Postmarketing Clinical Study on AO-128

Takeda197 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

197

Conditions

Impaired Glucose Tolerance (IGT)

Interventions

AO-128DRUG

AO-128 tablet

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Assessment of Diabetic Status in the Treatment Period (Type 2 Diabetes Mellitus, Normoglycemia, or Impaired Glucose Tolerance (IGT)

Frequency tabulations of the "assessment of diabetic status in the treatment period (Type 2 Diabetes mellitus, normoglycemia, or IGT)" were prepared in the "Full Analysis Set".

Time frame: Treatment period: Up to 122 weeks. Treatment was to be ended when patients were assessed as Type 2 Diabetes Mellitus or normoglycemic.

Assessment of Diabetic Status in Follow-up (Type 2 Diabetes Mellitus, Normoglycemia, or IGT)

Frequency tabulations of the "assessment of diabetic status in the follow-up (Type 2 Diabetes mellitus, normoglycemia, or IGT)" were prepared in patients who proceeded to the follow-up in the "Full Analysis Set".

Time frame: Follow-up at Week 12, 24, 36, and 48

Secondary Outcomes

Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated by the Kaplan-Meier Method

The cumulative progression rate (percentage of participants) was calculated by the Kaplan-Meier method for the "time to progression to Type 2 Diabetes mellitus in the treatment period" in the "Full Analysis Set".

Time frame: Day 168, 336, 504, and 672

Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated Using the Cumulative Incidence Function

The cumulative progression rate (percentage of participants) was calculated using the cumulative incidence function for the "time to progression to type 2 diabetes mellitus in the treatment period" in the "Full Analysis Set".

Time frame: Day 168, 336, 504, and 672

Time to Improvement to Normoglycemia in the Treatment Period Calculated by the Kaplan-Meier Method

The cumulative progression rate (percentage of participants) was calculated by the Kaplan-Meier method for the "time to improvement to normoglycemia in the treatment period" in the "Full Analysis Set".

Data from ClinicalTrials.gov

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