Type 2 Diabetes Clinical Trial
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
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05219994 -
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
|
N/A | |
| Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
| Completed |
NCT02284893 -
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
|
Phase 3 | |
| Completed |
NCT04274660 -
Evaluation of Diabetes and WELLbeing Programme
|
N/A | |
| Active, not recruiting |
NCT05887817 -
Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
|
Phase 4 | |
| Active, not recruiting |
NCT05566847 -
Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
|
N/A | |
| Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
| Completed |
NCT04965506 -
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
|
Phase 2 | |
| Recruiting |
NCT06115265 -
Ketogenic Diet and Diabetes Demonstration Project
|
N/A | |
| Active, not recruiting |
NCT03982381 -
SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes
|
Phase 4 | |
| Completed |
NCT04971317 -
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
|
N/A | |
| Completed |
NCT04496154 -
Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood
|
N/A | |
| Completed |
NCT04023539 -
Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes
|
N/A | |
| Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
| Enrolling by invitation |
NCT05530356 -
Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
|
||
| Completed |
NCT04097600 -
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets
|
Phase 1 | |
| Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
| Completed |
NCT05378282 -
Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
|
||
| Recruiting |
NCT06010004 -
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
|
Phase 3 | |
| Completed |
NCT03653091 -
Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes
|
N/A |