Postmarketing Clinical Study on AO-128

NCT02287402 | Completed Phase 4 Results

• 3 other identifiers: AO-128/OCT-910JapicCTI-101004U1111-1163-1618
• Study Type: interventional
• Target: 197
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Impaired Glucose Tolerance (IGT)

Outcome Measures

Primary Outcomes (2)

• 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.

• 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

Secondary Outcomes (10)

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

  Day 168, 336, 504, and 672

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

  Day 168, 336, 504, and 672

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

  Day 168, 336, 504, and 672

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

  Day 168, 336, 504, and 672

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

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

Study Arms (1)

AO-128 0.6 mg

EXPERIMENTAL

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

Drug: AO-128

Interventions

AO-128 DRUG

AO-128 tablet

Also known as: Voglibose, BASEN

AO-128 0.6 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \) Comorbid hypertension or high normal blood pressure
• \) Comorbid dyslipidemia
• \) Comorbid obesity
• \) 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Glucose Intolerance

Interventions

AO 128; voglibose

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Hitoshi Onouchi
• Organization: Japan Development Center, Pharmaceutical Development Division, Takeda Pharmaceutical Company Limited

hitoshi.onouchi@takeda.com

+81-6-6204-5116

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: November 10, 2014
• Study Start: March 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 9, 2015
• Results First Posted: April 9, 2015

Record last verified: 2015-04