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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01386099
• Other study ID #: PSN821-202
• Secondary ID: MCC Trial Refere
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2011
• Last updated: August 16, 2012
• Start date: May 2011
• Est. completion date: May 2012

Study information

• Verified date: August 2012
• Source: Prosidion Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: National Health Research Ethics Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
South Africa	Parexel Bloemfontein	Bloemfontein
South Africa	Parexel George	George
South Africa	Parexel Port Elizabeth	Port Elizabeth
South Africa	Synexus Clinical Research SA (Pty) Ltd	Pretoria	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
Prosidion Ltd.

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	HbA1c	HbA1c	12 weeks	No
Secondary	Fasting plasma glucose	Fasting plasma glucose	12 weeks	No
Secondary	Body weight	Body weight	12 weeks	No