To Study Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1656 in Japanese Type 2 Diabetes Mellitus (T2DM) Patients
JMAD
A Randomized, Single-blind, Placebo-Controlled, Multi-centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Japanese T2DM Patients
1 other identifier
interventional
24
1 country
2
Brief Summary
The purpose of this study is to assess the safety and tolerability of AZD1656 after multiple repeated oral doses in Japanese patients with type 2 diabetes.
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 May 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 9, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedNovember 3, 2009
November 1, 2009
June 8, 2009
November 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety by assessment of adverse events, BP, pulse rate, plasma glucose, safety laboratory variables and ECG
Blood samples taken repeatedly during 24 hours on study day sessions
Secondary Outcomes (2)
Pharmacokinetic variables (AUC, Cmax, tmax, t½, CL/F, Ae and CLR).
Blood samples taken repeatedly during 24 hours on study day sessions
Pharmacodynamic variables (P-Glucose, S-Insulin and S-C-peptide).
Blood samples taken repeatedly during 24 hours on study day sessions
Study Arms (2)
A
EXPERIMENTAL3 gradually increasing repeated oral doses of AZD1656 given to 3 groups (6 on active substance in each group)
B
PLACEBO COMPARATORPlacebo oral suspension given to 3 groups (2 on placebo in each group)
Interventions
Eligibility Criteria
You may qualify if:
- Male or female non-childbearing potential Japanese T2DM patients, 30-75 years.
- A body mass index (BMI) of 19 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.
You may not qualify if:
- Renal dysfunction GFR \< 60 mL/min.
- Systolic pressure (SBP) \> 160 mmHg or diastolic pressure (DBP) \> 95 mmHg
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Research Site
Fukuoka, Japan
Research Site
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Klas Malmberg, MD
AstraZeneca R&D Mölndal
- PRINCIPAL INVESTIGATOR
Takashi Eto, MD, PhD
PS Clinic, Fukuoka, Japan
- PRINCIPAL INVESTIGATOR
Mitsuyasu Hokamura, MD
HONJO CLINIC II, Tokyo, Japan
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 8, 2009
First Posted
June 9, 2009
Study Start
May 1, 2009
Study Completion
October 1, 2009
Last Updated
November 3, 2009
Record last verified: 2009-11