Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes

Takeda506 enrolled

Overview

The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin).

Diabetes is a chronic illness associated with microvascular complications such as nephropathy (kidney disease), retinopathy (eye damage) and neuropathy (nervous system damage). Diabetes is also associated with macrovascular complications including cardiovascular disease (heart disease), stroke and peripheral vascular disease (narrowing or blockage of blood vessels). These complications are associated with reduced quality of life and increased morbidity and mortality. Takeda is developing SYR-322 (alogliptin) for improvement of glycemic control in patients with Type 2 diabetes mellitus. Evaluations of alogliptin and its clinical efficacy have been conducted in multiple countries including the United States and Japan. This study will be conducted as a multi-center clinical trial in order to validate the efficacy and safety of alogliptin on type 2 diabetes population within Asia. Participants who qualified for the study were stratified into 1 of the 3 therapy groups based upon their background antidiabetic therapy before being randomized 1:1 to receive either alogliptin 25 mg once daily or matching placebo once daily. * Monotherapy group - patients who had been treated with diet and exercise for at least 2 months prior to screening. * Add-on to metformin therapy group - patients who had been treated with metformin for at least 3 months and at a stable dose (≥1000 mg/day) for at least 8 weeks prior to screening. * Add-on to pioglitazone therapy group - patients who had been treated with a stable dose of pioglitazone alone or in combination with metformin at a stable dose for at least 8 weeks prior to screening.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

506

Conditions

Diabetes Mellitus, Type 2

Interventions

AlogliptinDRUG

Alogliptin tablets

Placebo to alogliptinDRUG

Alogliptin placebo-matching tablets.

MetforminDRUG

Stable metformin dose

Pioglitazone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Has a historical diagnosis of Type 2 Diabetes Mellitus. * Has a body mass index between acceptable range. * Is experiencing inadequate glycemic control. * Body weight keeps constant. * Females of childbearing potential and males who are sexually active agree to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose. Exclusion Criteria: * Has participated in another clinical study within the past 90 days or has received any investigational compound within 30 days prior to randomization. * Has a systolic blood pressure beyond the acceptable range at Screening visit. * Has New York Heart Association Class III or IV heart failure regardless of therapy. * Has any major illness or debility that in the investigator's opinion prohibits the subject from completing the study. * Has a history of hypersensitivity or allergies to any DPP-4 inhibitor.

Locations (21)

Unnamed facility

Beijing, Beijing Municipality, China

Unnamed facility

Fuzhou, Fujian, China

Unnamed facility

Xiamen, Fujian, China

Outcomes

Primary Outcomes

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.

Time frame: Baseline and Week 16.

Secondary Outcomes

Change From Baseline in HbA1c Over Time

The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Weeks 4, 8 and 12. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.

Time frame: Baseline and Weeks 4, 8 and 12.

Change From Baseline in Fasting Plasma Glucose Over Time

The change from Baseline in fasting plasma glucose (FPG) at Weeks 4, 8, 12 and 16. Least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline FPG as a covariate for the monotherapy, baseline FPG with baseline metformin dose as covariates for the metformin therapy, baseline FPG with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.

Time frame: Baseline and Weeks 4, 8, 12 and 16.

Percentage of Participants With Marked Hyperglycemia

Marked Hyperglycemia was defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.1 mmol/L).

Data from ClinicalTrials.gov

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