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A Randomized, Single-Blind, Placebo-Controlled, Multi-Centre, PhaseI Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Japanese T2DM Patients

A Randomized, Single-Blind, Placebo-Controlled, Multi-Centre, PhaseI Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Japanese T2DM Patients

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220768
Enrollment
Unknown
Registered
2009-07-07
Start date
2009-07-07
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

Interventions

investigational material(s) Generic name etc : AZD1656 INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : T

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - A body mass index (BMI) of 18 to 27 kg/m2. - Diagnosed Diabetes Mellitus patients treated with diet and exercise or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment.

Exclusion criteria

Exclusion criteria: - Renal dysfunction GFR 160mmHg or diastolic pressure (DBP) >95mmHg. - Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP. - History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.

Outcome results

None listed

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