Type 2 Diabetes MellitusPhase 2/3NCT01318135

Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan

A Phase 2/3 study testing Alogliptin and glimepiride and Alogliptin 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

Search all trials

Trial summary

To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID). Read more about this study

Who is it for?: Ages 20 to 64 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Alogliptin and glimepiride and Alogliptin and metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 576 participants
Where: No sites listed yet
Study dates: Jan 2009to Apr 2010
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 20 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:
Had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study.
Was capable of understanding and complying with protocol requirements.
Signed a written informed consent form prior to the initiation of any study procedure.

Who cannot join

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:
With clinical manifestation of hepatic impairment (eg, an aspartate aminotransferase or alanine aminotransferase value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
With clinical manifestation of renal impairment (eg, a creatinine value of 1.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
With serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease (eg, a subject who requires hospital admission).
Criteria that applied only to participants completing the core phase 2/3 metformin add-on study:
1. With history or symptoms of lactic acidosis.

About this study

Official title: A Long-term, Open-label Extension Study to Investigate the Long-term Safety of Alogliptin When Used in Combination With Sulfonylurea or Metformin in Subjects With Type 2 Diabetes in Japan

To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID).

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.

This was a phase 2/3, multicenter, open-label study, in participants who had completed the core phase 2/3 sulfonylurea add-on study (SYR-322/CCT-005; NCT01318083) or the core phase 2/3 metformin add-on study (SYR-322/CCT-006; NCT01318109) to evaluate the safety and efficacy of alogliptin administered as an add-on to a sulfonylurea (glimepiride) or metformin continuously for 40 weeks (52 weeks from the start of study treatment with alogliptin in the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).

Conditions: Type 2 Diabetes Mellitus
Being tested: Alogliptin and glimepiride, Alogliptin and 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 glimepirideDrug
Also called SYR-322, Amaryl
Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
Alogliptin and glimepirideDrug
Also called SYR-322, Amaryl
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
Alogliptin and metforminDrug
Also called SYR-322, Glycoran
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
Alogliptin and metforminDrug
Also called SYR-322, Glycoran
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Study groups in NCT01318135
Study group	Role	What they receive
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Active comparator	Not described Receives: Drug: Alogliptin and glimepiride
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Active comparator	Not described Receives: Drug: Alogliptin and glimepiride
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Active comparator	Not described Receives: Drug: Alogliptin and metformin
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID	Active comparator	Not described Receives: Drug: Alogliptin and metformin

What is being measured

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

Number of Participants With Adverse Events.
Treatment-emergent adverse events (TEAE) are defined as 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. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
Measured: 52 Weeks.

Secondary outcomes (30)

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 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 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 12.
Change From Baseline in Glycosylated Hemoglobin (Week 16).
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 16 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 16.
Change From Baseline in Glycosylated Hemoglobin (Week 20).
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 20 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 20.
Change From Baseline in Glycosylated Hemoglobin (Week 24).
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 24 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Glycosylated Hemoglobin (Week 28).
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 28 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 28.
Change From Baseline in Glycosylated Hemoglobin (Week 32).
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 32 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 32.
Change From Baseline in Glycosylated Hemoglobin (Week 36).
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 36 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 36.
Change From Baseline in Glycosylated Hemoglobin (Week 40).
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 40 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 40.
Change From Baseline in Glycosylated Hemoglobin (Week 44).
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 44 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 44.
Change From Baseline in Glycosylated Hemoglobin (Week 48).
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 48 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 48.
Change From Baseline in Glycosylated Hemoglobin (Week 52).
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 52 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 52.
Change From Baseline in Glycosylated Hemoglobin (Final Visit).
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 final visit and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Final Visit (up to 52).
Change From Baseline in Fasting Blood Glucose (Week 8).
The change between the value of fasting blood glucose collected at week 8 and baseline.
Measured: Baseline and Week 8.
Change From Baseline in Fasting Blood Glucose (Week 12).
The change between the value of fasting blood glucose collected at week 12 and baseline.
Measured: Baseline and Week 12.
Change From Baseline in Fasting Blood Glucose (Week 16).
The change between the value of fasting blood glucose collected at week 6 and baseline.
Measured: Baseline and Week 16.
Change From Baseline in Fasting Blood Glucose (Week 20).
The change between the value of fasting blood glucose collected at week 20 and baseline.
Measured: Baseline and Week 20.
Change From Baseline in Fasting Blood Glucose (Week 24).
The change between the value of fasting blood glucose collected at week 24 and baseline.
Measured: Baseline and Week 24.
Change From Baseline in Fasting Blood Glucose (Week 28).
The change between the value of fasting blood glucose collected at week 28 and baseline.
Measured: Baseline and Week 28.
Change From Baseline in Fasting Blood Glucose (Week 32).
The change between the value of fasting blood glucose collected at week 32 and baseline.
Measured: Baseline and Week 32.
Change From Baseline in Fasting Blood Glucose (Week 36).
The change between the value of fasting blood glucose collected at week 36 and baseline.
Measured: Baseline and Week 36.
Change From Baseline in Fasting Blood Glucose (Week 40).
The change between the value of fasting blood glucose collected at week 40 and baseline.
Measured: Baseline and Week 40.
Change From Baseline in Fasting Blood Glucose (Week 44).
The change between the value of fasting blood glucose collected at week 44 and baseline.
Measured: Baseline and Week 44.
Change From Baseline in Fasting Blood Glucose (Week 48).
The change between the value of fasting blood glucose collected at week 48 and baseline.
Measured: Baseline and Week 48.
Change From Baseline in Fasting Blood Glucose (Week 52).
The change between the value of fasting blood glucose collected at week 52 and baseline.
Measured: Baseline and Week 52.
Change From Baseline in Fasting Blood Glucose (Final Visit).
The change between the value of fasting blood glucose collected at final visit and baseline.
Measured: Baseline and Final Visit (up to Week 52).
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 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.
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).
The change between the value of blood glucose measured by the meal tolerance test collected at week 24 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 24.
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).
The change between the value of blood glucose measured by the meal tolerance test collected at week 52 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 52.
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).
The change between the value of blood glucose measured by the meal tolerance test collected at 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 Final Visit (up to Week 52).

