A PK-PD Study of PSN821 in Type 2 Diabetes Patients (T2DM)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Prosidion Ltd.

ClinicalTrials.gov Identifier:

NCT01386099

First received: June 29, 2011

Last updated: August 16, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 29, 2011
Last Updated Date	August 16, 2012
Start Date ^ICMJE	May 2011
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 29, 2011)	Beta-cell function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01386099 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 29, 2011)	HbA1c [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] HbA1c Fasting plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Fasting plasma glucose Body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Body weight
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A PK-PD Study of PSN821 in Type 2 Diabetes Patients (T2DM)
Official Title ^ICMJE	A Phase IIa Study to Build an Understanding of the Pharmacokinetic-Pharmacodynamic Relationship of PSN821 in Type 2 Diabetes Patients (T2DM).
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Type 2 Diabetes Mellitus
Intervention ^ICMJE	Drug: PSN821 Three PSN821 dose groups: PSN821 75mg twice a day, 250mg twice a day and 625mg twice a day for 12 weeks. Drug: Placebo Placebo twice a day for 12 weeks.
Study Arm (s)	Experimental: PSN821 Intervention: Drug: PSN821 Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	66
Completion Date	May 2012
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with Type 2 diabetes according to the American Diabetes Association criteria, diagnosed at least 12 months prior to screening. Male or female, between 18 and 75 years of age, inclusive. Body Mass Index of 25 - 45 kg/m2, inclusive. Diabetes managed on a stable regimen of diet, exercise and metformin monotherapy (without dosage adjustments within 4 weeks prior to screening). Haemoglobin A1c (HbA1c) of 7.5 10% at screening. Fasting plasma glucose (FPG) of between 7 - 13.3 mmol/L at screening and Day -1. Males who are, and whose partners are able to comply with contraceptive advice. Females of non child-bearing potential. Willing to sign the written Informed Consent Form (ICF) to participate in the study and to abide by the study restrictions. Exclusion Criteria: Patients with Type 1 diabetes or maturity onset diabetes of the young or secondary forms of diabetes, such as due to pancreatitis. Marked diabetic complications. Illness or medication that impacts on the scientific integrity of the study.
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	South Africa

Administrative Information
NCT Number ^ICMJE	NCT01386099
Other Study ID Numbers ^ICMJE	PSN821-202, MCC Trial Reference no
Has Data Monitoring Committee	Not Provided
Responsible Party	Prosidion Ltd.
Study Sponsor ^ICMJE	Prosidion Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Prosidion Ltd.
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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