< Practice Enhancement Programs / T2DM
Clinical Trial Name:
Time to Do More (T2DM) Study: Quality Enhancement Research Initiative in patients with Type 2 diabetes mellitus

Status: CLOSED enrolment as of August 31, 2007

PROTOCOL #:  CHRC-QERI 021

Brief description:
Observational Study, Multi-Center, Open Label Observational Quality Enhancement Research Initiative (QERI) in the glycemic control management involving patients with type 2 diabetes (DM) conducted over a 12 month treatment period.  Approximately 6,000 T2DM patients with an elevated A1C level (>7%) will be enrolled.  The goal will be to achieve the recommended target of A1C 6-7% and providing that this treatment is both safe and well tolerated and in general, in the best interests of the patient within the 4 scheduled clinic visits.

Eligibility:   
patients must agree to participate and sign an informed consent will be treated with any OHA recommended therapy as per the Canadian Diabetes Association (CDA) guidelines.

Inclusion criteria:    
Must be legal age of consent in the province the patient is a resident

T2DM:  diagnosis defined as:   
1.  Treatment with lifestyle changes and/or OHA;
2.  Symptoms of diabetes (including fatigue, polyuria, polydipsia and unexplained weight loss) plus a random/casual; plasma glucose value >= 11.1 mmol/L OR Fasting plasma glucose (FPG) >= 7.0 mmol/L OR A 2 hour post 75g glucose; challenge plasma glucose  >= 11.1 mmol/L;
3.  A1C >7%;
4.  Signed Informed Consent

Exclusion criteria:

1. Type 1 Diabetes Mellitus
2. Patients on insulin
3. Patients with clinically significant (as determined by the Investigator) concomitant illnesses or significant liver, muscle or kidney abnormalities
will be excluded.
4. Patients not able to receive and tolerate prescribed OHA therapy as recommended by the CDA guidelines.
5. Contraindication to usage of any prescribed OHA drug as per respective product monograph (e.g. pregnancy)
6. Gestational diabetes                                                            

Sponsor(s):
Canadian Heart Research Centre (CHRC) and GlaxoSmithKline (GSK)