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

A Phase IIa Study to Build an Understanding of the Pharmacokinetic-Pharmacodynamic Relationship of PSN821 in Type 2 Diabetes Patients (T2DM).

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: PSN821; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Africa
  • Bloemfontein, South Africa, 9301
    • PAREXEL Bloemfontein
  • George, South Africa, 6529
    • PAREXEL George
  • Port Elizabeth, South Africa, 6045
    • PAREXEL Port Elizabeth
  • Gauteng
    • Pretoria, Gauteng, South Africa
      • Synexus Clinical Research SA (Pty) Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo twice a day for 12 weeks.
Experimental: PSN821	Drug: PSN821; Three PSN821 dose groups: PSN821 75mg twice a day, 250mg twice a day and 625mg twice a day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1c	12 weeks
Fasting plasma glucose	Fasting plasma glucose	12 weeks
Body weight	Body weight	12 weeks

Collaborators and Investigators

• Sponsor: Prosidion Ltd.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: June 29, 2011
• First Submitted That Met QC Criteria: June 29, 2011
• First Posted (Estimate): June 30, 2011

Study Record Updates

• Last Update Posted (Estimate): August 17, 2012
• Last Update Submitted That Met QC Criteria: August 16, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PSN821-202; MCC Trial Reference no (Other Identifier: 20110147)