Diabetes Mellitus Type 2 Clinical Trial
Official title:
An Observational Study on the Use of Glucophage XR® Therapy in the Management of Patients With Type 2 Diabetes
This is a non-interventional, prospective study where no visits or additional interventions to the daily practice of the physician will be performed. Glucophage XR® has recently been available in Thailand for the treatment of patients with type 2 diabetes. A prospective observational study will be valuable to provide information on the day-to-day experience of using Glucophage XR® in the management of this patient population. The data may provide an insight into the use of Glucophage XR® in routine clinical practice in Thailand.
Metformin (Glucophage) is the standard first line therapy for patients with type 2 diabetes
mellitus. The landmark UK Prospective Diabetes Study Group demonstrated significant
reduction in the risk of myocardial infarction and overall mortality in overweight patients
with type 2 diabetes treated with metformin and metformin was more effective in controlling
blood glucose compared with lifestyle only diet-based policy. The observed improvement of
blood glucose was not associated with weight gain or hypoglycaemia in contrast to treatment
with either a sulphonylurea or insulin.
It is well accepted that patients' compliance with therapy tends to decrease as the dosage
frequency increases and that regimens should be simplified as far as possible to support
good compliance with therapy. The use of an extended-release formulation of metformin
(Glucophage XR®) may support the simplification of treatment for patients by allowing a
once-daily administration of metformin.
Although patients taking metformin had significantly lower fasting and postprandial plasma
glucose and hemoglobin A1C concentrations, they also had a higher prevalence of
Gastrointestinal (GI) side effects. The most commonly reported symptoms was diarrhea (53,2 %
compared to 11,7% on placebo). In a study employing self-administered questionnaires to
ascertain GI symptoms in patients with type 2 diabetes approximately 20% of those taking
immediate-release metformin reported diarrhea as the most common symptoms. Although less
than 5% of patients discontinue metformin treatment for this reason, such adverse events can
be troublesome, may limit the dosage of metformin and may impair compliance with therapy.
Glucophage XR may lead to improved tolerability, by smoothing the peaks and troughs in
metformin plasma concentrations and delaying the achievement of peak plasma concentration,
compared with an immediate-release formulation. Initial placebo-controlled clinical trials
with Glucophage XR indicate that 9,6% patients reported diarrhea (compare to 1,5% on
placebo).
Thus, the use of Glucophage XR® may provide benefits in terms of improved patient
management, by enabling once-daily dosing and reducing the incidence of gastrointestinal
side effects for some patients. A prospective observational study will be valuable to
provide information on the day-to-day experience of using Glucophage XR® in the management
of this patient population. The data may provide an insight into the use of Glucophage XR®
in routine clinical practice in Thailand.
;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01267448 -
Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia
|
Phase 4 | |
Active, not recruiting |
NCT05330247 -
Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study
|
N/A | |
Terminated |
NCT02743598 -
Liraglutide for HIV-associated Neurocognitive Disorder
|
Phase 4 | |
Terminated |
NCT02373865 -
Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT01741181 -
Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2
|
Phase 4 | |
Completed |
NCT01305434 -
Mulberry Leaf Extract and Blood Glucose Control in Diabetics
|
Phase 1/Phase 2 | |
Completed |
NCT01330121 -
Bridging the Gap by Transitional Care
|
N/A | |
Recruiting |
NCT00992797 -
Diabetes Intervention Trial With Vitamin D in Subjects of Nordic and Sub-Indian Ethnicity
|
Phase 2 | |
Completed |
NCT01580904 -
Impact of Pharmaceutical Care in Diabetics Patients
|
N/A | |
Active, not recruiting |
NCT00728403 -
Metabolic and Therapeutic Effects of American and Korean Red Ginseng in the Treatment of Type 2 Diabetes
|
Phase 2 | |
Completed |
NCT00763815 -
GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone
|
Phase 3 | |
Active, not recruiting |
NCT00529815 -
Continuous Glucose Monitoring in Patients With Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT00517465 -
A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.
|
Phase 1 | |
Withdrawn |
NCT00417716 -
Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema
|
Phase 3 | |
Completed |
NCT00119041 -
Diabetes Telemedicine Consultation: A Systems Improvement Intervention
|
N/A | |
Withdrawn |
NCT00600236 -
HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population
|
Phase 3 | |
Active, not recruiting |
NCT05887635 -
Study of Duodenal Mucosal RF Vapor Ablation in Subjects With Type-2 Diabetes Mellitus
|
N/A | |
Completed |
NCT03903965 -
Comparison of Retinal Perfusion Between Diabetic and Non-diabetic Patients With OCT Angiography After Cataract Surgery.
|
||
Completed |
NCT02666924 -
Cooking Classes for Chinese Canadian Patients Living With Diabetes
|
N/A | |
Recruiting |
NCT02501850 -
The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a)
|
Phase 4 |