Clinical trial NCT00328627: Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus.
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of the Combination of SYR-322 (SYR110322) and Pioglitazone HCl (ACTOS®), in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus, Type 2
Drug Therapy
Diabetes Mellitus, Non Insulin Dependent
Glucose Intolerance
Hyperglycemia
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2006-05-22
Enrollment: 1554
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of alogliptin, once daily (QD), taken in combination with pioglitazone in adults with type 2 diabetes mellitus.

Detailed description: Over the past 30 years, the prevalence of diabetes has increased dramatically throughout the world due to population growth, aging, urbanization, increasing obesity, and physical inactivity. The total number of people with type 2 diabetes mellitus is projected to rise from 171 million in 2000 to 366 million in 2030. The incidence of type 2 diabetes mellitus in the United States alone is expected to increase from approximately 17 to 30.3 million by the year 2030. Type 2 diabetes mellitus is associated with a number of long-term microvascular and macrovascular complications associated with a reduced quality of life and increased morbidity and mortality. It is anticipated that the increasing incidence of type 2 diabetes mellitus will place an ever-increasing burden on families, increase national expenditures for health care services, and decrease worker productivity.

Current pharmacologic interventions for type 2 diabetes mellitus include a diverse range of antidiabetic medications with different mechanisms of action including insulin and insulin analogues, sulfonylureas, metformin, meglitinides, thiazolidinediones, inhibitors of alpha-glucosidase, analogs of glucagon-like peptide-1 and synthetic analogues of human amylin. Despite the variety of medications, many have clinically important or potentially life-threatening side effects, restricted use in many subpopulations, concerns with long-term tolerability, and challenges related to compliance due to side effects and route of administration. All of these reasons contribute to the difficulties patients have achieving the target glycosylated hemoglobin level less than 7%.

SYR-322 (alogliptin) is a selective, orally available inhibitor of the dipeptidyl peptidase-4 enzyme. Dipeptidyl peptidase-4 enzyme is thought to be primarily responsible for the in vivo degradation of 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. Both peptides exert important effects on islet beta cells to stimulate glucose-dependent insulin secretion as well as regulating beta cell proliferation and cytoprotection. Glucagon-like peptide-1, but not glucose-dependent insulinotropic peptide, inhibits gastric emptying, glucagon secretion, and food intake. Glucose-dependent insulinotropic peptide has been shown to enhance insulin secretion by direct interaction with a glucose-dependent insulinotropic peptide -specific receptor on islet beta cells. The glucose-lowering actions of glucagon-like peptide-1, but not glucose-dependent insulinotropic peptide, are preserved in patients with type 2 diabetes mellitus.

Pioglitazone (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. (Osaka, Japan) that is approved for the treatment of type 2 diabetes mellitus. Pioglitazone is a selective peroxisome proliferator-activated receptor-gamma agonist that decreases insulin resistance in the periphery and liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output.

Given the complementary mechanisms of action of alogliptin (stimulation of insulin secretion) and pioglitazone (enhancement of insulin sensitivity), the goal of this study is to evaluate the efficacy of the combination of alogliptin with pioglitazone in patients who are inadequately controlled on metformin. Study participation is anticipated to be approximately 7 months.

Eligibility criteria: Inclusion Criteria:

* Men or women with a historical diagnosis of type 2 diabetes mellitus who were treated with metformin greater than or equal to 1500 mg alone but were experiencing inadequate glycemic control.
* A stable dose of metformin of greater than or equal to 1500 mg or maximum tolerated dose.
* No treatment with antidiabetic agents other than metformin within the 2 months prior to Screening.
* A body mass index greater than or equal to 23 kg/m\^2 and less than or equal to 45 kg/m\^2.
* Fasting C-peptide greater than or equal to 0.8 ng/mL.
* Regular use of other, non-excluded medications was allowed if a stable dose had been established for at least 4 weeks prior to Screening.
* Systolic blood pressure less than or equal to 160 mmHg and diastolic pressure less than or equal to 100 mmHg.
* Hemoglobin greater than or equal to 12 g/dL for men and greater than or equal to 10 g/dL for women.
* Alanine aminotransferase less than or equal to 2.5 times the upper limit of normal.
* Serum creatinine less than 1.5 mg/dL for men and less than 1.4 mg/dL for women.
* Thyroid-stimulating hormone level less than or equal to the upper limit of the normal range and the subject was clinically euthyroid.
* 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.
* Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
* No major illness or debility that in the investigator's opinion prohibited the patient from completing the study.

