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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes
Started Sep 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 6, 2008
CompletedFirst Posted
Study publicly available on registry
October 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedDecember 3, 2010
December 1, 2010
6 months
October 6, 2008
December 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety variables (AE, BP, pulse, weight, plasma glucose, laboratory variables and ECG)
Blood samples taken repeatedly during 24 hours on study day sessions
Secondary Outcomes (2)
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
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Chula Vista, California, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Klas Malmberg, MD, PhD
AstraZeneca R&D Mölndal
- PRINCIPAL INVESTIGATOR
Marcus Hompesch, MD
Profil Institut for Clinical Research Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 6, 2008
First Posted
October 7, 2008
Study Start
September 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
December 3, 2010
Record last verified: 2010-12