Postmarketing Clinical Study on AO-128

NCT ID: NCT02287402

Last Updated: 2015-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-11-30

Brief Summary

The purpose of open-label study is to evaluate the efficacy and safety of AO-128 (Voglibose) 0.6 mg/day in patients with impaired glucose tolerance (IGT) who had been non-responsive to diet therapy and exercise therapy, and follow up the progress after the end of treatment in patients who was assessed as normoglycemic.

Detailed Description

The α-glucosidase inhibitor voglibose was developed by Takeda Pharmaceutical Co. Ltd and is one of the most commonly used oral antidiabetic agents in Japan. Voglibose is used as first-line treatment for improvement of postprandial hyperglycemia in diabetic patients with inadequate response to diet and exercise therapy and as add-on treatment to other oral antidiabetic drugs and insulin. In 2009, voglibose was approved in Japan for the management of prediabetes (IGT).

This study was a single-group, multi-center, open-label study. The study period consisted of a screening period of 1 week or less, a treatment period of 96 weeks or more, and a follow-up period of 48 weeks. However, if a patient was assessed as having type 2 diabetes mellitus or normoglycemia, the treatment period was to be ended, and only those assessed as normoglycemic were to proceed to follow-up. Follow-up was also to be terminated if patients were assessed as having IGT or type 2 diabetes mellitus during follow-up.

Conditions

Impaired Glucose Tolerance (IGT)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AO-128 0.6 mg

One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.

Group Type: EXPERIMENTAL

AO-128

Intervention Type: DRUG

AO-128 tablet

Interventions

AO-128

AO-128 tablet

Intervention Type: DRUG

Other Intervention Names

Voglibose; BASEN

Eligibility Criteria

Inclusion Criteria

1. Patients on diet therapy and exercise therapy for 3 to 6 months prior to the start of screening, with baseline (fasting ) plasma glucose < 126 mg/dL and 2-hour plasma glucose of 140 to 199 mg/dL (revised WHO criteria) during a 75 g oral glucose tolerance test (OGTT) in the screening period

2. Patients meeting any of 1 through 4 below:

• 1) Comorbid hypertension or high normal blood pressure
• 2) Comorbid dyslipidemia
• 3) Comorbid obesity
• 4) Patients with up to a second-degree family history of type 2 diabetes mellitus

3. Patients with HbA1c < 6.5% in the screening period

4. Male or female patients at least 20 years of age at the time informed consent was obtained

5. Treatment category: Outpatient

Exclusion Criteria

1. Patients previously diagnosed with diabetes mellitus.

2. Patients with apparent impaired glucose metabolism or with a disease or condition potentially involving impaired glucose metabolism.

3. Patients with serious hepatic impairment.

4. Patients with serious renal impairment.

5. Patients with serious cardiac, cerebrovascular, pancreatic, hematologic, or other disease.

6. Patients with a history of intestinal obstruction or a history of laparotomy within 6 months (24 weeks) before the start of screening.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Other Identifiers

JapicCTI-101004

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1163-1618

Identifier Type: REGISTRY

Identifier Source: secondary_id

AO-128/OCT-910

Identifier Type: -

Identifier Source: org_study_id