Diabetes Mellitus Clinical Trial
Official title:
A Multicenter, Double-Blind Study to Determine the Efficacy and Safety of SYR-322 Plus Pioglitazone HCl (Actos®), SYR-322 Alone or Pioglitazone HCl Alone in Subjects With Type 2 Diabetes
The purpose of this study is to evaluate the combination of alogliptin, once daily (QD), and pioglitazone in patients with type 2 diabetes mellitus who are inadequately controlled with diet and exercise alone.
There are approximately 19 million people in the United States who have been diagnosed with
diabetes mellitus, of which 90% to 95% is type 2. The prevalence of type 2 diabetes varies
among racial and ethnic populations and has been shown to correlate with age, obesity,
family history, history of gestational diabetes, and physical inactivity. Over the next
decade, a marked increase in the number of adults with diabetes mellitus is expected,
placing an ever-increasing burden on families and the health care system.
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
reaching 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.
As the rate of newly diagnosed cases of type 2 diabetes mellitus continues to grow, so does
the need for products that will provide better glycemic control and improved safety and
tolerability. Alogliptin and pioglitazone have complementary actions. Alogliptin inhibits
the degradation of glucagon-like peptide-1 by inhibiting the enzyme dipeptidyl peptidase IV,
thus augmenting glucose-dependent insulin secretion while pioglitazone is a peripheral and
hepatic insulin sensitizer. Given the complementary mechanisms of action of alogliptin
(stimulates insulin secretion) and pioglitazone (enhances insulin sensitivity), the addition
of combination therapy in treatment naïve type 2 diabetes patients may potentially allow the
patients to reach and maintain their glycosylated hemoglobin goal more effectively.
The aim of this study is to evaluate the effectiveness of the combination of alogliptin with
pioglitazone in patients who are inadequately controlled on diet and exercise alone. Study
participation is anticipated to be approximately 8.5 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03743779 -
Mastering Diabetes Pilot Study
|
||
Completed |
NCT03786978 -
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
|
N/A | |
Completed |
NCT01804803 -
DIgital Assisted MONitoring for DiabeteS - I
|
N/A | |
Completed |
NCT05039970 -
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04068272 -
Safety of Bosentan in Type II Diabetic Patients
|
Phase 1 | |
Completed |
NCT03243383 -
Readmission Prevention Pilot Trial in Diabetes Patients
|
N/A | |
Completed |
NCT03730480 -
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
|
N/A | |
Recruiting |
NCT02690467 -
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
|
N/A | |
Completed |
NCT02229383 -
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
|
Phase 3 | |
Completed |
NCT06181721 -
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT04489043 -
Exercise, Prediabetes and Diabetes After Renal Transplantation.
|
N/A | |
Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
Completed |
NCT03542084 -
Endocrinology Auto-Triggered e-Consults
|
N/A | |
Completed |
NCT02229396 -
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
|
Phase 3 | |
Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
Completed |
NCT05031000 -
Blood Glucose Monitoring Systems: Discounter Versus Brand
|
N/A | |
Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A |