Double-blind Comparative Study of SYR-472

NCT01632007 | Completed Phase 3

• 3 other identifiers: SYR-472/CCT-002U1111-1128-6104JapicCTI-121839
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 22

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Glycosylated hemoglobin (HbA1c)

  Measurement of change in HbA1c (ratio of hemoglobin bound to glucose).

  24 weeks.

Study Arms (3)

SYR-472 100 mg

EXPERIMENTAL

Drug: SYR-472

Alogliptin 25 mg

ACTIVE COMPARATOR

Drug: Alogliptin 25 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SYR-472 DRUG

SYR-472 100 mg

Alogliptin 25 mg DRUG

Also known as: SYR-322

Alogliptin 25 mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.（e.g., subjects who require hospitalization or subjects who were hospitalized within 24 weeks prior to the commencement of the observation period)
• The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.

Sponsors & Collaborators

• Takeda: lead

Study Sites (22)

Unknown Facility

Akita, Akita, Japan

Location

Unknown Facility

Matsudo-shi, Chiba, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Fukuyama-shi, Hiroshima, Japan

Location

Unknown Facility

Ishikari-shi, Hokkaido, Japan

Location

Unknown Facility

Nakagawa-gun, Hokkaido, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Naka, Ibaragi, Japan

Location

Unknown Facility

Sagamihara-shi, Kanagawa, Japan

Location

Unknown Facility

Kumamoto, Kumamoto, Japan

Location

Unknown Facility

Kashiwara-shi, Osaka, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Suita-shi, Osaka, Japan

Location

Unknown Facility

Arakawa-ku, Tokyo, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, Japan

Location

Unknown Facility

Chiyoda-ku, Tokyo, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, Japan

Location

Unknown Facility

Itabashi-ku, Tokyo, Japan

Location

Unknown Facility

Katsushika-ku, Tokyo, Japan

Location

Unknown Facility

Mitaka-shi, Tokyo, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, Japan

Location

Unknown Facility

Shunan-shi, Yamaguchi, Japan

Location

Related Publications (1)

• Inagaki N, Onouchi H, Maezawa H, Kuroda S, Kaku K. Once-weekly trelagliptin versus daily alogliptin in Japanese patients with type 2 diabetes: a randomised, double-blind, phase 3, non-inferiority study. Lancet Diabetes Endocrinol. 2015 Mar;3(3):191-7. doi: 10.1016/S2213-8587(14)70251-7. Epub 2015 Jan 19.

  PMID: 25609193 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

trelagliptin; alogliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Medical Director

  Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2012
• First Posted: June 29, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

JP (22)