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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: PSN821; Drug: Placebo

• Registration Number: NCT01386099
• Lead Sponsor: Prosidion Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-06-30
• Primary Completion: 2012-01
• Study Completion: 2012-05
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-16
• Last Update Posted: 2012-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PSN821	PSN821	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Beta-cell function	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 Outcome Measures

Name	Time	Method
HbA1c	12 weeks	HbA1c
Fasting plasma glucose	12 weeks	Fasting plasma glucose
Body weight	12 weeks	Body weight

Trial Locations

Locations (4)

Parexel George; 🇿🇦 George, South Africa

Parexel Bloemfontein; 🇿🇦 Bloemfontein, South Africa

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

Parexel Port Elizabeth; 🇿🇦 Port Elizabeth, South Africa