Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study

ABSTRACT Objectives: To evaluate the efficacy and safety of alogliptin in patients with type 2 diabetes inadequately controlled by therapy with a thiazolidinedione (TZD). Research design and methods: In a multicenter, double-blind, placebo-controlled clinical study, 493 patients 18-80 years old with...

Full description

Saved in:
Bibliographic Details
Published in:Current medical research and opinion 2009-10, Vol.25 (10), p.2361-2371
Main Authors: Pratley, Richard E., Reusch, Jane E.-B., Fleck, Penny R., Wilson, Craig A., Mekki, Qais
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Aged, 80 and over
Alogliptin
Blood Glucose - analysis
Diabetes Mellitus, Type 2 - drug therapy
Dipeptidyl peptidase-4 inhibitor
Dipeptidyl-Peptidase IV Inhibitors - adverse effects
Dipeptidyl-Peptidase IV Inhibitors - therapeutic use
Double-Blind Method
Female
Glycated Hemoglobin A - analysis
Glycemic control
Humans
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - therapeutic use
Male
Middle Aged
Piperidines - administration & dosage
Piperidines - adverse effects
Piperidines - therapeutic use
Placebos
Thiazolidinedione
Thiazolidinediones - administration & dosage
Thiazolidinediones - therapeutic use
Type 2 diabetes
Uracil - administration & dosage
Uracil - adverse effects
Uracil - analogs & derivatives
Uracil - therapeutic use
Young Adult
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:ABSTRACT Objectives: To evaluate the efficacy and safety of alogliptin in patients with type 2 diabetes inadequately controlled by therapy with a thiazolidinedione (TZD). Research design and methods: In a multicenter, double-blind, placebo-controlled clinical study, 493 patients 18-80 years old with inadequate glycemic control after stabilization (i.e., glycosylated hemoglobin [HbA1c] 7.0-10.0%) despite ongoing treatment with a TZD were randomly assigned (2:2:1) to treatment with pioglitazone plus alogliptin 12.5 mg, alogliptin 25 mg or placebo once daily. Concomitant therapy with metformin or sulfonylurea at prestudy doses was permitted. Main outcome measures: The primary efficacy endpoint was change in HbA1c from baseline to Week 26. Secondary endpoints included changes in fasting plasma glucose (FPG) and body weight, and incidences of marked hyperglycemia (FPG ≥ 200 mg/dL [11.10 mmol/L]) and rescue for hyperglycemia. Results: Least squares (LS) mean change in HbA1c was significantly (p 
ISSN:0300-7995
1473-4877
DOI:10.1185/03007990903156111