Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Alogliptin Combined With Pioglitazone in Subjects With Type 2 Diabetes Mellitus

NCT00286494

Diabetes Mellitus

COMPLETED PHASE3

Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus.

NCT00328627

Type 2 Diabetes Mellitus

COMPLETED PHASE3

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

NCT01318070

Type 2 Diabetes Mellitus

COMPLETED PHASE2/PHASE3

Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes.

NCT00755846

Diabetes Mellitus

COMPLETED PHASE2

Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes

NCT01289119

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

SYR-322 (alogliptin) is a selective, orally available inhibitor of dipeptidyl peptidase IV being developed as a treatment for type 2 diabetes mellitus. Dipeptidyl peptidase IV is the primary enzyme involved in the in vivo degradation of at least 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.

Pioglitazone HCl (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. (Osaka, Japan). Pioglitazone HCl depends on the presence of insulin for its mechanism of action.

This study will assess the effects of alogliptin and alogliptin coadministered with pioglitazone HCl on postprandial lipid and lipoprotein metabolism in participants with type 2 diabetes. Individuals who participate in this study will be required to commit to a screening visit and up to 6 additional visits at the study center. Study participation is anticipated to be about 20 weeks (or approximately 5 months). Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations and electrocardiograms. At 3 of the visits a meal will be served that must be eaten within 10 minutes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo QD

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.

Alogliptin 25 mg QD

Group Type EXPERIMENTAL

Alogliptin

Intervention Type DRUG

Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.

Alogliptin 25 mg QD + Pioglitazone 30 mg QD

Group Type EXPERIMENTAL

Alogliptin and Pioglitazone

Intervention Type DRUG

Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alogliptin and Pioglitazone

Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.

Intervention Type DRUG

Alogliptin

Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.

Intervention Type DRUG

Placebo

Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

alogliptin SYR110322 Actos AD-4833 SYR-322 SYR110322 SYR-322 Actos AD-4833 SYR-322

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No