Exclusion Criteria:

* Urine albumin/creatinine ratio greater than 113 mg/mmol at Screening.
* A history of cancer, other than squamous cell or basal cell carcinoma of the skin, that had not been in full remission for at least 5 years prior to Screening.
* A history of laser treatment for proliferative diabetic retinopathy within 6 months prior to Screening.
* A history of treated diabetic gastroparesis.
* New York Heart Association Class III or IV heart failure regardless of therapy.
* History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.
* History of any hemoglobinopathy.
* History of infection with hepatitis B, hepatitis C or human immunodeficiency virus.
* History of a psychiatric disorder that could have affected the patient's ability to participate in the study.
* History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
* A history of alcohol or substance abuse within 2 years prior to Screening.
* Receipt of any investigational drug within 30 days prior to Screening or a history of receipt of an investigational antidiabetic drug within 3 months prior to Screening.
* Previous participation in an investigational study of alogliptin.
* Hypersensitive to pioglitazone, alogliptin, or other excipients.

Primary outcomes:
measure: Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) (Grouped Analysis)
timeFrame: Baseline and Week 26
measure: Change From Baseline to Week 26 in HbA1c
timeFrame: Baseline and Week 26
Secondary outcomes:
measure: Change From Baseline in HbA1c Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 4, 8, 12, 16 and 20.
measure: Change From Baseline to Week 4 in HbA1c
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 8 in HbA1c
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 12 in HbA1c
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 16 in HbA1c
timeFrame: Baseline and Week 16
measure: Change From Baseline to Week 20 in HbA1c
timeFrame: Baseline and Week 20
measure: Change From Baseline in Fasting Plasma Glucose Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.
measure: Change From Baseline to Week 1 in Fasting Plasma Glucose
timeFrame: Baseline and Week 1
measure: Change From Baseline to Week 2 in Fasting Plasma Glucose
timeFrame: Baseline and Week 2
measure: Change From Baseline to Week 4 in Fasting Plasma Glucose
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 8 in Fasting Plasma Glucose
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 12 in Fasting Plasma Glucose
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 16 in Fasting Plasma Glucose
timeFrame: Baseline and Week 16
measure: Change From Baseline to Week 20 in Fasting Plasma Glucose
timeFrame: Baseline and Week 20
measure: Change From Baseline to Week 26 in Fasting Plasma Glucose
timeFrame: Baseline and Week 26
measure: Percentage of Participants With Marked Hyperglycemia (Grouped Analysis)
timeFrame: From Week 1 to Week 26
measure: Percentage of Participants With Marked Hyperglycemia
timeFrame: From Week 1 to Week 26
measure: Percentage of Participants Meeting Rescue Criteria (Grouped Analysis)
timeFrame: From Week 1 to Week 26.
measure: Percentage of Participants Meeting Rescue Criteria
timeFrame: From Week 1 to Week 26
measure: Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5% (Grouped Analysis)
timeFrame: Week 26
measure: Percentage of Participants With Glycosylated Hemoglobin ≤ 6.5%
timeFrame: Week 26
measure: Percentage of Participants With Glycosylated Hemoglobin ≤ 7.0% (Grouped Analysis)
timeFrame: Week 26
measure: Percentage of Participants With Glycosylated Hemoglobin ≤ 7%
timeFrame: Week 26
measure: Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5% (Grouped Analysis)
timeFrame: Week 26
measure: Percentage of Participants With Glycosylated Hemoglobin ≤ 7.5%
timeFrame: Week 26
measure: Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5% (Grouped Analysis)
timeFrame: Baseline and Week 26
measure: Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 0.5%
timeFrame: Baseline and Week 26
measure: Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1% (Grouped Analysis)
timeFrame: Baseline and Week 26
measure: Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1%
timeFrame: Baseline and Week 26
measure: Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5% (Grouped Analysis)
timeFrame: Baseline and Week 26
measure: Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 1.5%
timeFrame: Baseline and Week 26
measure: Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2.0% (Grouped Analysis)
timeFrame: Baseline and Week 26.
measure: Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥ 2%
timeFrame: Baseline and Week 26
measure: Change From Baseline in Fasting Proinsulin Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20 and 26.
