Type 2 Diabetes Mellitus
Conditions
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.
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.
Sponsors
Prosidion Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 12 weeks | HbA1c |
| Fasting plasma glucose | 12 weeks | Fasting plasma glucose |
| Body weight | 12 weeks | Body weight |
Countries
South Africa
Outcome results
None listed