A Study to Evaluate Safety, Tolerability and P-Glucose After Multiple Ascending Oral Doses of AZD1656 in Type 2 Diabetes

A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in T2DM Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00747175

Acronym

MAD

Enrollment

Registered

2008-09-04

Start date

2008-08-31

Completion date

2009-04-30

Last updated

2010-12-03

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

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes

Brief summary

The purpose of this study is to assess safety and tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes

Interventions

DRUGAZD1656

Dose titration to 3 (alt 4) increasing dose-steps with oral suspension, 8 days treatment

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Male or surgically sterile female of non-childbearing potential (post-menopausal, ie natural or induced menopause with last menstruation \>1 year ago and LH and FSH in the post-menopausal range, and/or have undergone hysterectomy and/or bilateral oophorectomy * Diagnosed diabetes Mellitus patients treated with diet and exercise alone or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment * HbA1c ≤10.5 % at screening (HbA1c value according to international DCCT standard)

Exclusion criteria

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP * History ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease * Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results. Positive test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus

Design outcomes

Primary

Measure	Time frame
Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG)	Blood samples taken repeatedly during 24 hours on study day sessions

Secondary

Measure	Time frame
Pharmacokinetic variables	Blood samples taken repeatedly during 24 hours on study day sessions
Pharmacodynamic variables	Blood samples taken repeatedly during 24 hours on study day sessions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026