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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
Synexus Clinical Research SA (Pty) Ltd
Pretoria, Gauteng, South Africa
Parexel Bloemfontein
Bloemfontein, South Africa
Parexel George
George, South Africa
Parexel Port Elizabeth
Port Elizabeth, South Africa
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
HbA1c
HbA1c
Time frame: 12 weeks
Fasting plasma glucose
Fasting plasma glucose
Time frame: 12 weeks
Body weight
Body weight
Time frame: 12 weeks
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