Double-blind comparative study of SYR-322-MET

Double-blind comparative study when metformin hydrochloride is added on to SYR-322.

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222327

Enrollment

374

Registered

2013-12-16

Start date

2013-12-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes mellitus

Interventions

investigational material(s) Generic name etc : SYR-322, metformin hydrochloride INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Inv

Eligibility

Sex/Gender

All

Inclusion 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. etc.

Exclusion criteria

Exclusion criteria: 1. The subject has any serious cardiac disease, any 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. etc.

Design outcomes

Primary

Measure	Time frame
HbA1c Primary timeframe Baseline and Week 24 Measurement of change from baseline in HbA1c	—

Secondary

Measure	Time frame
1. HbA1c, fasting blood glucose 2. Adverse events Secondary timeframe Baseline and Week 24 1. HbA1c and fasting blood glucose Measurement of HbA1c and fasting blood glucose 2. Adverse events Number of cases with adverse events	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026