An Efficacy, Safety, and Tolerability Study for TA-7284 in Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Dose-Ranging Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Efficacy, Safety, and Tolerability of Orally-Administered SGLT2 Inhibitor TA-7284

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022112
• Other study ID #: TA-7284-04
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2009
• Last updated: May 27, 2014
• Start date: November 2009
• Est. completion date: September 2010

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 demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with type 2 diabetes.

Description:

Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of T2DM and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, resulting in high rates of morbidity and mortality in the diabetic population. This is a randomized, double-blind, placebo-controlled, parallel-group study to demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with T2DM, who are not optimally controlled on diet and exercise. The primary study hypothesis is that the study drug will be superior to placebo as assessed by the change in HbA1c from baseline. The patients will receive tablets of TA-7284, or placebo, once daily for 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Aged from 20 to 80 years inclusive on the day of informed consent;

• Patients who was diagnosed with type 2 diabetes mellitus at least 3 months before the start of the run-in period;

• Patients with HbA1c of =6.5% and =9.5% (according to the Japan Diabetic Society [JDS] criteria) on the start day of the run-in period;

Exclusion Criteria:

• Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (acromegaly, Cushing's syndrome, etc.);

• Past or current history of severe diabetic complications (proliferative diabetic retinopathy, stage III or later stage overt nephropathy, diabetic ketoacidosis, or serious diabetic neuropathy);

• Fasting blood glucose of >270 mg/dL on the start day of the run-in period or at Week 2 of the run-in period;

• eGFR of <60 mL/min/1.73 m2 on the start day of the run-in period;

• Systolic blood pressure of =160 mmHg or diastolic blood pressure of =100 mmHg on the start or end day of the run-in period;

• History of myocardial infarction, unstable angina, or cerebrovascular disorder within 3 months before the start of the run-in period;

• Concurrent serious (e.g., requiring inpatient hospitalization or surgical intervention) renal or hepatic disease;

• Past or current history of malignant tumor; however, this criterion shall not apply to those who have been free of relapse for at least 5 years even with a history of malignant tumor.

• Past or current history of drug hypersensitivity such as shock and anaphylactoid symptoms;

• Pregnant women, lactating mothers, or women of childbearing potential;

• Any condition that subjects are assessed to be ineligible by the investigator (sub investigator).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Japan	Research site	Chugoku
Japan	Research site	Kanto
Japan	Research site	Kinki
Japan	Research site	Kyushu
Japan	Research site	Shikoku
Japan	Research site	Tohoku

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	Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)		12 weeks	No
Secondary	Fasting Blood Glucose, Body Weight		12 weeks	No
Secondary	Safety and Tolerability		14 weeks	Yes