Diabete Type 2
Conditions
Brief summary
Our trial goal is to determine the efficacy and safety of sitagliptin in comparison with empagliflozin in type 2 diabetic Egyptian patients.
Interventions
Adding on sitagliptin to uncontrolled T2D Egyptian patients who are not controlled with diet, exercise and metformin with or without other OADs for 12 weeks.
DRUGEmpagliflozin 12.5 MG
Adding on empagliflozin to uncontrolled T2D Egyptian patients who are not controlled with diet, exercise and metformin with or without other OADs for 12 weeks.
DRUGSitagliptin 50 mg + Empagliflozin 12.5 MG
Adding on another 12 weeks of therapy of empagliflozin to sitagliptin 50mg group not well controlled (HbA1c 7-10%)
DRUGEmpagliflozin 12.5 MG + Sitagliptin 50 mg
Adding on another 12 weeks of therapy of sitagliptin 50mg to empagliflozin group not well controlled (HbA1c 7-10%)
Sponsors
Beni-Suef University
Sadat City University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 male/female diabetic patients * Age 20-70 years * A1C less than 10.5%
Exclusion criteria
* Type 1 diabetes; HbA1c \> 10.5% * Pregnancy * Chronic liver disease * Elevated (more than twofold the upper limit of normal) ALT, AST and CPK. * High bilirubin * Albumin \< 3.5 g/dl * INR \>1-2 Diabetic ketoacidosis * Urinary tract infection (UTI) * Pancreatitis \< 6 months prior to enrolment * Renal impairment (creatinine clearance ≤50 ml/min) * Treatment with anti-obesity drugs or glucagon-like peptide-1 receptor agonists (GLP-1RAs) 3 months prior to enrolment * Non-compliance with follow-up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of cured patients in the sitagliptin group versus the proportion of cured patients in the empagliflozin group | After completion of the study (One year anticipated) | The primary efficacy endpoint will be evaluated as clinical cure after 12 weeks of addition of sitagliptin or empagliflozin to metformin and after 12 weeks after adding empaglifozin to sitagliptin group and vise versa. Clinical cure defined by A1C controlled (less than 7%), decrease in fasting and postprandial plasma glucose (mg/dl). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The decrease in the body weight in patients in sitagliptin group versus empagliflozin group | After completion of the study (One year anticipated) | The decreased in body weight (Kg) from the baseline measures after therapy. |
| The decrease in blood pressure in patients in sitagliptin group versus empagliflozin group | After completion of the study (One year anticipated) | decrease in blood pressure is defined as the decrease in SBP and/or DBP (mmHg) from the baseline measures after completing therapy |
| The change in lipid profile in patients in sitagliptin group versus empagliflozin group | After completion of the study (One year anticipated) | Change in lipid profile including decreasing in the following measures from the baseline measures after therapy is completed: low density lipoprotein (mg/dl), total cholesterol (mg/dl), triglyceride (mg/dl) and high density lipoprotein (mg/dl). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of adverse effects appeared in patients in sitagliptin group versus percentage of adverse effects appear in patients in the empagliflozin group. | After completion of the study (One year anticipated) | AEs (n%) included all events with an onset after the first dose of open label emoagliflozin or sitagliptin and up to 7 days after the last dose of study drug. AEs of special interest included hypoglycaemia, genitourinary infections, hypersensitivity reactions, diabetic ketoacidosis, acute pancreatitis, hypotension, and dehydration. Confirmed hypoglycemic AEs were defined as events with a plasma glucose concentration of ≤ 3.9 mmol/L. |
Countries
Egypt
Outcome results
None listed