Diabetes Mellitus, Type 2Phase 2NCT01263470

Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan

A Phase 2 study testing Alogliptin and Voglibose in people with Diabetes Mellitus, Type 2, 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.

Official record

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Trial summary

The purpose of this study was to evaluate the dose-response relationships of alogliptin, once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal clinical dose for type 2 diabetic patients. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Alogliptin and Voglibose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 480 participants
Where: 1 siteJapan
Study dates: Jan 2007to Dec 2007
Phase: Phase 2
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

A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(Week -4).
A HbA1c differences within 10.0%* (*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.
Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).

Who cannot join

Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Okayama, 701-0192

Other trials in Japan

About this study

Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 in Subjects With Type 2 Diabetes in Japan

Read the detailed description

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

To evaluate the long-term safety and efficacy of alogliptin, participants in the present study could enter a long-term extension study SYR-322/OCT-001 (NCT01263496) that was planned separately.

Conditions: Diabetes Mellitus, Type 2
Being tested: Alogliptin, Voglibose, Placebo
Keywords: Diabetes Mellitus - Type 2, Diabetes Mellitus, Drug Therapy
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

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

AlogliptinDrug
Also called SYR-322
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
AlogliptinDrug
Also called SYR-322
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
AlogliptinDrug
Also called SYR-322
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
AlogliptinDrug
Also called SYR-322
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks
VogliboseDrug
Also called Voglib, BASEN®
Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
PlaceboDrug
Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.

Study groups in NCT01263470
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Alogliptin 6.25 mg QD	Experimental	Not described Receives: Drug: Alogliptin
Alogliptin 12.5 mg QD	Experimental	Not described Receives: Drug: Alogliptin
Alogliptin 25 mg QD	Experimental	Not described Receives: Drug: Alogliptin
Alogliptin 50 mg QD	Experimental	Not described Receives: Drug: Alogliptin
Voglibose 0.2 mg TID	Active comparator	Not described Receives: Drug: Voglibose

What is being measured

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

Change From Baseline in Glycosylated Hemoglobin (Week 12).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 12.

Secondary outcomes (16)

Change From Baseline in Glycosylated Hemoglobin (Week 2).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 2.
Change From Baseline in Glycosylated Hemoglobin (Week 4).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 4.
Change From Baseline in Glycosylated Hemoglobin (Week 8).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 8.
Change From Baseline in Fasting Plasma Glucose (Week 2).
The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 2
Change From Baseline in Fasting Plasma Glucose (Week 4).
The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 4.
Change From Baseline in Fasting Plasma Glucose (Week 8).
The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 8.
Change From Baseline in Fasting Plasma Glucose (Week 12).
The change between the value of fasting plasma glucose collected at week 12 or final visit and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 12.
Change From Baseline in Fasting C-peptide (Week 2).
The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.
Measured: Baseline and Week 2.
Change From Baseline in Fasting C-peptide (Week 4).
The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.
Measured: Baseline and Week 4.
Change From Baseline in Fasting C-peptide (Week 8).
The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.
Measured: Baseline and Week 8.
Change From Baseline in Fasting C-peptide (Week 12).
The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.
Measured: Baseline and Week 12.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).
The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.
Measured: Baseline and Week 12.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)).
The change between the value of blood glucose collected at week 12 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and at 2 hours after the start of the meal.
Measured: Baseline and Week 12.
Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)).
The change between the value of insulin collected at week 12 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 12
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).
The change between the value of C-peptide collected at week 12 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 12.
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).
The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 12

Timeline

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

Jan 2007Dec 2007

First posted20 Dec 2010 (estimated)
Study startJan 2007
Primary completionDec 2007
Study completionDec 2007

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 Diabetes Mellitus, Type 2Studies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 480 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01263470
Sponsor's protocol ID: SYR-322/CCT-001
Other IDs: U1111-1118-3752
Status last verified: Feb 2012
First submitted: 17 Dec 2010
Last updated: 3 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 in Subjects With Type 2 Diabetes in Japan
ClinicalTrials.gov ID: NCT01263470
Acronym / sponsor ID: SYR-322/CCT-001
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus - Type 2, Diabetes Mellitus, Drug Therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 480 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 20 Dec 2010 (estimated)
Results: Posted 6 Jul 2011

Clinical summary

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

Detailed description

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

To evaluate the long-term safety and efficacy of alogliptin, participants in the present study could enter a long-term extension study SYR-322/OCT-001 (NCT01263496) that was planned separately.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
Alogliptin 6.25 mg QD	Experimental	Drug: Alogliptin
Alogliptin 12.5 mg QD	Experimental	Drug: Alogliptin
Alogliptin 25 mg QD	Experimental	Drug: Alogliptin
Alogliptin 50 mg QD	Experimental	Drug: Alogliptin
Voglibose 0.2 mg TID	Active comparator	Drug: Voglibose

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(Week -4).
A HbA1c differences within 10.0%* (*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.
Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).

