Clinical trial NCT02287402: Postmarketing Clinical Study on AO-128
Official title: Postmarketing Clinical Study on AO-128
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impaired Glucose Tolerance (IGT)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-11-10
Enrollment: 197
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assessment of Diabetic Status in the Treatment Period (Type 2 Diabetes Mellitus, Normoglycemia, or Impaired Glucose Tolerance (IGT)
timeFrame: Treatment period: Up to 122 weeks. Treatment was to be ended when patients were assessed as Type 2 Diabetes Mellitus or normoglycemic.
measure: Assessment of Diabetic Status in Follow-up (Type 2 Diabetes Mellitus, Normoglycemia, or IGT)
timeFrame: Follow-up at Week 12, 24, 36, and 48
Secondary outcomes:
measure: Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated by the Kaplan-Meier Method
timeFrame: Day 168, 336, 504, and 672
measure: Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated Using the Cumulative Incidence Function
timeFrame: Day 168, 336, 504, and 672
measure: Time to Improvement to Normoglycemia in the Treatment Period Calculated by the Kaplan-Meier Method
timeFrame: Day 168, 336, 504, and 672
measure: Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function
timeFrame: Day 168, 336, 504, and 672
measure: 2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)
timeFrame: Week 0, 24, 48, 72, 96, 120, and the end of the treatment period
measure: 2-Hour Plasma Glucose During 75 g OGTT at Follow-up
timeFrame: Follow-up at week 0, 12, 24, 36, and 48
measure: Hemoglobin A1c (HbA1c)
timeFrame: Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period.
measure: HbA1c at Follow-up
timeFrame: Follow-up at Week 0, 12, 24, 36, and 48
measure: Body Weight
timeFrame: Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period
measure: Body Weight at Follow-up
timeFrame: Follow-up at Week 0, 12, 24, 36, and 48
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: