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

NCT02485132 | Terminated

• 1 other identifier: HYPOTHESIS
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

Sulfonylurea are known to be associated with a risk of hypoglycaemia. However, little is known about the real frequency of asymptomatic or unreported hypoglycemia and their impact on glycemic control and quality of life among patients using sulfonylureas (SUs). 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 SUs 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 a SU. 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, including medical history measures, quality of life and diabetes treatment satisfaction. In patients with T2DM not at goal (A1c \>7.0 mmol/L), and newly prescribed a SU, 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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Sulfonylurea; Hypoglycemia; Quality of life

Outcome Measures

Primary Outcomes (2)

• Total incidence rate of hypoglycemia episode

  One week after initiation of the SU

• Total incidence rate of hypoglycemia episode

  One week at 3-month follow-up

Study Arms (1)

T2DM at SU initiation

T2DM newly prescribed a SU

Other: Observational

Interventions

Observational OTHER

Investigators propose to perform a one-week 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 a SU, including CGMS reading, medical history measures, quality of life and diabetes treatment satisfaction.

T2DM at SU initiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

T2DM not at goal (A1c \>7.0 mmol/L), and newly prescribed a SU

You may qualify if:

• Type 2 diabetes according to Canadian Diabetes Association definition
• Initiation of a SU at baseline
• A1c: 7.0% to 10.0%
• Willing and able to comply with study procedures

You may not qualify if:

• Current or previous usage (during the last 3 months) of insulin or repaglinide
• 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

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (2)

University of Toronto

Toronto, Ontario, M5C2T2, Canada

Location

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W1R7, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Rémi Rabasa-Lhoret, MD,PhD

  IRCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 21, 2015
• First Posted: June 30, 2015
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 27, 2017

Record last verified: 2017-06

Locations

CA (2)