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

Phase 3

Completed

• Conditions: Type 2 diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12608000534381
• Lead Sponsor: Takeda Italia Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline of C-reactive protein assessed by blood analysis[The overall treatment period was of 16 weeks. The parameter will be evaluated at randomization and after 8 and 16 weeks after randomization.]