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

Prosidion

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: PSN821

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01386099

MCC Trial Reference no (Other Identifier)

PSN821-202

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.