Impaired Glucose Tolerance (IGT)Phase 4NCT02287402
Postmarketing Clinical Study on AO-128
A Phase 4 study testing AO-128 in people with Impaired Glucose Tolerance (IGT), run by Takeda.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Impaired Glucose Tolerance (IGT)
- What is being tested?
- AO-128
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Nov 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
About this study
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.
Read the 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.
- Conditions
- Impaired Glucose Tolerance (IGT)
- Being tested
- AO-128
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AO-128Drug
Also called Voglibose, BASEN
AO-128 tablet
| Study group | Role | What they receive |
|---|---|---|
| AO-128 0.6 mg | Experimental | One AO-128 0.2 mg tablet was taken orally 3 times a day before meals. Receives: Drug: AO-128 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: 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
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".
Measured: Day 168, 336, 504, and 672
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".
Measured: 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".
Measured: 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".
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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."
Measured: Follow-up at Week 0, 12, 24, 36, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startMar 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Impaired Glucose Tolerance (IGT)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287402
- Sponsor's protocol ID
- AO-128/OCT-910
- Other IDs
- JapicCTI-101004, U1111-1163-1618
- Status last verified
- Apr 2015
- First submitted
- 22 Oct 2014
- Last updated
- 9 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarketing Clinical Study on AO-128
- ClinicalTrials.gov ID
- NCT02287402
- Acronym / sponsor ID
- AO-128/OCT-910
- Conditions
- Impaired Glucose Tolerance (IGT)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Posted 9 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AO-128 0.6 mg | Experimental | Drug: AO-128One AO-128 0.2 mg tablet was taken orally 3 times a day before meals. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AO-128Also: Voglibose, BASENAO-128 tablet | Drug | AO-128 0.6 mg |
Primary outcome
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".
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".
10 secondary outcomes
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
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
Time to Improvement to Normoglycemia in the Treatment Period Calculated by the Kaplan-Meier Method
Time frame: Day 168, 336, 504, and 672
Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function
Time frame: Day 168, 336, 504, and 672
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
2-Hour Plasma Glucose During 75 g OGTT at Follow-up
Time frame: Follow-up at week 0, 12, 24, 36, and 48
Hemoglobin A1c (HbA1c)
Time frame: Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period.
HbA1c at Follow-up
Time frame: Follow-up at Week 0, 12, 24, 36, and 48
Body Weight
Time frame: Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period
Body Weight at Follow-up
Time frame: Follow-up at Week 0, 12, 24, 36, and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Clinical Science study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AO-128 in people with Impaired Glucose Tolerance (IGT), run by Takeda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.