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Evaluating the True Magnitude of HYPOglycemic Events After THE Initiation of Sulfonylurea

Information source: Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: Observational (Other)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Institut de Recherches Cliniques de Montreal

Overall contact:
Rémi Rabasa-Lhoret, MD, PhD, Phone: 514-987-5666, Email: remi.rabasa-lhoret@ircm.qc.ca

Summary

Gliclazide formulations are known to be associated with a lower incidence of hypoglycaemia than glyburide, a characteristic that could impact the choice of second and third line therapy. However, little is known about the frequency of asymptomatic or unreported hypoglycemia and their impact on glycemic control and quality of life among patients using these sulfonylureas (SUs). Even with such agents, the frequency of hypoglycemia is probably underestimated since self-monitoring of blood glucose (SMBG) fail to identify asymptomatic episodes, especially among patients with higher risk of hypoglycemia unawareness (longer diabetes duration, elderly, recurrent hypoglycemia, etc.). No previous studies have reported total hypoglycemia as measured by continuous glucose monitoring system (CGMS) in a large group of Canadians, therefore underestimating the true incidence of these events. As with age hypoglycemia perception is reduced and consequences can be increased due to frailty, elderly could be especially sensitive to the risk of hypoglycemia. Documentation of the total number of hypoglycemia is a relevant objective to really appreciate the potential impact of gliclazide and gliclazide modified release (MR) in the Canadian context. The investigators propose a multicenter observational prospective study in order to study the incidence of hypoglycaemia measured by CGMS among patients with type 2 diabetes mellitus (T2DM) newly prescribed gliclazide or gliclazide MR. The investigators propose to perform a baseline testing (pre-initiation of the SU), at initiation (first week after the first dose of the SU) and after a 3 months follow-up of treatment with gliclazide or gliclazide MR, including medical history measures, quality of life and diabetes treatment satisfaction. In patients with T2DM already stabilized on metformin but not at goal (A1c >7. 0 mmol/L), and newly prescribed gliclazide or gliclazide MR, the objectives and hypotheses of the study are to estimate the incidence rate of hypoglycaemia as measured by continuous glucose monitoring system (CGMS) over a total of 3 weeks period following the initiation of the SU.

Clinical Details

Official title: Evaluating the True Magnitude of HYPOglycemic Events After THE Initiation of Sulfonylurea, by Continuous Glucose monItoring System: A Multicenter Study. The HYPOTHESIS Trial

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Total incidence rate of hypoglycemia episode

Total incidence rate of hypoglycemia episode

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 2 diabetes according to Canadian Diabetes Association definition

- Initiation of gliclazide or gliclazide MR at baseline

- Currently treated with stable metformin monotherapy (≥3 months)

- A1c: 7. 0% to 10. 0%

- Willing and able to comply with study procedures

Exclusion Criteria:

- Current or previous usage of any other type of antihyperglycemic medication except

metformin

- Use of medication known to interfere with glucose metabolism

- Insulin requiring patient: catabolic state and/or ketonuria

- Currently using CGMS or within the last 3 months

- Recent severe hypoglycemia (<3 months)

- Pregnancy or breast-feeding

- Limited life expectancy, high level of functional dependency, extensive coronary

disease at high risk of short term ischemic events or multiple major co-morbidities

Locations and Contacts

Rémi Rabasa-Lhoret, MD, PhD, Phone: 514-987-5666, Email: remi.rabasa-lhoret@ircm.qc.ca

Additional Information

Starting date: September 2015
Last updated: June 26, 2015

Page last updated: August 23, 2015

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