measure: Change From Baseline to Week 4 in Fasting Proinsulin
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 8 in Fasting Proinsulin
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 12 in Fasting Proinsulin
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 16 in Fasting Proinsulin
timeFrame: Baseline and Week 16
measure: Change From Baseline to Week 20 in Fasting Proinsulin
timeFrame: Baseline and Week 20
measure: Change From Baseline to Week 26 in Fasting Proinsulin
timeFrame: Baseline and Week 26
measure: Change From Baseline in Insulin Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20 and 26.
measure: Change From Baseline to Week 4 in Insulin Levels
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 8 in Insulin Levels
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 12 in Insulin Levels
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 16 in Insulin Levels
timeFrame: Baseline and Week 16
measure: Change From Baseline to Week 20 in Insulin Levels
timeFrame: Baseline and Week 20
measure: Change From Baseline to Week 26 in Insulin Levels
timeFrame: Baseline and Week 26
measure: Change From Baseline in Proinsulin/Insulin Ratio Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20 and 26.
measure: Change From Baseline to Week 4 in Proinsulin/Insulin Ratio
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 8 in Proinsulin/Insulin Ratio
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 12 in Proinsulin/Insulin Ratio
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 16 in Proinsulin/Insulin Ratio
timeFrame: Baseline and Week 16
measure: Change From Baseline to Week 20 in Proinsulin/Insulin Ratio
timeFrame: Baseline and Week 20
measure: Change From Baseline to Week 26 in Proinsulin/Insulin Ratio
timeFrame: Baseline and Week 26
measure: Change From Baseline in C-peptide Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20 and 26.
measure: Change From Baseline to Week 4 in C-peptide Levels
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 8 in C-peptide Levels
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 12 in C-peptide Levels
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 16 in C-peptide Levels
timeFrame: Baseline and Week 16
measure: Change From Baseline to Week 20 in C-peptide Levels
timeFrame: Baseline and Week 20
measure: Change From Baseline to Week 26 in C-peptide Levels
timeFrame: Baseline and Week 26
measure: Change From Baseline in Total Cholesterol Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20 and 26.
measure: Change From Baseline to Week 4 in Total Cholesterol Levels
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 8 in Total Cholesterol Levels
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 12 in Total Cholesterol Levels
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 16 in Total Cholesterol Levels
timeFrame: Baseline and Week 16
measure: Change From Baseline to Week 20 in Total Cholesterol Levels
timeFrame: Baseline and Week 20
measure: Change From Baseline to Week 26 in Total Cholesterol Levels
timeFrame: Baseline and Week 26
measure: Change From Baseline in Low-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20 and 26.
measure: Change From Baseline to Week 4 in Low-Density Lipoprotein Cholesterol
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 8 in Low-Density Lipoprotein Cholesterol
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 16 in Low-Density Lipoprotein Cholesterol
timeFrame: Baseline and Week 16
measure: Change From Baseline to Week 20 in Low-Density Lipoprotein Cholesterol
timeFrame: Baseline and Week 20
measure: Change From Baseline to Week 26 in Low-Density Lipoprotein Cholesterol
timeFrame: Baseline and Week 26
measure: Change From Baseline in High-Density Lipoprotein Cholesterol Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20 and 26.
measure: Change From Baseline to Week 4 in High-Density Lipoprotein Cholesterol
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 8 in High-Density Lipoprotein Cholesterol
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 16 in High-Density Lipoprotein Cholesterol
timeFrame: Baseline and Week 16
measure: Change From Baseline to Week 20 in High-Density Lipoprotein Cholesterol
timeFrame: Baseline and Week 20
measure: Change From Baseline to Week 26 in High-Density Lipoprotein Cholesterol
timeFrame: Baseline and Week 26
measure: Change From Baseline in Triglycerides Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20 and 26.
measure: Change From Baseline to Week 4 in Triglyceride Levels
timeFrame: Baseline and Week 4
measure: Change From Baseline to Week 8 in Triglyceride Levels
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 12 in Triglyceride Levels
