Trial record 1 of 1 for:
TA-7284-07
A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
This study has been completed.
Sponsor:
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01512849
First received: January 13, 2012
Last updated: September 19, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: TA-7284 Low Drug: TA-7284 High |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Mitsubishi Tanabe Pharma Corporation:
Primary Outcome Measures:
- Effect of renal function on the pharmacokinetics/dynamics of TA-7284 [ Time Frame: For 72 hours after each administration ] [ Designated as safety issue: No ]To characterize the PK and PD profile in patients with type 2 diabetes mellitus who have moderate renal impairment, compared with patients with type 2 diabetes mellitus who have normal renal function.
Secondary Outcome Measures:
- Adverse events [ Time Frame: Upto approximately 14 days after last administration ] [ Designated as safety issue: Yes ]Incidence and severity of AEs
- 12-lead electrocardiogram (ECG) [ Time Frame: For 72 hours after each administration ] [ Designated as safety issue: No ]Change from baseline in ECG parameters
- Vital signs [ Time Frame: For 72 hours after each administration ] [ Designated as safety issue: No ]Change from baseline in Vital signs (BP, PR and BT)
- Clinical laboratory tests [ Time Frame: For 72 hours after each administration ] [ Designated as safety issue: No ]Change from baseline in Clinical laboratory tests
| Enrollment: | 24 |
| Study Start Date: | January 2012 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: TA-7284 Low |
Drug: TA-7284 Low
Low
|
| Experimental: TA-7284 High |
Drug: TA-7284 High
High
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 40 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512849
Locations
| Japan | |
| Reserch site | |
| Kanto, Japan | |
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
| Study Director: | Nobuya Inagaki, MD | Kyoto University, Graduate School of Medicine |
| Study Director: | Kazuoki Kondo, MD | Mitsubishi Tanabe Pharma Corporation |
More Information
No publications provided
| Responsible Party: | Mitsubishi Tanabe Pharma Corporation |
| ClinicalTrials.gov Identifier: | NCT01512849 History of Changes |
| Other Study ID Numbers: | TA-7284-07 |
| Study First Received: | January 13, 2012 |
| Last Updated: | September 19, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
|
TA-7284 JNJ-28431754 Canagliflozin Renal Impairment Sodium Glucose Co-transporter2 (SGLT2) inhibitor |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Renal Insufficiency Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013