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CompletedNCT01386099Updated Aug 17, 2012

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

A Phase 2 interventional study of PSN821 and Placebo in Type 2 Diabetes Mellitus, sponsored by Prosidion Ltd.. Completed at 4 sites in South Africa. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-08-17.

Sponsored by Prosidion Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus

10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 66 is below the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

This is the only study on the registry with Prosidion Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    PSN821

    Drug: PSN821

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugPSN821

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

  • DrugPlacebo

    Placebo twice a day for 12 weeks.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

Secondary outcomes

  1. HbA1c

    HbA1c

    Time frame: 12 weeks

  2. Fasting plasma glucose

    Fasting plasma glucose

    Time frame: 12 weeks

  3. Body weight

    Body weight

    Time frame: 12 weeks

07

Study locations

4 sites
  • Synexus Clinical Research SA (Pty) Ltd
    Pretoria, Gauteng, South Africa
  • Parexel Bloemfontein
    Bloemfontein, 9301, South Africa
  • Parexel George
    George, 6529, South Africa
  • Parexel Port Elizabeth
    Port Elizabeth, 6045, South Africa
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01386099
Lead sponsor
Prosidion Ltd.
Responsible party
Sponsor
First posted
Jun 30, 2011
Start date
May 2011
Primary completion
Jan 2012
Completion
May 2012
Last update
Aug 17, 2012
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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