Clinical trial NCT01289119: Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes
Official title: An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Determine the Efficacy and Safety of SYR-322 When Used in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes Mellitus
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-02-03
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline and Week 16.
Secondary outcomes:
measure: Change From Baseline in HbA1c Over Time
timeFrame: Baseline and Weeks 4, 8 and 12.
measure: Change From Baseline in Fasting Plasma Glucose Over Time
timeFrame: Baseline and Weeks 4, 8, 12 and 16.
measure: Percentage of Participants With Marked Hyperglycemia
timeFrame: Randomization to Week 16.
measure: Change From Baseline in Body Weight
timeFrame: Baseline and Weeks 8 and 16.
measure: Percentage of Participants With HbA1c ≤6.5% at Week 16
timeFrame: Week 16
measure: Percentage of Participants With HbA1c ≤7.0% at Week 16
timeFrame: Week 16
measure: Percentage of Participants With HbA1c ≤7.5% at Week 16
timeFrame: Week 16
measure: Percentage of Participants With a Decrease in HbA1c ≥ 0.5%
timeFrame: Baseline and Week 16
measure: Percentage of Participants With a Decrease in HbA1c ≥1.0%
timeFrame: Baseline and Week 16
measure: Percentage of Participants With a Decrease in HbA1c ≥1.5%
timeFrame: Baseline and Week 16.
measure: Percentage of Participants With a Decrease in HbA1c ≥2.0%
timeFrame: Baseline and Week 16.
Other outcomes:
Locations:
city: Beijing
country: China
state: Beijing
city: Fuzhou
country: China
state: Fujian
city: Xiamen
country: China
state: Fujian
city: Guangzhou
country: China
state: Guangdong
city: Haikou
country: China
state: Hainan
city: Ha'erbin
country: China
state: Heilongjiang
city: Jingzhou
country: China
state: Hubei
city: Shiyan
country: China
state: Hubei
city: Changsha
country: China
state: Hunan
city: Wuxi
country: China
state: Jiangsu
city: Nanchang
country: China
state: Jiangxi
city: Changchun
country: China
state: Jilin
city: Shenyang
country: China
state: Liaoning
city: Jinan
country: China
state: Shandong
city: Shanghai
country: China
state: Shanghai
city: Xi'an
country: China
state: Shanxi
city: Tianjin
country: China
state: Tianjin
city: Kunming
country: China
state: Yunnan
city: Hangzhou
country: China
state: Zhejiang
city: Hong Kong
country: Hong Kong
city: Taipei County
country: Taiwan
Study officials:
affiliation: Takeda
name: Professor Study Chair
role: STUDY_CHAIR
References: