Phase 4
Completed N=197
Postmarketing Clinical Study on AO-128
Impaired Glucose Tolerance (IGT)
Source: ClinicalTrials.gov NCT02287402 ↗
Enrolled (actual)
197
Serious AEs
7.6%
Results posted
Apr 2015
Primary outcomePrimary: Assessment of Diabetic Status in the Treatment Period (Type 2 Diabetes Mellitus, Normoglycemia, or Impaired Glucose Tolerance (IGT) — 25; 106; 66 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Diabetic Status in the Treatment Period (Type 2 Diabetes Mellitus, Normoglycemia, or Impaired Glucose Tolerance (IGT) |
25; 106; 66 | — |
| PRIMARY Assessment of Diabetic Status in Follow-up (Type 2 Diabetes Mellitus, Normoglycemia, or IGT) |
3; 9; 94 | — |
| SECONDARY Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated by the Kaplan-Meier Method |
0.0; 4.4; 10.2; 16.9 | — |
| SECONDARY Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated Using the Cumulative Incidence Function |
0.0; 3.3; 6.9; 10.0 | — |
| SECONDARY Time to Improvement to Normoglycemia in the Treatment Period Calculated by the Kaplan-Meier Method |
18.9; 37.5; 50.2; 60.3 | — |
| SECONDARY Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function |
18.9; 36.9; 48.4; 57.1 | — |
| SECONDARY 2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT) |
166.7; 148.0; 153.2; 155.6; 155.6; 163.2 | — |
| SECONDARY 2-Hour Plasma Glucose During 75 g OGTT at Follow-up |
119.4; 148.3; 147.9; 145.9; 138.3 | — |
| SECONDARY Hemoglobin A1c (HbA1c) |
5.45; 5.35; 5.30; 5.37; 5.34; 5.41 | — |
| SECONDARY HbA1c at Follow-up |
5.23; 5.27; 5.26; 5.20; 5.28 | — |
| SECONDARY Body Weight |
70.74; 69.74; 69.91; 69.25; 70.03; 69.25 | — |
| SECONDARY Body Weight at Follow-up |
67.60; 67.76; 68.87; 70.13; 68.72 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02287402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.