Clinical trial NCT01521962: Study of Combination Therapy With SYR-322
Official title: A Phase 3 Study to Investigate the Efficacy and Safety of SYR-322 When Used in Combination With Insulin Preparation in Subjects With Type 2 Diabetes in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-01-31
Enrollment: 67
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in patients with diabetes when used in combination with insulin.


Eligibility criteria: Inclusion Criteria:

1. The subject is an outpatient.
2. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

1. The subject has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
2. The subject is considered ineligible for the study for any other reason by the investigator or subinvestigator.

Primary outcomes:
measure: Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value)
timeFrame: Baseline and Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Aomori-shi
country: Japan
state: Aomori
city: Hirosaki-shi
country: Japan
state: Aomori
city: Kashiwa-shi
country: Japan
state: Chiba
city: Kisarazu-shi
country: Japan
state: Chiba
city: Kitakyushu-shi
country: Japan
state: Fukuoka
city: Aki-gun
country: Japan
state: Hiroshima
city: Fukuyama-shi
country: Japan
state: Hiroshima
city: Nishinomiya-shi
country: Japan
state: Hyogo
city: Koga-shi
country: Japan
state: Ibaraki
city: Ushiku-shi
country: Japan
state: Ibaraki
city: Kahoku-gun
country: Japan
state: Ishikawa
city: Hanamaki-shi
country: Japan
state: Iwate
city: Morioka-shi
country: Japan
state: Iwate
city: Kagoshima-shi
country: Japan
state: Kagoshima
city: Satsuma-sendai-shi
country: Japan
state: Kagoshima
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Minamata-shi
country: Japan
state: Kumamoto
city: Miyazaki-shi
country: Japan
state: Miyazaki
city: Nigata-shi
country: Japan
state: Nigata
city: Hirakata-shi
country: Japan
state: Osaka
city: Osaka-sayama-shi
country: Japan
state: Osaka
city: Osaka-shi
country: Japan
state: Osaka
city: Takatsuki-shi
country: Japan
state: Osaka
city: Yao-shi
country: Japan
state: Osaka
city: Kuki-shi
country: Japan
state: Saitama
city: Otsu-shi
country: Japan
state: Shiga
city: Hamamatsu-shi
country: Japan
state: Shizuoka
city: Shizuoka-shi
country: Japan
state: Shizuoka
city: Shimotsuke-shi
country: Japan
state: Tochigi
city: Shinagawa-ku
country: Japan
state: Tokyo
city: Toyama-shi
country: Japan
state: Toyama
city: Sagae-shi
country: Japan
state: Yamagata
city: Yamagata-shi
country: Japan
state: Yamagata
Study officials:
affiliation: Takeda
name: Senior Manager
role: STUDY_DIRECTOR
References:
citation: Kaku K, Mori M, Kanoo T, Katou M, Seino Y. Efficacy and safety of alogliptin added to insulin in Japanese patients with type 2 diabetes: a randomized, double-blind, 12-week, placebo-controlled trial followed by an open-label, long-term extension phase. Expert Opin Pharmacother. 2014 Oct;15(15):2121-30. doi: 10.1517/14656566.2014.956722. Epub 2014 Sep 5.