| Trial ID: | L5455 |
| Source ID: | NCT01386099
|
| Associated Drug: |
Psn821
|
| Title: |
A PK-PD Study of PSN821 in Type 2 Diabetes Patients (T2DM)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: PSN821|DRUG: Placebo
|
| Outcome Measures: |
Primary: Beta-cell function, Subjects will be assessed for beta-cell function using a hyperglycaemic clamp before the start of treatment and at the end of a 12 week treatment period as the primary endpoint., 12 weeks | Secondary: HbA1c, HbA1c, 12 weeks|Fasting plasma glucose, Fasting plasma glucose, 12 weeks|Body weight, Body weight, 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Prosidion Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
66
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-05
|
| Completion Date: |
2012-05
|
| Results First Posted: |
|
| Last Update Posted: |
2012-08-17
|
| Locations: |
Synexus Clinical Research SA (Pty) Ltd, Pretoria, Gauteng, South Africa|Parexel Bloemfontein, Bloemfontein, 9301, South Africa|Parexel George, George, 6529, South Africa|Parexel Port Elizabeth, Port Elizabeth, 6045, South Africa
|
| URL: |
https://clinicaltrials.gov/show/NCT01386099
|
