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Postmarketing Clinical Study on AO-128

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02287402
Recruitment Status : Completed
First Posted : November 10, 2014
Results First Posted : April 9, 2015
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment Phase
Impaired Glucose Tolerance (IGT) Drug: AO-128 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Postmarketing Clinical Study on AO-128
Study Start Date : March 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Arm Intervention/treatment
Experimental: AO-128 0.6 mg
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
Drug: AO-128
AO-128 tablet
Other Names:
  • Voglibose
  • BASEN




Primary Outcome Measures :
  1. Assessment of Diabetic Status in the Treatment Period (Type 2 Diabetes Mellitus, Normoglycemia, or Impaired Glucose Tolerance (IGT) [ Time Frame: Treatment period: Up to 122 weeks. Treatment was to be ended when patients were assessed as Type 2 Diabetes Mellitus or normoglycemic. ]
    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".

  2. Assessment of Diabetic Status in Follow-up (Type 2 Diabetes Mellitus, Normoglycemia, or IGT) [ Time Frame: Follow-up at Week 12, 24, 36, and 48 ]
    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 :
  1. Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated by the Kaplan-Meier Method [ Time Frame: Day 168, 336, 504, and 672 ]
    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".

  2. Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated Using the Cumulative Incidence Function [ Time Frame: Day 168, 336, 504, and 672 ]
    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".

  3. Time to Improvement to Normoglycemia in the Treatment Period Calculated by the Kaplan-Meier Method [ Time Frame: Day 168, 336, 504, and 672 ]
    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".

  4. Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function [ Time Frame: Day 168, 336, 504, and 672 ]
    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".

  5. 2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT) [ Time Frame: Week 0, 24, 48, 72, 96, 120, and the end of the treatment period ]
    Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in the "Full Analysis Set."

  6. 2-Hour Plasma Glucose During 75 g OGTT at Follow-up [ Time Frame: Follow-up at week 0, 12, 24, 36, and 48 ]
    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."

  7. Hemoglobin A1c (HbA1c) [ Time Frame: Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period. ]
    Summary statistics were calculated at each assessment time point for the HbA1c in the "Full Analysis Set."

  8. HbA1c at Follow-up [ Time Frame: Follow-up at Week 0, 12, 24, 36, and 48 ]
    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."

  9. Body Weight [ Time Frame: Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period ]
    Summary statistics were calculated at each assessment time point for the body weight in the "Full Analysis Set."

  10. Body Weight at Follow-up [ Time Frame: Follow-up at Week 0, 12, 24, 36, and 48 ]
    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."



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287402


Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Clinical Science Takeda
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02287402    
Other Study ID Numbers: AO-128/OCT-910
JapicCTI-101004 ( Other Identifier: JapicCTI )
U1111-1163-1618 ( Registry Identifier: WHO )
First Posted: November 10, 2014    Key Record Dates
Results First Posted: April 9, 2015
Last Update Posted: April 9, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Voglibose
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action