Timeline

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

Jan 2009Apr 2010

First posted18 Mar 2011 (estimated)
Study startJan 2009
Primary completionJan 2010
Study completionApr 2010

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.
Publications (1)Papers the sponsor has linked to this study.
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: None (open label)
Enrolment: 576 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01318135
Sponsor's protocol ID: SYR-322/OCT-005
Other IDs: JapicCTI-090902, U1111-1119-6196
Status last verified: Jul 2012
First submitted: 16 Mar 2011
Last updated: 16 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Seino Y, Hiroi S, Hirayama M, Kaku K. Efficacy and safety of alogliptin added to sulfonylurea in Japanese patients with type 2 diabetes: A randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. J Diabetes Investig. 2012 Dec 20;3(6):517-25. doi: 10.1111/j.2040-1124.2012.00226.x. Epub 2012 Jul 12.
PubMed 24843617

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

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-term, Open-label Extension Study to Investigate the Long-term Safety of Alogliptin When Used in Combination With Sulfonylurea or Metformin in Subjects With Type 2 Diabetes in Japan
ClinicalTrials.gov ID: NCT01318135
Acronym / sponsor ID: SYR-322/OCT-005
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: 576 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Jan 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 18 Mar 2011 (estimated)
Results: Posted 16 Aug 2012

Clinical summary

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

To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID).

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: None (open label)
Number of arms: 4

Arm	Type	Receives
Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID	Active comparator	Drug: Alogliptin and glimepiride
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	Active comparator	Drug: Alogliptin and glimepiride
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	Active comparator	Drug: Alogliptin and metformin
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID	Active comparator	Drug: Alogliptin and metformin

Who may qualify

Ages: 20 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:
Had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study.
Was capable of understanding and complying with protocol requirements.
Signed a written informed consent form prior to the initiation of any study procedure.

Key exclusion criteria (6 listed)

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:
With clinical manifestation of hepatic impairment (eg, an aspartate aminotransferase or alanine aminotransferase value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
With clinical manifestation of renal impairment (eg, a creatinine value of 1.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
With serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease (eg, a subject who requires hospital admission).
Criteria that applied only to participants completing the core phase 2/3 metformin add-on study:

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 glimepirideAlso: SYR-322, AmarylAlogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Drug	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID
Alogliptin and glimepirideAlso: SYR-322, AmarylAlogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.	Drug	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID
Alogliptin and metforminAlso: SYR-322, GlycoranAlogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Drug	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID
Alogliptin and metforminAlso: SYR-322, GlycoranAlogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.	Drug	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID

Primary outcome

Number of Participants With Adverse Events.
Time frame: 52 Weeks.
Treatment-emergent adverse events (TEAE) are defined as 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. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.

