Safety and Tolerability of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients Treated With Metformin and Sulfonylurea
NCT00995787 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2010-02-26
Summary
The primary aim of this study is to evaluate the safety and tolerability of AZD1656 in T2DM patients treated with metformin and sulfonylurea.
Conditions
- Type II Diabetes Mellitus
Interventions
- DRUG
-
AZD1656
Dose titration of oral suspension of AZD165 during 3 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 6 days
- DRUG
-
Dose titration of oral suspension of placebo during 3 days given twice daily. Subjects will thereafter be for another 6 days
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Klas Malmberg, MD, PhD · AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden
-
Marcus Dr. Marcus Hompesch, Dr · Profil Institute for Clinical Research Inc.855 3rd Avenue, Suite 4400Chula VistaCA 91911, USA
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 30 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-10-31
- Primary Completion
- 2010-02-28
- Completion
- 2010-02-28
Countries
- United States
Study Locations
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