Type 2 Diabetes MellitusPhase 2/3NCT01318109

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

A Phase 2/3 study testing Alogliptin and metformin and Metformin in people with Type 2 Diabetes Mellitus, run by Takeda.

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 evaluate the efficacy and safety of alogliptin, once dairy (QD) combined with metformin taken twice daily (BID) or three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose. Read more about this study

Who is it for?: Ages 26 to 64 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Alogliptin and metformin and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 288 participants
Where: No sites listed yet
Study dates: Aug 2008to Apr 2009
Phase: Phase 2/3
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 26 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
Was receiving specific diet and exercise (if any) therapies during the observation period.

Who cannot join

Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0).
With a history or symptoms of lactic acidosis.

About this study

Official title: A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Metformin 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.

The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to metformin in type 2 diabetic patients who have uncontrolled blood glucose despite treatment with metformin as well as diet and exercise therapies.

Conditions: Type 2 Diabetes Mellitus
Being tested: Alogliptin and metformin, Metformin
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.

Alogliptin and metforminDrug
Also called SYR-32, Glycoran
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
Alogliptin and metforminDrug
Also called SYR-322, Glycoran
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
MetforminDrug
Also called Glycoran
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.

Study groups in NCT01318109
Study group	Role	What they receive
Alogliptin 12.5 mg QD and metformin 500mg BID or 750mg TID	Active comparator	Not described Receives: Drug: Alogliptin and metformin
Alogliptin 25mg QD and metformin 500mg BID or 750mg TID	Active comparator	Not described Receives: Drug: Alogliptin and metformin
Metformin 500mg BID or 750mg TID	Active comparator	Not described Receives: Drug: Metformin

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 (8)

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 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 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 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 baseline.
Measured: Baseline and Week 12.
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).
The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 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.

Aug 2008Apr 2009

First posted18 Mar 2011 (estimated)
Study startAug 2008
Primary completionApr 2009
Study completionApr 2009

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 Type 2 Diabetes MellitusStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 288 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01318109
Sponsor's protocol ID: SYR-322/CCT-006
Other IDs: JapicCTI-080629, UMIN000001394, U1111-1119-6303
Status last verified: Feb 2012
First submitted: 16 Mar 2011
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?

Official record

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All Type 2 Diabetes Mellitus trials

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 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Metformin in Subjects With Type 2 Diabetes in Japan
ClinicalTrials.gov ID: NCT01318109
Acronym / sponsor ID: SYR-322/CCT-006
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus - Type 2, Diabetes Mellitus, Drug Therapy
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 288 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 18 Mar 2011 (estimated)
Results: Posted 11 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Alogliptin 12.5 mg QD and metformin 500mg BID or 750mg TID	Active comparator	Drug: Alogliptin and metformin
Alogliptin 25mg QD and metformin 500mg BID or 750mg TID	Active comparator	Drug: Alogliptin and metformin
Metformin 500mg BID or 750mg TID	Active comparator	Drug: Metformin

Who may qualify

Ages: 26 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
Was receiving specific diet and exercise (if any) therapies during the observation period.

Key exclusion criteria (2 listed)

Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0).
With a history or symptoms of lactic acidosis.

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
Alogliptin and metforminAlso: SYR-32, GlycoranAlogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.	Drug	Alogliptin 12.5 mg QD and metformin 500mg BID or 750mg TID
Alogliptin and metforminAlso: SYR-322, GlycoranAlogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.	Drug	Alogliptin 25mg QD and metformin 500mg BID or 750mg TID
MetforminAlso: GlycoranMetformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.	Drug	Metformin 500mg BID or 750mg TID

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.

8 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 Blood Glucose Measured by the Meal Tolerance Test (Week 12).
Time frame: Baseline and Week 12.

Results and safety

Results posted to the registry on 11 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
Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID	92	91
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID	96	93
Metformin 500mg BID or 750mg TID	100	100

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	Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID n = 92	Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID n = 96	Metformin 500mg BID or 750mg TID n = 100
Value	-0.54 (0.562)	-0.64 (0.488)	0.21 (0.641)

Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID vs Metformin 500mg BID or 750mg TID: Mean Difference (Final Values): -0.751 (95% CI -0.923 to -0.579)
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID vs Metformin 500mg BID or 750mg TID: Mean Difference (Final Values): -0.858 (95% CI -1.019 to -0.697)

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.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID	0 of 92 (0%)	32 of 92 (34.8%)	Not reported
Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID	2 of 96 (2.1%)	37 of 96 (38.5%)	Not reported
Metformin 500mg BID or 750mg TID	0 of 100 (0%)	29 of 100 (29%)	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, Diabetes and Endocrine Division study director

Department of Medicine, Kawasaki Medical School

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Alogliptin and metformin and Metformin in people with Type 2 Diabetes Mellitus, 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 4 inclusion and 2 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.

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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 11 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 NCT01318109.

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.