30 secondary outcomes

Change From Baseline in Glycosylated Hemoglobin (Week 8).
Time frame: Baseline and Week 8.
Change From Baseline in Glycosylated Hemoglobin (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in Glycosylated Hemoglobin (Week 16).
Time frame: Baseline and Week 16.
Change From Baseline in Glycosylated Hemoglobin (Week 20).
Time frame: Baseline and Week 20.
Change From Baseline in Glycosylated Hemoglobin (Week 24).
Time frame: Baseline and Week 24.
Change From Baseline in Glycosylated Hemoglobin (Week 28).
Time frame: Baseline and Week 28.
Change From Baseline in Glycosylated Hemoglobin (Week 32).
Time frame: Baseline and Week 32.
Change From Baseline in Glycosylated Hemoglobin (Week 36).
Time frame: Baseline and Week 36.
Change From Baseline in Glycosylated Hemoglobin (Week 40).
Time frame: Baseline and Week 40.
Change From Baseline in Glycosylated Hemoglobin (Week 44).
Time frame: Baseline and Week 44.
Change From Baseline in Glycosylated Hemoglobin (Week 48).
Time frame: Baseline and Week 48.
Change From Baseline in Glycosylated Hemoglobin (Week 52).
Time frame: Baseline and Week 52.
Change From Baseline in Glycosylated Hemoglobin (Final Visit).
Time frame: Baseline and Final Visit (up to 52).
Change From Baseline in Fasting Blood Glucose (Week 8).
Time frame: Baseline and Week 8.
Change From Baseline in Fasting Blood Glucose (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in Fasting Blood Glucose (Week 16).
Time frame: Baseline and Week 16.
Change From Baseline in Fasting Blood Glucose (Week 20).
Time frame: Baseline and Week 20.
Change From Baseline in Fasting Blood Glucose (Week 24).
Time frame: Baseline and Week 24.
Change From Baseline in Fasting Blood Glucose (Week 28).
Time frame: Baseline and Week 28.
Change From Baseline in Fasting Blood Glucose (Week 32).
Time frame: Baseline and Week 32.
Change From Baseline in Fasting Blood Glucose (Week 36).
Time frame: Baseline and Week 36.
Change From Baseline in Fasting Blood Glucose (Week 40).
Time frame: Baseline and Week 40.
Change From Baseline in Fasting Blood Glucose (Week 44).
Time frame: Baseline and Week 44.
Change From Baseline in Fasting Blood Glucose (Week 48).
Time frame: Baseline and Week 48.
Change From Baseline in Fasting Blood Glucose (Week 52).
Time frame: Baseline and Week 52.
Change From Baseline in Fasting Blood Glucose (Final Visit).
Time frame: Baseline and Final Visit (up to Week 52).
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).
Time frame: Baseline and Week 24.
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).
Time frame: Baseline and Week 52.
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).
Time frame: Baseline and Final Visit (up to Week 52).

Results and safety

Results posted to the registry on 16 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CCT/005 - 12.5 mg Dose Group* → 12.5 mg Combination Group	99	97
CCT/005 - 25 mg Dose Group* → 25 mg Combination Dose Group	102	102
Glimepiride Monotherapy Group* → 12.5 mg Combination Group	46	46
Glimepiride Monotherapy Group* → 25 mg Combination Group	49	49
CCT/006 - 12.5 mg Dose Group* → 12.5 mg Combination Group	91	91
CCT/006 - 25 mg Dose Group* → 25 mg Combination Group	90	90
Metformin Monotherapy Group* → 12.5 mg Combination Group	50	50
Metformin Monotherapy Group* → 25 mg Combination Group	49	49

Primary outcome: Number of Participants With Adverse Events.

Time frame: 52 Weeks.. Number. Unit: participants

Measure	Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID n = 150	Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID n = 152	Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID n = 142	Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID n = 145
Serious Adverse Event	16	3	7	5
Other Adverse Event (≥3% Frequency Threshold)	116	134	108	113

Population analysed: Full Analysis Set was defined as the population of participants randomized in the core phase 2/3 SYR-322/CCT-005 (NCT01318083) or SYR-322/CCT-006 (NCT01318109) add-on studies and received at least 1 dose of the investigational products (SYR-322DB in combination with glimepiride or metformin) for the treatment period were identified for analysis.

30 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 Glimepiride 1- 6 mg QD or BID	16 of 150 (10.7%)	116 of 150 (77.3%)	Not reported
Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID	3 of 152 (2%)	134 of 152 (88.2%)	Not reported
Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID	7 of 142 (4.9%)	108 of 142 (76.1%)	Not reported
Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID	5 of 145 (3.4%)	113 of 145 (77.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24843617Seino Y, Hiroi S, Hirayama M, Kaku K. Efficacy and safety of alogliptin added to sulfonylurea in Japanese patients with type 2 diabetes: A randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. J Diabetes Investig. 2012 Dec 20;3(6):517-25. doi: 10.1111/j.2040-1124.2012.00226.x. Epub 2012 Jul 12.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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 glimepiride and Alogliptin 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 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 16 Aug 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 16 Aug 2012). 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 With Adverse Events. (time frame: 52 Weeks.). 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 NCT01318135, which also lists 1 linked publication.

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 16 Aug 2012.