Type II Diabetes Mellitus Clinical Trial
Official title:
Real World Assessment of Clinical Outcome Changes -Including Month of Ramadan- for Dapagliflozin in Management of Type 2 Diabetes Mellitus
REWARD is an Non Interventional study aims to describe the changes in the clinical outcomes of Type 2 Diabetes Mellitus patients who are treated with Dapagliflozin for a period of one year including the fasting period of Ramadan
REWARD is a multi-center, post-authorization, prospective, open label, non-interventional,
real-life, observational, cohort study. The study is to be conducted at 10-15 sites .
Aims to describe the changes in the clinical outcomes over 1 year as follows:
1. Primary Objective:
To describe the change in HbAlc from baseline as a parameter for blood glucose control.
2. Secondary Objective:
To describe the changes from baseline in the following parameters:
- Total body weight.
- Total cholesterol, LDL-C, non-HDL-C and triglycerides.
- Systolic and Diastolic Blood Pressures.
3. Other Objective:
To capture the frequency & incidence of the following reported adverse events :
- Hypoglycemic episodes.
- Volume Depletion.
- Genital infections.
- Urinary tract infections.
4. Exploratory Objective:
To describe the combined effect of the hot climate season and fasting Ramadan on the level of
total ketone bodies levels in T2DM subjects treated with Dapagliflozin.Description of outcome
variables in relation to objectives and hypotheses
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01952535 -
A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral HMS5552 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT01196728 -
Single-centre, Randomised, Double-blind, Placebo-controlled, Four-way Crossover Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Doses of CM3.1-AC100 in Patients With Type 2 Diabetes
|
Phase 1 | |
| Terminated |
NCT00997152 -
Efficacy and Safety Study of JTT-654 in Type 2 Diabetic Patients
|
Phase 2 | |
| Completed |
NCT02592421 -
SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2
|
Phase 3 | |
| Completed |
NCT05544214 -
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD 371 in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01969084 -
The Effect of Linagliptin on Mitochondrial and Endothelial Function
|
Phase 4 | |
| Terminated |
NCT01644201 -
A Study Evaluating the Effects of a High Viscosity Non-starch Polysaccharide (PolyGlycopleX® - PGX®) on Glycemic Control, Cardiometabolic Risk Factors and Weight Loss in Overweight and Obese Type II Diabetics
|
Phase 3 | |
| Completed |
NCT00995787 -
Safety and Tolerability of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients Treated With Metformin and Sulfonylurea
|
Phase 1 | |
| Completed |
NCT01020123 -
Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients
|
Phase 2 | |
| Completed |
NCT01505426 -
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients
|
Phase 3 | |
| Completed |
NCT01262586 -
Vildagliptin Glycemic Profiles Assessment Using a Continuous Glucose Monitoring Device.
|
Phase 3 | |
| Completed |
NCT00561171 -
Phase IIa Study to Investigate the Efficacy and Safety of SPP635 in Diabetic and Hypertensive Patients With Albuminuria
|
Phase 2 | |
| Active, not recruiting |
NCT03912363 -
Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids
|
N/A | |
| Completed |
NCT01868646 -
Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type II Diabetes Mellitus
|
Phase 4 | |
| Active, not recruiting |
NCT06386328 -
A Clinical Trial to Evaluate the Food Effect of CKD-378
|
Phase 1 | |
| Terminated |
NCT02749435 -
A Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With Type 2 Diabetes Mellitus
|
N/A | |
| Completed |
NCT00894868 -
Effect of Vildagliptin on Left Ventricular Function in Patients With Type 2 Diabetes and Congestive Heart Failure
|
Phase 4 | |
| Recruiting |
NCT01165190 -
Effect of Pioglitazone on Mitochondrial Function in Muscle and Adipose Tissue in Humans
|
N/A | |
| Completed |
NCT01255085 -
Yellow Pea Protein and Fibre and Short Term Food Intake
|
N/A | |
| Completed |
NCT02156349 -
A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients.
|
N/A |