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

NCT01386099 | Completed Phase 2

• 2 other identifiers: PSN821-202MCC Trial Reference no
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• HbA1c

  12 weeks

• Fasting plasma glucose

  12 weeks

• Body weight

  12 weeks

Study Arms (2)

PSN821

EXPERIMENTAL

Drug: PSN821

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PSN821 DRUG

Three PSN821 dose groups: PSN821 75mg twice a day, 250mg twice a day and 625mg twice a day for 12 weeks.

PSN821

Placebo DRUG

Placebo twice a day for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prosidion Ltd.: lead

Study Sites (4)

Synexus Clinical Research SA (Pty) Ltd

Pretoria, Gauteng, South Africa

Location

Parexel Bloemfontein

Bloemfontein, 9301, South Africa

Location

Parexel George

George, 6529, South Africa

Location

Parexel Port Elizabeth

Port Elizabeth, 6045, South Africa

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: June 30, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 17, 2012

Record last verified: 2012-08

Locations

ZA (4)