Key exclusion criteria (1 listed)

Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.

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
AlogliptinAlso: SYR-322Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Drug	Alogliptin 6.25 mg QD
AlogliptinAlso: SYR-322Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Drug	Alogliptin 12.5 mg QD
AlogliptinAlso: SYR-322Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Drug	Alogliptin 25 mg QD
AlogliptinAlso: SYR-322Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks	Drug	Alogliptin 50 mg QD
VogliboseAlso: Voglib, BASEN®Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	Drug	Voglibose 0.2 mg TID
PlaceboPlacebo-matching tablets, orally, once or three times daily for up to 12 weeks.	Drug	Placebo

Primary outcome

Change From Baseline in Glycosylated Hemoglobin (Week 12).
Time frame: Baseline and Week 12.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.

16 secondary outcomes

Change From Baseline in Glycosylated Hemoglobin (Week 2).
Time frame: Baseline and Week 2.
Change From Baseline in Glycosylated Hemoglobin (Week 4).
Time frame: Baseline and Week 4.
Change From Baseline in Glycosylated Hemoglobin (Week 8).
Time frame: Baseline and Week 8.
Change From Baseline in Fasting Plasma Glucose (Week 2).
Time frame: Baseline and Week 2
Change From Baseline in Fasting Plasma Glucose (Week 4).
Time frame: Baseline and Week 4.
Change From Baseline in Fasting Plasma Glucose (Week 8).
Time frame: Baseline and Week 8.
Change From Baseline in Fasting Plasma Glucose (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in Fasting C-peptide (Week 2).
Time frame: Baseline and Week 2.
Change From Baseline in Fasting C-peptide (Week 4).
Time frame: Baseline and Week 4.
Change From Baseline in Fasting C-peptide (Week 8).
Time frame: Baseline and Week 8.
Change From Baseline in Fasting C-peptide (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).
Time frame: Baseline and Week 12.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC (0-2)).
Time frame: Baseline and Week 12.
Change From Baseline in Insulin Measured by Meal Tolerance Testing - Area Under the Curve at 2 Hours (AUC(0-2)).
Time frame: Baseline and Week 12
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).
Time frame: Baseline and Week 12.
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 6 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	75	73
Alogliptin 6.25 mg QD	79	74
Alogliptin 12.5 mg QD	84	80
Alogliptin 25 mg QD	80	77
Alogliptin 50 mg QD	79	76
Voglibose 0.2 mg TID	83	78

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (Week 12).

Time frame: Baseline and Week 12.. Mean (Standard Deviation). Unit: percentage of Glycosylated Hemoglobin

Measure	Placebo n = 75	Alogliptin 6.25 mg QD n = 79	Alogliptin 12.5 mg QD n = 84	Alogliptin 25 mg QD n = 79	Alogliptin 50 mg QD n = 79	Voglibose 0.2 mg TID n = 83
Value	0.06 (0.456)	-0.51 (0.677)	-0.70 (0.572)	-0.76 (0.547)	-0.82 (0.474)	-0.16 (0.730)

Placebo vs Alogliptin 6.25 mg QD: Mean Difference (Final Values): -0.570 (95% CI -0.755 to -0.386)
Placebo vs Alogliptin 12.5 mg QD: Mean Difference (Final Values): -0.762 (95% CI -0.925 to -0.598)
Placebo vs Alogliptin 25 mg QD: Mean Difference (Final Values): -0.826 (95% CI -0.987 to -0.665)

Population analysed: Analysis based on last observation carried forward, where the last postbaseline double-blind observed value is carried forward and used for all subsequent scheduled time points where data is missing. Values are from the Full Analysis Set.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and the last dose of double-blind study drug.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 75 (1.3%)	20 of 75 (26.7%)	Not reported
Alogliptin 6.25 mg QD	2 of 79 (2.5%)	17 of 79 (21.5%)	Not reported
Alogliptin 12.5 mg QD	2 of 84 (2.4%)	23 of 84 (27.4%)	Not reported
Alogliptin 25 mg QD	1 of 80 (1.3%)	27 of 80 (33.8%)	Not reported
Alogliptin 50 mg QD	2 of 79 (2.5%)	23 of 79 (29.1%)	Not reported
Voglibose 0.2 mg TID	2 of 83 (2.4%)	38 of 83 (45.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
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.

Professor, Department of Medicine study director

Kawasaki Medical School

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alogliptin and Voglibose in people with Diabetes Mellitus, Type 2, 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 3 inclusion and 1 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 3 Feb 2012. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 6 Jul 2011). 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?

Change From Baseline in Glycosylated Hemoglobin (Week 12). (time frame: Baseline and Week 12.). 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 NCT01263470.

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 3 Feb 2012.