Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes
An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Determine the Efficacy and Safety of SYR-322 When Used in Subjects With Type 2 Diabetes
3 other identifiers
interventional
506
3 countries
21
Brief Summary
The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes-mellitus-type-2
Started Dec 2010
Shorter than P25 for phase_3 diabetes-mellitus-type-2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 1, 2011
CompletedFirst Posted
Study publicly available on registry
February 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
March 22, 2013
CompletedMarch 22, 2013
February 1, 2013
1 year
February 1, 2011
February 17, 2013
February 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.
Baseline and Week 16.
Secondary Outcomes (11)
Change From Baseline in HbA1c Over Time
Baseline and Weeks 4, 8 and 12.
Change From Baseline in Fasting Plasma Glucose Over Time
Baseline and Weeks 4, 8, 12 and 16.
Percentage of Participants With Marked Hyperglycemia
Randomization to Week 16.
Change From Baseline in Body Weight
Baseline and Weeks 8 and 16.
Percentage of Participants With HbA1c ≤6.5% at Week 16
Week 16
- +6 more secondary outcomes
Study Arms (6)
Placebo
PLACEBO COMPARATORParticipants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
Alogliptin Monotherapy
EXPERIMENTALParticipants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
Metformin
OTHERParticipants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
Metformin + Alogliptin Add-on Therapy
EXPERIMENTALParticipants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
Pioglitazone
OTHERParticipants continued to receive their stable dose of pioglitazone with or without metformin, and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
Pioglitazone + Alogliptin Add-on Therapy
EXPERIMENTALParticipants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
Interventions
Alogliptin tablets
Stable metformin dose
Stable pioglitazone dose
Eligibility Criteria
You may qualify if:
- Has a historical diagnosis of Type 2 Diabetes Mellitus.
- Has a body mass index between acceptable range.
- Is experiencing inadequate glycemic control.
- Body weight keeps constant.
- Females of childbearing potential and males who are sexually active agree to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose.
You may not qualify if:
- Has participated in another clinical study within the past 90 days or has received any investigational compound within 30 days prior to randomization.
- Has a systolic blood pressure beyond the acceptable range at Screening visit.
- Has New York Heart Association Class III or IV heart failure regardless of therapy.
- Has any major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
- Has a history of hypersensitivity or allergies to any DPP-4 inhibitor.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (21)
Unknown Facility
Beijing, Beijing Municipality, China
Unknown Facility
Fuzhou, Fujian, China
Unknown Facility
Xiamen, Fujian, China
Unknown Facility
Guangzhou, Guangdong, China
Unknown Facility
Haikou, Hainan, China
Unknown Facility
Harbin, Heilongjiang, China
Unknown Facility
Jingzhou, Hubei, China
Unknown Facility
Shiyan, Hubei, China
Unknown Facility
Changsha, Hunan, China
Unknown Facility
Wuxi, Jiangsu, China
Unknown Facility
Nanchang, Jiangxi, China
Unknown Facility
Changchun, Jilin, China
Unknown Facility
Shenyang, Liaoning, China
Unknown Facility
Jinan, Shandong, China
Unknown Facility
Shanghai, Shanghai Municipality, China
Unknown Facility
Xi’an, Shanxi, China
Unknown Facility
Tianjin, Tianjin Municipality, China
Unknown Facility
Kunming, Yunnan, China
Unknown Facility
Hangzhou, Zhejiang, China
Unknown Facility
Hong Kong, Hong Kong, Hong Kong
Unknown Facility
Taipei County, Taiwan
Related Publications (1)
El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.
PMID: 38837240DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. VP, Clinical Science
- Organization
- Takeda Global Research and Development Center, Inc.
Study Officials
- STUDY CHAIR
Professor Study Chair
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2011
First Posted
February 3, 2011
Study Start
December 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 22, 2013
Results First Posted
March 22, 2013
Record last verified: 2013-02