To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Insulin

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00768105

Enrollment

Registered

2008-10-07

Start date

2008-09-30

Completion date

2009-03-31

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 on top of insulin.

Interventions

DRUGAZD1656

Dose titration of oral suspension to a tolerable dose in 2-3 dose steps. Investigational product given twice daily for eight days.

DRUGPlacebo

Dosing to match AZD1656

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

* Female with non child-bearing potential * Diagnosed Diabetes Mellitus patients treated with insulin alone or insulin in combination with other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start. * HbA1c below or equal to 11 % 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 of ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease * Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.

Design outcomes

Primary

Measure	Time frame
Safety variables (AE, BP, pulse, weight, 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