Impaired Glucose ToleranceNCT01993927

Voglibose Tablets 0.2 / OD Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance"

An observational study of Impaired Glucose Tolerance, run by Takeda at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent progression to type 2 diabetes mellitus in participants with impaired glucose tolerance in the routine clinical setting. Read more about this study

Who is it for?: Any age
Conditions the study is for: Impaired Glucose Tolerance
What is being tested?: Voglibose
Type of treatment: Pill or oral medicine
How many people: 742 participants
Where: 1 siteJapan
Study dates: 18 Nov 2009to 31 Aug 2013
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Participants with impaired glucose tolerance

Who may be able to join

Participants must meet all of the following criteria ([1] to [3]) to be included in this study:
Determined as having IGT (defined as fasting blood glucose < 126 mg/dL and 2-hour post 75-g oral glucose tolerance test [OGTT] blood glucose of 140-199 mg/dL) without improvement despite treatment with diet therapy and exercise therapy for 3-6 months
Meets any of the following conditions:
Concurrently has hypertension*1 (ii) Concurrently has dyslipidemia*2 (iii) Is obese (BMI ≥25 kg/m^2) (iv) Has a family history of diabetes mellitus in relatives to the second degree as defined by Japanese law*3
Regularly visits the study site and can be observed for 72 weeks
1: Hypertension: Patients with systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, or patients on oral antihypertensive medication.

Show all 10Show fewer

2: Dyslipidaemia: Participants with any of the following conditions or participants on oral antidyslipidemic medication
Hyper LDL cholesterolemia (fasting LDL-cholesterol ≥140 mg/dL)
Hypo HDL cholesterolemia (fasting HDL-cholesterol < 40 mg/dL)
Hypertriglyceridemia (fasting triglyceride ≥150 mg/dL) *3: Relatives to the second degree of consanguinity refer to blood relatives who are the subject's "father or mother, grandfather or grandmother, brothers or sisters, children, or grandchildren." Note that these do not include spouse's relatives.

Who cannot join

Participants meeting either of the following criteria ([1] or [2]) will be excluded:
Previously diagnosed with diabetes mellitus
Has any contraindications to Basen as specified below:
Severe ketosis, diabetic coma or precoma (ii) Severe infection, perioperative state, or serious trauma (iii) History of hypersensitivity to any ingredients of Basen

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Osaka

Other trials in Japan

About this study

Official title: Voglibose Tablets 0.2 / Voglibose Oral Disintegrant (OD) Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance"

Read the detailed description

This is a special drug use surveillance on long-term use of Voglibose (Basen) designed to determine the safety and efficacy of long-term use of Voglibose (Basen) to prevent progression to type 2 diabetes mellitus in participants with impaired glucose tolerance in the routine clinical setting.

Particioants will be patients with impaired glucose tolerance. The planned sample size is 1,000.

The usual adult dosage is 0.2 mg of voglibose administered orally three times daily immediately before each meal.

Conditions: Impaired Glucose Tolerance
Being tested: Voglibose
Keywords: Drug Therapy
Medical subject headings: Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VogliboseDrug
Also called Basen Tablets, AO-128
Voglibose Tablets / Voglibose OD Tablets

Study groups in NCT01993927
Study group	Role	What they receive
Voglibose 0.2 mg or OD Tablets 0.2 mg		Voglibose 0.2 mg or OD Tablets 0.2 mg will be administered orally three times daily immediately before each meal. Receives: Drug: Voglibose

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experience at Least One Adverse Events
Measured: Up to Week 72
Percentage of Participants With Progression to Type 2 Diabetes Mellitus (T2DM) During Treatment Period
Percentage of participants who occurred progression of T2DM during treatment period was reported. Diagnostic criteria for progression of T2DM are: (1) "Blood glucose ≥200 mg/dL at any time, morning fasting blood glucose ≥126 mg/dL, or 2-hour post 75-g (Oral Glucose Tolerance Test) blood glucose ≥200 mg/dL. (2) Two or more glucose measurements obtained on different days that meet the above-mentioned criteria, or (3) A single glucose measurement meeting the above-mentioned criteria if the patient meets any of the following conditions: (i) Has typical symptoms of diabetes mellitus (e.g., dry mouth, polydipsia, polyuria, weight loss) (ii) HbA1C ≥6.5% (JDS value) (iii) Obvious diabetic retinopathy.
Measured: Up to Week 72

Secondary outcomes (1)

Percentage of Participants With Normalization of Impaired Glucose Tolerance (IGT) During Treatment Period
Percentage of participants who had normalization of Impaired Glucose Tolerance (IGT) during treatment period was reported. IGT normalization was determined by the survey physician based on the results of the 75-g oral glucose tolerance test (OGTT), glucose metabolism markers, and other data.
Measured: Up to Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 200931 Aug 2013

