Status:
COMPLETED
Postmarketing Clinical Study on AO-128
Lead Sponsor:
Takeda
Conditions:
Impaired Glucose Tolerance (IGT)
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 an...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
- Patients with HbA1c \< 6.5% in the screening period
- Male or female patients at least 20 years of age at the time informed consent was obtained
- Treatment category: Outpatient
Exclusion
- Patients previously diagnosed with diabetes mellitus.
- Patients with apparent impaired glucose metabolism or with a disease or condition potentially involving impaired glucose metabolism.
- Patients with serious hepatic impairment.
- Patients with serious renal impairment.
- Patients with serious cardiac, cerebrovascular, pancreatic, hematologic, or other disease.
- Patients with a history of intestinal obstruction or a history of laparotomy within 6 months (24 weeks) before the start of screening.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT02287402
Start Date
March 1 2010
End Date
November 1 2012
Last Update
April 9 2015
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