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

NCT ID: NCT01512849

Last Updated: 2026-01-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TA-7284 Low

Group Type EXPERIMENTAL

TA-7284 Low

Intervention Type DRUG

Low

TA-7284 High

Group Type EXPERIMENTAL

TA-7284 High

Intervention Type DRUG

High

Interventions

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TA-7284 Low

Low

Intervention Type DRUG

TA-7284 High

High

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nobuya Inagaki, MD

Role: STUDY_DIRECTOR

Kyoto University, Graduate School of Medicine

Kazuoki Kondo, MD

Role: STUDY_DIRECTOR

Tanabe Pharma Corporation

Locations

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Reserch site

Kanto, , Japan

Site Status

Countries

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Japan

References

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Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

Reference Type DERIVED
PMID: 38770818 (View on PubMed)

Other Identifiers

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TA-7284-07

Identifier Type: -

Identifier Source: org_study_id

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