Long-term Study of SYR-472

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01431807
• Collaborator: (none)
• Enrollment: 680
• Locations: 41
• Arm: 1
• Duration (Months): 21
• Patients Per Site: 16.6
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: SYR-472	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 680 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2011
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SYR-472 group (long-term monotherapy or long-term combination therapy with anti-diabetic drugs)	Drug: SYR-472; oral, for up to 52 weeks.

Outcome Measures

Primary Outcome Measures

1. Adverse events [52 weeks.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Akita-shi	Akita	Japan
2		Kisarazu-shi	Chiba	Japan
3		Fukuoka-shi	Fukuoka	Japan
4		Munakata-shi	Fukuoka	Japan
5		Koriyama-shi	Fukushima	Japan
6		Gihu-shi	Gihu	Japan
7		Fukuyama-shi	Hiroshima	Japan
8		Hiroshima-shi	Hiroshima	Japan
9		Eniwa-shi	Hokkaido	Japan
10		Ishikari-shi	Hokkaido	Japan
11		Nakagawa-gun	Hokkaido	Japan
12		Obihiro-shi	Hokkaido	Japan
13		Sapporo-shi	Hokkaido	Japan
14		Kobe-shi	Hyogo	Japan
15		Mito-shi	Ibaragi	Japan
16		Naka-shi	Ibaragi	Japan
17		Takamatsu-shi	Kagawa	Japan
18		Sagamihara-shi	Kanagawa	Japan
19		Yokohama-shi	Kanagawa	Japan
20		Kumamoto-shi	Kumamoto	Japan
21		Tamana-shi	Kumamoto	Japan
22		Kyoto-shi	Kyoto	Japan
23		Nagano-shi	Nagano	Japan
24		Nagawaki-shi	Nagasaki	Japan
25		Oita-shi	Oita	Japan
26		Mino-shi	Osaka	Japan
27		Osaka-shi	Osaka	Japan
28		Sakai-shi	Osaka	Japan
29		Ageo-shi	Saitama	Japan
30		Kawaguchi-shi	Saitama	Japan
31		Koshigaya-shi	Saitama	Japan
32		Kuki-shi	Saitama	Japan
33		Saitama-shi	Saitama	Japan
34		Suntou-gun	Shizuoka	Japan
35		Oyama-shi	Tochigi	Japan
36		Chuo-ku	Tokyo	Japan
37		Koganei-shi	Tokyo	Japan
38		Meguro-ku	Tokyo	Japan
39		Shibuya-ku	Tokyo	Japan
40		Tama-shi	Tokyo	Japan
41		Tiyoda-ku	Tokyo	Japan

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Senior Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT01431807
• Other Study ID Numbers: SYR-472/OCT-001; JapicCTI-111592; U1111-1123-6415
• First Posted: Sep 12, 2011
• Last Update Posted: Jun 14, 2016
• Last Verified: Jun 1, 2016

• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

No Results Posted as of Jun 14, 2016