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 16 in Triglyceride Levels
timeFrame: Baseline and Week 16
measure: Change From Baseline to Week 20 in Triglyceride Levels
timeFrame: Baseline and Week 20
measure: Change From Baseline to Week 26 in Triglyceride Levels
timeFrame: Baseline and Week 26
measure: Change From Baseline in Free Fatty Acids Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26.
measure: Change From Baseline to Week 12 in Free Fatty Acids
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in Free Fatty Acids
timeFrame: Baseline and Week 26
measure: Change From Baseline in Plasminogen Activator Inhibitor-1 Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26.
measure: Change From Baseline to Week 12 in Plasminogen Activator Inhibitor-1
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in Plasminogen Activator Inhibitor-1
timeFrame: Baseline and Week 26
measure: Change From Baseline in High-sensitivity C-Reactive Protein Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26.
measure: Change From Baseline to Week 12 in High-sensitivity C-Reactive Protein
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in High-sensitivity C-Reactive Protein
timeFrame: Baseline and Week 26
measure: Change From Baseline in Adiponectin Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26.
measure: Change From Baseline to Week 12 in Adiponectin
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in Adiponectin
timeFrame: Baseline and Week 26
measure: Change From Baseline in Body Weight Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 8, 12, 20 and 26.
measure: Change From Baseline to Week 8 in Body Weight
timeFrame: Baseline and Week 8
measure: Change From Baseline to Week 12 in Body Weight
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 20 in Body Weight
timeFrame: Baseline and Week 20
measure: Change From Baseline to Week 26 in Body Weight
timeFrame: Baseline and Week 26
measure: Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26.
measure: Change From Baseline to Week 12 in Calculated HOMA Insulin Resistance
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in Calculated HOMA Insulin Resistance
timeFrame: Baseline and Week 26
measure: Change From Baseline in Homeostatic Model Assessment Beta Cell Function (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26
measure: Change From Baseline to Week 12 in Calculated HOMA Beta-cell Function
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in Calculated HOMA Beta-cell Function
timeFrame: Baseline and Week 26
measure: Change From Baseline in Apolipoprotein A1 Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26.
measure: Change From Baseline to Week 12 in Apolipoprotein A1
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in Apolipoprotein A1
timeFrame: Baseline and Week 26
measure: Change From Baseline in Apolipoprotein A2 Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26
measure: Change From Baseline to Week 12 in Apolipoprotein A2
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in Apolipoprotein A2
timeFrame: Baseline and Week 26
measure: Change From Baseline in Apolipoprotein B Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26
measure: Change From Baseline to Week 12 in Apolipoprotein B
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in Apolipoprotein B
timeFrame: Baseline and Week 26
measure: Change From Baseline in Apolipoprotein C-III Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26
measure: Change From Baseline to Week 12 in Apolipoprotein C-III
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in Apolipoprotein C-III
timeFrame: Baseline and Week 26
measure: Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26.
measure: Change From Baseline to Week 12 in NMR Lipid Fractionation Total Triglycerides
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in NMR Lipid Fractionation Total Triglycerides
timeFrame: Baseline and Week 26
measure: Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26
measure: Change From Baseline to Week 12 in VLDL / Chylomicron Particles
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in VLDL / Chylomicron Particles
timeFrame: Baseline and Week 26
measure: Change From Baseline in VLDL / Chylomicron Triglycerides Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26
measure: Change From Baseline to Week 12 in VLDL / Chylomicron Triglycerides
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in VLDL / Chylomicron Triglycerides
timeFrame: Baseline and Week 26
measure: Change From Baseline in VLDL Particles Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26
measure: Change From Baseline to Week 12 in VLDL Particles
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in VLDL Particles
timeFrame: Baseline and Week 26
measure: Change From Baseline in Mean VLDL Particle Size Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26
measure: Change From Baseline to Week 12 in Mean VLDL Particle Size
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in Mean VLDL Particle Size
timeFrame: Baseline and Week 26
measure: Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26
measure: Change From Baseline to Week 12 in IDL Particles
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in IDL Particles
timeFrame: Baseline and Week 26
measure: Change From Baseline in Low Density Lipoprotein (LDL) Particles Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26
measure: Change From Baseline to Week 12 in LDL Particles
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in LDL Particles
timeFrame: Baseline and Week 26
measure: Change From Baseline in Mean LDL Particle Size Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26
measure: Change From Baseline to Week 12 in Mean LDL Particle Size
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in Mean LDL Particle Size
timeFrame: Baseline and Week 26
measure: Change From Baseline in High Density Lipoprotein (HDL) Particles Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26.
measure: Change From Baseline to Week 12 in HDL Particles
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in HDL Particles
timeFrame: Baseline and Week 26
measure: Change From Baseline in Mean HDL Particle Size Over Time (Grouped Analysis)
timeFrame: Baseline and Weeks 12 and 26
measure: Change From Baseline to Week 12 in Mean HDL Particle Size
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 26 in Mean HDL Particle Size
timeFrame: Baseline and Week 26
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Columbiana
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Searcy
country: United States
state: Arkansas
city: Sherwood
country: United States
state: Arkansas
city: Burbank
country: United States
state: California
city: Foothill Ranch
country: United States
state: California
city: Irvine
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Temecula
country: United States
state: California
city: Tustin
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Hollywood
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Warner Robins
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Lafayette
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Waterloo
country: United States
state: Iowa
city: Munfordville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Marrero
country: United States
state: Louisiana
city: Elkridge
country: United States
state: Maryland
city: Prince Frederick
country: United States
state: Maryland
city: Towson
country: United States
state: Maryland
city: Marlborough
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Cadillac
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Livonia
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: North Las Vegas
country: United States
state: Nevada
city: Blackwood
country: United States
state: New Jersey
city: Trenton
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Statesville
country: United States
state: North Carolina
city: Gallipolis
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Clinton
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Allentown
country: United States
state: Pennsylvania
city: Altoona
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Alcoa
country: United States
state: Tennessee
city: Milan
country: United States
state: Tennessee
city: Morristown
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Carrollton
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Multiple Cities
country: Australia
city: Multiple Cities
country: Brazil
city: Multiple Cities
country: Bulgaria
city: Multiple Cities
country: Chile
city: Multiple Cities
country: Croatia
city: Multiple Cities
country: Estonia
city: Multiple Cities
country: Guatemala
city: Multiple Cities
country: India
city: Multiple Cities
country: Israel
city: Multiple Cities
country: Latvia
city: Multiple Cities
country: Mexico
city: Multiple Cities
country: New Zealand
city: Multiple Cities
country: Peru
city: Multiple Cities
country: Romania
city: Multiple Cities
country: Russian Federation
city: Multiple Cities
country: Serbia
city: Multiple Cities
country: South Africa
city: Multiple Cities
country: Ukraine
Study officials:
affiliation: Takeda
name: VP Biological Sciences
role: STUDY_DIRECTOR
References:
citation: DeFronzo RA, Burant CF, Fleck P, Wilson C, Mekki Q, Pratley RE. Efficacy and tolerability of the DPP-4 inhibitor alogliptin combined with pioglitazone, in metformin-treated patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 May;97(5):1615-22. doi: 10.1210/jc.2011-2243. Epub 2012 Mar 14.