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NCT Number: NCT01386099

A PK-PD Study 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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Synexus Clinical Research SA (Pty) Ltd, Pretoria, Gauteng, South Africa

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PSN821

Drug

Three PSN821 dose groups: PSN821 75mg twice a day, 250mg twice a day and 625mg twice a day for 12 weeks.

Placebo

Drug

Placebo twice a day for 12 weeks.

Primary outcomes

  1. 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.

Secondary outcomes

  1. HbA1c

    Time frame: 12 weeks

    HbA1c

  2. Fasting plasma glucose

    Time frame: 12 weeks

    Fasting plasma glucose

  3. Body weight

    Time frame: 12 weeks

    Body weight

Sponsors and collaborators

Lead sponsor

Prosidion Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 30, 2011
Registry last updated
Aug 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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