Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328627
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2006-05-19
Brief Title:
Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus
Sponsor:
Takeda
Organization:
Takeda
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 303 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1113-8587 | REGISTRY | WHO | None |
| 2006-000694-30 | EUDRACT_NUMBER | None | None |