Postmarketing Clinical Study on AO-128

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Voglibose

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.