Clinical trial NCT01431807: Long-term Study of SYR-472
Official title: An Open-label, Multicenter, Long-term Phase 3 Study to Evaluate the Safety and Efficacy of Long-term Treatment With SYR-472 in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Diet and/or Exercise Therapies or Treatment With an Existing Oral Anti-diabetic Drug Added to Diet and/or Exercise Therapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-09-12
Enrollment: 680
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic patients.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Adverse events
timeFrame: 52 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Akita-shi
country: Japan
state: Akita
city: Kisarazu-shi
country: Japan
state: Chiba
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Munakata-shi
country: Japan
state: Fukuoka
city: Koriyama-shi
country: Japan
state: Fukushima
city: Gihu-shi
country: Japan
state: Gihu
city: Fukuyama-shi
country: Japan
state: Hiroshima
city: Hiroshima-shi
country: Japan
state: Hiroshima
city: Eniwa-shi
country: Japan
state: Hokkaido
city: Ishikari-shi
country: Japan
state: Hokkaido
city: Nakagawa-gun
country: Japan
state: Hokkaido
city: Obihiro-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Kobe-shi
country: Japan
state: Hyogo
city: Mito-shi
country: Japan
state: Ibaragi
city: Naka-shi
country: Japan
state: Ibaragi
city: Takamatsu-shi
country: Japan
state: Kagawa
city: Sagamihara-shi
country: Japan
state: Kanagawa
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Tamana-shi
country: Japan
state: Kumamoto
city: Kyoto-shi
country: Japan
state: Kyoto
city: Nagano-shi
country: Japan
state: Nagano
city: Nagawaki-shi
country: Japan
state: Nagasaki
city: Oita-shi
country: Japan
state: Oita
city: Mino-shi
country: Japan
state: Osaka
city: Osaka-shi
country: Japan
state: Osaka
city: Sakai-shi
country: Japan
state: Osaka
city: Ageo-shi
country: Japan
state: Saitama
city: Kawaguchi-shi
country: Japan
state: Saitama
city: Koshigaya-shi
country: Japan
state: Saitama
city: Kuki-shi
country: Japan
state: Saitama
city: Saitama-shi
country: Japan
state: Saitama
city: Suntou-gun
country: Japan
state: Shizuoka
city: Oyama-shi
country: Japan
state: Tochigi
city: Chuo-ku
country: Japan
state: Tokyo
city: Koganei-shi
country: Japan
state: Tokyo
city: Meguro-ku
country: Japan
state: Tokyo
city: Shibuya-ku
country: Japan
state: Tokyo
city: Tama-shi
country: Japan
state: Tokyo
city: Tiyoda-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
name: Senior Director
role: STUDY_DIRECTOR
References: