Type 2 Diabetes Mellitus Clinical Trial
Official title:
An Observational Study to Assess the Impact of Pharmacological Intervention and Life Style Changes in the Reduction of Cardiovascular Disease in Patients With Diabetes Type 2 in Greece
| NCT number | NCT00648284 |
| Other study ID # | 104243 |
| Secondary ID | Avandia OB |
| Status | Completed |
| Phase | N/A |
| First received | March 27, 2008 |
| Last updated | October 13, 2008 |
| Start date | March 2004 |
| Verified date | October 2008 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Greece: National Organization of Medicines |
| Study type | Observational |
The primary objective of this study is to assess the total CV risk in patients with type 2 diabetes and also to assess the impact of rosiglitazone in the total CV risk and the parameters of metabolic syndrome.
| Status | Completed |
| Enrollment | 1100 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 80 Years |
| Eligibility |
Inclusion criteria: - Patients with diabetes type 2 that their physician has decided to prescribe AVANDIA for better control of their condition - Have signed informed consent Exclusion Criteria: - Patients with ALT > 2.5x the normal value - With heart failure symptoms - With diagnosis of angina pectoris or stable angina demanding continuous treatment with nitrates - With recent myocardial infarction (<6 months) - With severe renal disfunction - Pregnant or lactating or planned to be pregnant during the study - Under investigational drug treatment - Alcoholic or drug abuser |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
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