A PK-PD Study of PSN821 in Type 2 Diabetes Patients (T2DM) | NCT01386099

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

NCT01386099

Sponsor

Prosidion Ltd.

Status

Completed

Last Update Posted

Aug 17, 2012Estimated

Enrollment

66Actual

Phase

Phase 2

Conditions

Type 2 Diabetes Mellitus

Interventions

PSN821
Placebo

Countries

South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MCC Trial Reference no	Other Identifier	20110147

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Jan 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Jun 29, 2011

First Submission Date that Met QC Criteria

Jun 29, 2011

First Posted Date

Jun 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2012

Last Update Posted Date

Aug 17, 2012Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PSN821	Experimental		Drug: PSN821
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PSN821	Drug	Three PSN821 dose groups: PSN821 75mg twice a day, 250mg twice a day and 625mg twice a day for 12 weeks.	PSN821

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
HbA1c	HbA1c	12 weeks
Fasting plasma glucose	Fasting plasma glucose	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Synexus Clinical Research SA (Pty) Ltd		Pretoria	Gauteng		South Africa
Parexel Bloemfontein

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided