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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: PSN821
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSN821<br> | Drug: PSN821<br>* Three PSN821 dose groups: PSN821 75mg twice a day, 250mg twice a day and 625mg twice a day for 12 weeks.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo twice a day for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | HbA1c | 12 weeks | 
| Fasting plasma glucose | Fasting plasma glucose | 12 weeks | 
| Body weight | Body weight | 12 weeks |