First posted25 Nov 2013 (estimated)
Study start18 Nov 2009
Primary completion31 Aug 2013
Study completion31 Aug 2013

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 ToleranceStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 742 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01993927
Sponsor's protocol ID: 340-012
Other IDs: JapicCTI-132304
Status last verified: Nov 2018
First submitted: 19 Nov 2013
Last updated: 4 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Impaired Glucose Tolerance trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Voglibose Tablets 0.2 / Voglibose Oral Disintegrant (OD) Tablets 0.2 Special Drug Use Surveillance "Long-term Use in Patients With Impaired Glucose Tolerance"
ClinicalTrials.gov ID: NCT01993927
Acronym / sponsor ID: 340-012
Conditions: Impaired Glucose Tolerance
Keywords: Drug Therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 742 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 18 Nov 2009 (actual)
Primary completion: 31 Aug 2013 (actual)
Study completion: 31 Aug 2013 (actual)
First posted: 25 Nov 2013 (estimated)
Results: Posted 2 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Particioants will be patients with impaired glucose tolerance. The planned sample size is 1,000.

The usual adult dosage is 0.2 mg of voglibose administered orally three times daily immediately before each meal.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Voglibose 0.2 mg or OD Tablets 0.2 mg	–	Drug: VogliboseVoglibose 0.2 mg or OD Tablets 0.2 mg will be administered orally three times daily immediately before each meal.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Participants with impaired glucose tolerance

Key inclusion criteria (10 listed)

Participants must meet all of the following criteria ([1] to [3]) to be included in this study:
Hyper LDL cholesterolemia (fasting LDL-cholesterol ≥140 mg/dL)
Hypo HDL cholesterolemia (fasting HDL-cholesterol < 40 mg/dL)
Hypertriglyceridemia (fasting triglyceride ≥150 mg/dL) *3: Relatives to the second degree of consanguinity refer to blood relatives who are the subject's "father or mother, grandfather or grandmother, brothers or sisters, children, or grandchildren." Note that these do not include spouse's relatives.

Key exclusion criteria (4 listed)

Participants meeting either of the following criteria ([1] or [2]) will be excluded:

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
VogliboseAlso: Basen Tablets, AO-128Voglibose Tablets / Voglibose OD Tablets	Drug	Voglibose 0.2 mg or OD Tablets 0.2 mg

Primary outcome

Number of Participants Who Experience at Least One Adverse Events
Time frame: Up to Week 72
Percentage of Participants With Progression to Type 2 Diabetes Mellitus (T2DM) During Treatment Period
Time frame: Up to Week 72
Percentage of participants who occurred progression of T2DM during treatment period was reported. Diagnostic criteria for progression of T2DM are: (1) "Blood glucose ≥200 mg/dL at any time, morning fasting blood glucose ≥126 mg/dL, or 2-hour post 75-g (Oral Glucose Tolerance Test) blood glucose ≥200 mg/dL. (2) Two or more glucose measurements obtained on different days that meet the above-mentioned criteria, or (3) A single glucose measurement meeting the above-mentioned criteria if the patient meets any of the following conditions: (i) Has typical symptoms of diabetes mellitus (e.g., dry mouth, polydipsia, polyuria, weight loss) (ii) HbA1C ≥6.5% (JDS value) (iii) Obvious diabetic retinopathy.

1 secondary outcome

Percentage of Participants With Normalization of Impaired Glucose Tolerance (IGT) During Treatment Period
Time frame: Up to Week 72

Results and safety

Results posted to the registry on 2 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Voglibose 0.2 mg or OD Tablets 0.2 mg	742	713

Primary outcome: Number of Participants Who Experience at Least One Adverse Events

Time frame: Up to Week 72. Count of participants. Unit: Participants

Measure	Voglibose 0.2 mg or OD Tablets 0.2 mg n = 713
Value	88

Population analysed: Safety/Efficacy Analysis Set was defined as all participants who were enrolled and completed the study. All data could be received as case report forms without major protocol violations.

Primary outcome: Percentage of Participants With Progression to Type 2 Diabetes Mellitus (T2DM) During Treatment Period

Time frame: Up to Week 72. Number. Unit: Percentage of participants

Measure	Voglibose 0.2 mg or OD Tablets 0.2 mg n = 708
Value	4.8

Population analysed: Safety/Efficacy Analysis Set was defined as all participants who were enrolled and completed the study. Reported data was collected from received case report forms including the data, without major protocol violations.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline up to Week 72. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Voglibose 0.2 mg or OD Tablets 0.2 mg	5 of 713 (0.7%)	39 of 713 (5.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Study Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Impaired Glucose Tolerance, run by Takeda at 1 site in Japan.

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 10 inclusion and 4 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 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2018). 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?

Number of Participants Who Experience at Least One Adverse Events (time frame: Up to Week 72). 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?

On the ClinicalTrials.gov record for NCT01993927.

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 4 Dec 2018.