Clinical study of combinational therapy of AD-4833 with metformin -Phase III double-blind comparative study-

Clinical study of combinational therapy of AD-4833 with metformin -Phase III double-blind comparative study- - Clinical study of combinational therapy of AD-4833 with metformin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001110

Enrollment

160

Registered

2008-04-04

Start date

2005-04-01

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

Type2 Diabetes

Interventions

[Metformin] Metformin is orally administered at fixed doses throughout the baseline observation period and the treatment period. [AD-4833] In Period I, one AD-4833 15 mg tablet is orally administer

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Type 2 diabetes who are on medication with certain usage and dosage of Metformin (500mg or 750mg/day) during run-in period (2) Type 2 diabetes who practise certain diet therapy during run-in period (3) Type 2 diabetes whose HbA1C are over 6.5 % and under 10.0% after 8-week run-in period

Exclusion criteria

Exclusion criteria: (1)Type 1 diabetes (2)Those who have used different medication for diabetes from metformin-alone (including insulin) period,or have changed the diet therapy and exercise therapy during run-in period

Design outcomes

Primary

Measure	Time frame
Change in HbA1C at the end of the treatment period	—

Countries

Japan

Outcome results

None listed

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