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Completed

NCT Number: NCT02287402

Postmarketing Clinical Study on AO-128

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.

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Key information

Conditions

Impaired Glucose Tolerance (IGT) Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AO-128

Drug

AO-128 tablet

Other names: Voglibose, BASEN

Primary outcomes

  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 outcomes

  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."

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 10, 2014
Registry last updated
Apr 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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