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
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: PSN821
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa Study to Build an Understanding of the Pharmacokinetic-Pharmacodynamic Relationship of PSN821 in Type 2 Diabetes Patients (T2DM).

Resource links provided by NLM:


Further study details as provided by Prosidion Ltd.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 66
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Placebo Comparator: Placebo Drug: Placebo
Placebo twice a day for 12 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386099

Locations
South Africa
Synexus Clinical Research SA (Pty) Ltd
Pretoria, Gauteng, South Africa
Parexel Bloemfontein
Bloemfontein, South Africa, 9301
Parexel George
George, South Africa, 6529
Parexel Port Elizabeth
Port Elizabeth, South Africa, 6045
Sponsors and Collaborators
Prosidion Ltd.
  More Information

No publications provided

Responsible Party: Prosidion Ltd.
ClinicalTrials.gov Identifier: NCT01386099     History of Changes
Other Study ID Numbers: PSN821-202, MCC Trial Reference no
Study First Received: June 29, 2011
Last Updated: August 16, 2012
Health Authority: South Africa: National Health Research Ethics Council

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014