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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-101004 | Other Identifier | JapicCTI | |
| U1111-1163-1618 | Registry Identifier | WHO |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AO-128 0.6 mg | Experimental | One AO-128 0.2 mg tablet was taken orally 3 times a day before meals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AO-128 | Drug | AO-128 tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
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Participants with impaired glucose tolerance (IGT) who had been non-responsive to diet therapy and exercise therapy receive one AO-128 0.2 mg tablet orally 3 times a day before meals.
Participants took part in the study at 30 investigative sites in Japan from 9 March 2010 to 15 November 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | AO-128 0.6 mg | One AO-128 0.2 mg tablet was taken orally 3 times a day before meals. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
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| Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | AO-128 0.6 mg | One AO-128 0.2 mg tablet was taken orally 3 times a day before meals. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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". | Full Analysis Set - All participants who received at least 1 dose of open-label study drug. | Posted | Number | participants | Treatment period: Up to 122 weeks. Treatment was to be ended when patients were assessed as Type 2 Diabetes Mellitus or normoglycemic. |
|
From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AO-128 0.6 mg | One AO-128 0.2 mg tablet was taken orally 3 times a day before meals. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hitoshi Onouchi | Japan Development Center, Pharmaceutical Development Division, Takeda Pharmaceutical Company Limited | +81-6-6204-5116 | hitoshi.onouchi@takeda.com |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C054577 | AO 128 |
| C102817 | voglibose |
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
|
| years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 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". | Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up. | Posted | Number | participants | Follow-up at Week 12, 24, 36, and 48 |
|
|
|
| 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". | Full Analysis Set - All participants who received at least 1 dose of open-label study drug. | Posted | Number | percentage of participants | Day 168, 336, 504, and 672 |
|
|
|
| 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". | Full Analysis Set - All participants who received at least 1 dose of open-label study drug. | Posted | Number | percentage of participants | Day 168, 336, 504, and 672 |
|
|
|
| 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". | Full Analysis Set - All participants who received at least 1 dose of open-label study drug. | Posted | Number | percentage of participants | Day 168, 336, 504, and 672 |
|
|
|
| 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". | Full Analysis Set - All participants who received at least 1 dose of open-label study drug. | Posted | Number | percentage of participants | Day 168, 336, 504, and 672 |
|
|
|
| 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." | Full Analysis Set - All participants who received at least 1 dose of open-label study drug. | Posted | Mean | Standard Deviation | mg/dL | Week 0, 24, 48, 72, 96, 120, and the end of the treatment period |
|
|
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| 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." | Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up. | Posted | Mean | Standard Deviation | mg/dL | Follow-up at week 0, 12, 24, 36, and 48 |
|
|
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| Secondary | Hemoglobin A1c (HbA1c) | Summary statistics were calculated at each assessment time point for the HbA1c in the "Full Analysis Set." | Full Analysis Set - All participants who received at least 1 dose of open-label study drug. | Posted | Mean | Standard Deviation | percent | Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period. |
|
|
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| 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." | Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up. | Posted | Mean | Standard Deviation | percent | Follow-up at Week 0, 12, 24, 36, and 48 |
|
|
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| Secondary | Body Weight | Summary statistics were calculated at each assessment time point for the body weight in the "Full Analysis Set." | Full Analysis Set - All participants who received at least 1 dose of open-label study drug. | Posted | Mean | Standard Deviation | kg | Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period |
|
|
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| 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." | Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up. | Posted | Mean | Standard Deviation | kg | Follow-up at Week 0, 12, 24, 36, and 48 |
|
|
|
| 15 |
| 197 |
| 165 |
| 197 |
| Sinusitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Herpes zoster oticus | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Gastroenteritis norovirus | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Laryngeal cancer stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
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| Nystagmus | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 15.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Calculus urinary | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
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| Calculus ureteric | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
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| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.
| Title | Measurements |
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| Title | Measurements |
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| Day 672 |
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| Title | Measurements |
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| Day 672 |
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| Title | Measurements |
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| Day 672 |
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| Title | Measurements |
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| Day 672 |
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| Title | Measurements |
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| Week 72 |
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| Week 96 |
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| Week 120 |
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| The end of the treatment period |
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| Title | Measurements |
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| Follow-up at Week 36 |
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| Follow-up at Week 48 |
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| Title | Measurements |
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| Week 48 |
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| Week 72 |
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| Week 96 |
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| Week 120 |
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| The end of the treatment period |
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| Title | Measurements |
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| Follow-up at Week 36 |
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| Follow-up at Week 48 |
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| Title |
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| Measurements |
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| Week 48 |
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| Week 72 |
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| Week 96 |
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| Week 120 |
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| The end of the treatment period |
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| Title | Measurements |
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| Follow-up at Week 36 |
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| Follow-up at Week 48 |
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