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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220880
Enrollment
Unknown
Registered
2009-09-28
Start date
2009-09-28
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 : Dapagliflozin (BMS-512148) INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investiga

Sponsors

AstraZeneca
Lead Sponsor
Bristol-Myers Squibb
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Japanese Subjects with type 2 diabetes mellitus. - Strictly/relatively treatment naive Subjects with HbA1c (7.0% to 10%), or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c (8% or less). - Provision of informed consent.

Exclusion criteria

Exclusion criteria: - Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease. - The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.

Outcome results

None listed

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