Postmarketing Clinical Study on AO-128

Impaired Glucose Tolerance (IGT) Clinical Trial

Official title:

Postmarketing Clinical Study on AO-128

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287402
• Other study ID #: AO-128/OCT-910
• Secondary ID: JapicCTI-101004U
• Status: Completed
• Phase: Phase 4
• First received: October 22, 2014
• Last updated: April 8, 2015
• Start date: March 2010
• Est. completion date: November 2012

Study information

• Verified date: April 2015
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance (IGT)

Intervention

Drug:
• AO-128
AO-128 tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	Treatment period: Up to 122 weeks. Treatment was to be ended when patients were assessed as Type 2 Diabetes Mellitus or normoglycemic.	No
Primary	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".	Follow-up at Week 12, 24, 36, and 48	No
Secondary	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".	Day 168, 336, 504, and 672	No
Secondary	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".	Day 168, 336, 504, and 672	No
Secondary	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".	Day 168, 336, 504, and 672	No
Secondary	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".	Day 168, 336, 504, and 672	No
Secondary	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."	Week 0, 24, 48, 72, 96, 120, and the end of the treatment period	No
Secondary	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."	Follow-up at week 0, 12, 24, 36, and 48	No
Secondary	Hemoglobin A1c (HbA1c)	Summary statistics were calculated at each assessment time point for the HbA1c in the "Full Analysis Set."	Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period.	No
Secondary	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."	Follow-up at Week 0, 12, 24, 36, and 48	No
Secondary	Body Weight	Summary statistics were calculated at each assessment time point for the body weight in the "Full Analysis Set."	Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period	No
Secondary	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."	Follow-up at Week 0, 12, 24, 36, and 48	No