A PK-PD Study of PSN821 in Type 2 Diabetes Patients (T2DM)
|ClinicalTrials.gov Identifier: NCT01386099|
Recruitment Status : Completed
First Posted : June 30, 2011
Last Update Posted : August 17, 2012
The purpose of this study is to investigate the pharmacokinetics and pharmacodynamics of PSN821 in patients with type 2 diabetes.
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. HbA1c, fasting plasma glucose and body weight are secondary endpoints.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: PSN821 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase IIa Study to Build an Understanding of the Pharmacokinetic-Pharmacodynamic Relationship of PSN821 in Type 2 Diabetes Patients (T2DM).|
|Study Start Date :||May 2011|
|Primary Completion Date :||January 2012|
|Study Completion Date :||May 2012|
Three PSN821 dose groups: PSN821 75mg twice a day, 250mg twice a day and 625mg twice a day for 12 weeks.
|Placebo Comparator: Placebo||
Placebo twice a day for 12 weeks.
- Beta-cell function [ Time Frame: 12 weeks ]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.
- HbA1c [ Time Frame: 12 weeks ]HbA1c
- Fasting plasma glucose [ Time Frame: 12 weeks ]Fasting plasma glucose
- Body weight [ Time Frame: 12 weeks ]Body weight
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386099
|Synexus Clinical Research SA (Pty) Ltd|
|Pretoria, Gauteng, South Africa|
|Bloemfontein, South Africa, 9301|
|George, South Africa, 6529|
|Parexel Port Elizabeth|
|Port Elizabeth, South Africa, 6045|