Double blind, randomised, comparative, multicentre, parallel-group study design to evaluate the effects of Pioglitazone on cardiovascular risk markers in type 2 diabetes mellitus

In patients with type 2 diabetes the evaluation of Pioglitazone versus glibenclamide or metformin on markers of inflammation, platelets activation, thrombogenesis and oxidative stress

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000534381

Acronym

PRISCA

Enrollment

100

Registered

2008-10-21

Start date

2004-09-14

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Besides its critical role in metabolic homeostasis, PPAR-gamma modulates several cellular responses involved in atherothrombosis, thus exerting a possible effect on inflammatory response of endothelium, vessel smooth muscular cells and monocytes-macrophages. These observations suggest that pioglitazone might positively influence the progression of the atherosclerotic process in diabetes and can be regarded as a new therapeutical approach to reduce cardiovascular events.

Interventions

Pioglitazone via oral route 30-45 mg/day for a period of 16 weeks. At randomization Pioglitazone 30 mg/day will be given. At follow-up visits response to treatment will be assessed. Patient should be considered as non responder and it is suggested to be titrated to on higher dose (45 mg/day) when fasting blood glucose is >140mg/dL.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

35 Years to 75 Years

Healthy volunteers

Inclusion criteria

diagnosis of type 2 diabetes mellitus age >=35 and <=75 years subjects of either sex HbA1c levels <=9.0% treatment only by diet from at least 3 months female patients had to be postmenopausal, hysterectomised or surgically sterilized or using reliable and adequate contraceptive methods (oral contraception or Intra-uterine Devices [IUD]) female (childbearing potential) patients had to show a negative response to pregnancy test a co-operative attitude and ability to be trained to use correctly the investigational study drugs and to attain the study procedures written informed consent provided

Exclusion criteria

Type 1 diabetes mellitus; Treatment with other oral antidiabetics drugs or insulin in the 3 months preceding study entry; Pregnant or lactating females; Any disease with malabsorption; Acute or chronic pancreatitis; Familiar polyposis coli; Past medical history of myocardial infarction, transient ischemic attacks (TIAs) or stroke; Congestive heart failure (New York Heart Association [NYHA] I-IV class); Significant liver (Alanine aminoytransferase [ALT] > 2.5 upper limit of normal range) or renal (serum creatinine > 1.2 mg/dL) impairment; Anaemia of any aetiology (defined as haemoglobin levels < 10.5 g/dL) or any other clinically relevant haematological disease; Diagnosis or suspicion of any neoplastic disease; History of chronic alcohol or drug/substance abuse, or presence of other conditions potentially able to affect study subjects’ compliance; Concomitant therapy with statins, antioxidant drugs (e.g. vitamins, Q10 coenzyme, Superoxide dismutase [SOD]), beta-blockers, non steroidal antinflammatory drugs (NSAIDS), aspirin, corticosteroids; Known allergy, sensitivity or intolerance to study drugs and/or study drugs formulation ingredients; Participation in another trial in the 3 months preceding study entry

Outcome results