Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes.
Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing SYR-322 Alone and Combination SYR-322 With Pioglitazone Versus Placebo on Postprandial Lipids in Subjects With Type 2 Diabetes
4 other identifiers
interventional
71
2 countries
2
Brief Summary
The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes-mellitus
Started Jul 2007
Typical duration for phase_3 diabetes-mellitus
2 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
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 4, 2008
CompletedFirst Posted
Study publicly available on registry
April 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
May 27, 2013
CompletedMay 27, 2013
May 1, 2013
2.4 years
April 4, 2008
February 17, 2013
May 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16.
The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline.
Baseline and Week 16.
Secondary Outcomes (17)
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4.
Baseline and Week 4.
Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters.
Baseline, Week 4 and Week 16.
Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters.
Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1)
Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucose
Baseline, Week 4 and Week 16.
- +12 more secondary outcomes
Study Arms (3)
Placebo QD
PLACEBO COMPARATORAlogliptin 25 mg QD
EXPERIMENTALAlogliptin 25 mg QD + Pioglitazone 30 mg QD
EXPERIMENTALInterventions
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
Eligibility Criteria
You may qualify if:
- Diagnosis of type 2 diabetes
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Either failed treatment with diet and exercise for 3 months prior to Screening or has been receiving a stable dose of metformin, sulfonylurea, nateglinide, or repaglinide for more than 3 months prior to Screening.
- Inadequate glycemic control as defined by glycosylated hemoglobin concentration between 6.5 and 9.0%, inclusive.
- Fasting plasma glucose less than 13.3 mmol per L.
- Fasting serum triglyceride level of 1.7 to 5.0 mmol per L, inclusive.
- Has not been receiving any lipid-lowering therapy within 3 months prior to Screening or on a stable statin and/or ezetimibe therapy (same drug and dose) for at least 3 months.
- Body mass index greater than 23 kg/m2 and less than 45 kg/m2.
- If has regular use of other, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. Use of as needed prescription medications and over-the-counter medications is allowed at the discretion of the investigator.
- Is to be Apolipoprotein E 3/3 or Apolipoprotein E 3/4 phenotype positive prior to baseline.
You may not qualify if:
- History of type 1 diabetes.
- History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years.
- Diastolic blood pressure greater than 100 mm Hg or a systolic blood pressure of greater than 160 mm Hg.
- History of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication.
- Hemoglobin less than 120 g per L for males and less than100 g per L for females.
- Alanine transaminase level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
- Serum creatinine level greater than 133 μmol per L.
- Fasting total cholesterol greater than 6.5 mmol per L.
- New York Heart Association heart failure of any Class (I-IV) regardless of therapy.
- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
- History of acute metabolic diabetic complications.
- History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
- History of infection with human immunodeficiency virus.
- History of diabetic gastro paresis.
- History of gastric bypass surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (2)
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Gothenburg, Sweden
Related Publications (1)
Eliasson B, Moller-Goede D, Eeg-Olofsson K, Wilson C, Cederholm J, Fleck P, Diamant M, Taskinen MR, Smith U. Lowering of postprandial lipids in individuals with type 2 diabetes treated with alogliptin and/or pioglitazone: a randomised double-blind placebo-controlled study. Diabetologia. 2012 Apr;55(4):915-25. doi: 10.1007/s00125-011-2447-3. Epub 2012 Jan 12.
PMID: 22237690RESULT
Related Links
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 DIRECTOR
Medical Director
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
April 4, 2008
First Posted
April 10, 2008
Study Start
July 1, 2007
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
May 27, 2013
Results First Posted
May 27, 2013
Record last verified: 2013-05