Overview

Rosiglitazone Versus a Sulfonylurea On Progression Of Atherosclerosis In Patients With Heart Disease And Type 2 Diabetes

Status:
Completed
Trial end date:
2008-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to test the safety and effectiveness of rosiglitazone against a sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels of the heart.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Glipizide
Hypoglycemic Agents
Maleic acid
Rosiglitazone
Criteria
Inclusion criteria:

- Male or female between 30 to 80 years of age, inclusive.

- Established diagnosis of T2DM (based on diagnostic criteria of the American Diabetes
Association (ADA), WHO guidelines or local national guidelines).

- Subjects who are undergoing coronary angiography for evaluation of suspected or
previously diagnosed coronary artery disease or who are undergoing PCI.

- Subjects' prior anti-hyperglycemic diabetic therapy:

Diet and exercise only (drug naïve), with HbA1c >7.0 and £ 10.0%. HbA1c > 6.5 and <= 8.5%.

- Left ventricular ejection fraction (EF) ³ 40% as assessed by contrast ventriculography
(or previously documented in medical notes within one month prior to index procedure
by other methods e.g. echocardiography or nuclear study)

- Female subjects must be postmenopausal (i.e., >6 months without menstrual period),
surgically sterile, or using effective contraceptive measures (oral contraceptives,
Norplant, Depo-Provera, an intra-uterine device (IUD), a diaphragm with spermicide or
a condom with spermicide). Women of childbearing potential must use effective
contraceptive measures for at least 1 month prior to visit 1a, and should continue to
use the same contraceptive method during the study and for 30 days after discontinuing
study medication.

- Willingness and ability to give informed consent prior to entering the study and
available to complete the study.

Exclusion Criteria:

- Type 1 diabetes and/or history of diabetic ketoacidosis.

- Exposure to a TZD or other PPAR-g agonist within the 6 months prior to screening
visit.

- Subjects treated with triple OAD therapy or high dose dual combination OAD therapy
[1].

- Subjects who have required chronic insulin use in the last 6 months (except during
pregnancy or acute episodes such as hospitalization, trauma or infection).

- ST segment elevation myocardial infarction in the last 30 days.

- Subjects who have a history or are scheduled to receive coronary artery bypass graft
surgery (CABG), valve repair or replacement, aneurysmectomy or planned major
non-cardiac surgery during the study period.

- Subjects who have severe cardiac valvular disease

- Stroke or resuscitated in the past 6 months

- History of congestive heart failure (NYHA class I - IV)

- History of significant hypersensitivity or reaction (e.g., difficulty swallowing,
difficulty breathing, tachycardia or skin reaction) to any TZD, SU, biguanide or
insulin

- Prior history of severe edema or edema requiring medical treatment.

- Chronic disease requiring chronic or intermittent treatment with oral, intravenous, or
injected corticosteroids (use of topical, inhaled, or nasal corticosteroids is
permissible).

- Recent history or suspicion of current drug abuse or alcohol abuse within the last 6
months.

- Untreated hypo- or hyperthyroidism

- A diagnosis of cancer (other than superficial squamous, basal cell skin cancer, or
adequately treated cervical carcinoma in situ) in the past 3 years or current
treatment for the active cancer.

- Any clinically significant abnormality identified at the screening visit, physical
examination, laboratory tests, or electrocardiogram which, in the judgement of the
Investigator, would preclude safe completion of the study.

- Blood pressure: SBP >170 or DBP > 100 mmHg

- Significant anemia (Hemoglobin < 11 g/dL for males and < 10 g/dL for females).

- Significant renal disease manifested by serum creatinine (> 1.5mg/dL for males or >
1.4mg/dL for females), or where the use of metformin is contra-indicated.

- Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation
(ALT or AST > 2.5 times upper limit of normal (ULN) or bilirubin >2x ULN).

- History of myopathy or history of elevated creatine kinase (CK) > 3 times upper normal
limit.

- Use of an investigational drug within 30 days or 5 half-lives (whichever is the
longer).

- Women who are lactating, pregnant or planning to become pregnant during the course of
the study.

- Unwillingness or inability to comply with the procedures described in this protocol.