| Trial ID: | L6819 |
| Source ID: | NCT01221545
|
| Associated Drug: |
Azd1656
|
| Title: |
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: AZD1656|DRUG: Placebo
|
| Outcome Measures: |
Primary: Primary Objective to assess the safety and tolerability of AZD1656, following oral administration of single ascending supratherapeutic doses of AZD1656 to patients with type 2 diabetes mellitus in a fasted state., From screening until Follow up | Secondary: Secondary objective to evaluate the pharmacokinetics (AUC, Cmax, t1/2, CL/F) of AZD1656 and its metabolite following oral administration of single ascending supratherapeutic doses of AZD1656, From pre-dose Day 1 to 48 hours after dose|Secondary objective to evaluate glucose levels and insulin secretion in type 2 diabetes mellitus patients following oral administration of single ascending supratherapeutic doses of AZD1656, Glucose levels from Day -1 to day 3|Secondary objective to evaluate glucose levels and insulin secretion in type 2 diabetes mellitus patients following oral administration of single ascending supratherapeutic doses of AZD1656, Insuline secretion from Day -1 to 2.
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2010-10
|
| Completion Date: |
2011-01
|
| Results First Posted: |
|
| Last Update Posted: |
2011-02-17
|
| Locations: |
Research Site, Chula Vista, California, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01221545
|
