A PK-PD Study of PSN821 in Type 2 Diabetes Patients (T2DM)
NCT ID: NCT01386099
Last Updated: 2012-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2011-05-31
2012-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PSN821
PSN821
Three PSN821 dose groups: PSN821 75mg twice a day, 250mg twice a day and 625mg twice a day for 12 weeks.
Placebo
Placebo
Placebo twice a day for 12 weeks.
Interventions
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PSN821
Three PSN821 dose groups: PSN821 75mg twice a day, 250mg twice a day and 625mg twice a day for 12 weeks.
Placebo
Placebo twice a day for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* Marked diabetic complications.
* Illness or medication that impacts on the scientific integrity of the study.
18 Years
75 Years
ALL
No
Sponsors
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Prosidion Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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MCC Trial Reference no
Identifier Type: OTHER
Identifier Source: secondary_id
PSN821-202
Identifier Type: -
Identifier Source: org_study_id