39.9 kg/m2 at screening

• HbA1c of =6.5% and =10.5% at screening

Exclusion Criteria:

• Type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus

• Past or current history of severe diabetic complications

• Patients requiring insulin therapy

• History of hereditary glucose-galactose malabsorption or primary renal glucosuria

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• TA-7284 Low
Low
• TA-7284 High
High

Locations

Country	Name	City	State
Japan	Reserch site	Kanto

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Renal Function on Maximum Plasma Concentration of TA-7284		For 72 hours after each administration	No
Primary	Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284		For 72 hours after each administration	No
Primary	Effect of Renal Function on Urinary Glucose Excretion of TA-7284		For 24 hours after each administration	No
Primary	Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284	The percent inhibition of renal glucose reabsorption was calculated from renal glucose reabsorption (eGFR × plasma glucose AUC - urinary glucose excretion) on the preceding day and on the day of administration.	For 24 hours after each administration	No
Secondary	Adverse Events	Incidence and severity of AEs	Upto approximately 14 days after last administration	Yes
Secondary	12-lead Electrocardiogram (ECG)	Change from baseline in ECG parameters	For 72 hours after each administration	No
Secondary	Vital Signs	Change from baseline in Vital signs (BP, PR and BT)	For 72 hours after each administration	No
Secondary	Clinical Laboratory Tests	Change from baseline in Clinical laboratory tests	For 72 hours after each administration	No