To Evaluate Safety and Tolerability After Multiple Oral Doses of AZD1656 in Type 2 Diabetes Patients on Top of Metformin
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 Metformin
1 other identifier
interventional
70
2 countries
2
Brief Summary
The purpose of this study is to assess safety and tolerablility of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes on top of metformin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 type-2-diabetes
Started Oct 2008
Typical duration for phase_1 type-2-diabetes
2 active sites
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
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 16, 2008
CompletedFirst Posted
Study publicly available on registry
October 17, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedJanuary 15, 2010
January 1, 2010
October 16, 2008
January 14, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight 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
EXPERIMENTALAZD1656
2
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Male or female (with non child-bearing potential)
- Diagnosed diabetes Mellitus patients treated with metformin alone or one other anti-diabetic drugs. Stable blood sugar control indicated by no changed treatment within 3 months prior to study start.t
- HbA1c \<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 (2)
Research Site
San Antonio, Texas, United States
Research site
Ahmedabad, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Klas Malmberg, MD, PhD, Prof.,
AstraZeneca R&D Mölndal
- PRINCIPAL INVESTIGATOR
Dr Emanuel DeNoia, MD
Healthcare Discoveries LLC Icon Development Solutions
- PRINCIPAL INVESTIGATOR
Sanjay Sharma, MD
Veeda Clinical Research Pvt. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 16, 2008
First Posted
October 17, 2008
Study Start
October 1, 2008
Study Completion
January 1, 2010
Last Updated
January 15, 2010
Record last verified: 2010-01