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Postmarketing Clinical Study on AO-128

Primary Purpose

Impaired Glucose Tolerance (IGT)

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

AO-128

About this trial

This is an interventional treatment trial for Impaired Glucose Tolerance (IGT)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AO-128 0.6 mg

Arm Description

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

Outcomes

Primary Outcome Measures

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".

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".

Secondary Outcome Measures

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 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 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".

Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function

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

2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)

Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in the "Full Analysis Set."

2-Hour Plasma Glucose During 75 g OGTT at Follow-up

Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in participants who proceeded to the follow-up in the "Full Analysis Set."

Hemoglobin A1c (HbA1c)

Summary statistics were calculated at each assessment time point for the HbA1c in the "Full Analysis Set."

HbA1c at Follow-up

Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the "Full Analysis Set."

Body Weight

Summary statistics were calculated at each assessment time point for the body weight in the "Full Analysis Set."

Body Weight at Follow-up

Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the "Full Analysis Set."

Full Information

NCT ID

NCT02287402

First Posted

October 22, 2014

Last Updated

April 8, 2015

Sponsor

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT02287402

Brief Title

Postmarketing Clinical Study on AO-128

Official Title

Postmarketing Clinical Study on AO-128

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Takeda

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impaired Glucose Tolerance (IGT)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

197 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AO-128 0.6 mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AO-128

Other Intervention Name(s)

Voglibose, BASEN

Intervention Description

AO-128 tablet

Primary Outcome Measure Information:

Title

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

Description

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.

Title

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

Description

Time Frame

Follow-up at Week 12, 24, 36, and 48

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Day 168, 336, 504, and 672

Title

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

Description

Time Frame

Day 168, 336, 504, and 672

Title

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

Description

Time Frame

Day 168, 336, 504, and 672

Title

Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function

Description

Time Frame

Day 168, 336, 504, and 672

Title

2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)

Description

Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in the "Full Analysis Set."

Time Frame

Week 0, 24, 48, 72, 96, 120, and the end of the treatment period

Title

2-Hour Plasma Glucose During 75 g OGTT at Follow-up

Description

Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in participants who proceeded to the follow-up in the "Full Analysis Set."

Time Frame

Follow-up at week 0, 12, 24, 36, and 48

Title

Hemoglobin A1c (HbA1c)

Description

Summary statistics were calculated at each assessment time point for the HbA1c in the "Full Analysis Set."

Time Frame

Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period.

Title

HbA1c at Follow-up

Description

Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the "Full Analysis Set."

Time Frame

Follow-up at Week 0, 12, 24, 36, and 48

Title

Body Weight

Description

Summary statistics were calculated at each assessment time point for the body weight in the "Full Analysis Set."

Time Frame

Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period

Title

Body Weight at Follow-up

Description

Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the "Full Analysis Set."

Time Frame

Follow-up at Week 0, 12, 24, 36, and 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director Clinical Science

Organizational Affiliation

Takeda

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Postmarketing Clinical Study on AO-128

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