Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Linagliptin: Patients will be put on orally administered tablet linagliptin 5 mg/day in addition to their ongoing treatment, i.e., oral tablet metformin and oral tablet glimepiride, for
Sponsors
Dr. Harshad Venugopal Ramineni
Eligibility
Inclusion criteria
Inclusion criteria: 1. Case of type 2 diabetes mellitus (T2DM), and 2. On a stable dose of oral tablet metformin = 1000 mg/day and oral tablet glimepiride = 2 mg/day for at least 12 weeks, and 3. Inadequately controlled blood glucose as indicated by HbA1c: = 7.5% and = 11% in the past 2 weeks, and 4. Started on either oral tablet linagliptin 5 mg/day, or oral tablet vildagliptin 100 mg/day in the past 1 week, and 5. Giving written consent for participating in the study
Exclusion criteria
Exclusion criteria: 1. Participants currently receiving insulin therapy for the management of T2DM, or 2. Participants currently receiving any other sulfonylureas (other than glimepiride), thiazolidinediones, sodium-glucose cotransporter-2 (SGLT2) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, or alpha-glucosidase inhibitors for the management of T2DM, or 3. Participants currently receiving beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), calcium channel blockers, or statins for cardiovascular management, or 4. Participants currently receiving prokinetic agents, such as metoclopramide, domperidone, trimebutine, cisapride, itopride, prucalopride and mosapride, or antacids containing aluminium or magnesium hydroxide, or 5. Participants with known allergies or sensitivities to linagliptin, vildagliptin, metformin or glimepiride, or 6. Pregnant or lactating individuals, or 7. Participants with a history of intolerance or adverse reactions to linagliptin, vildagliptin, or other dipeptidyl peptidase-4 (DPP-4) inhibitors, or 8. Participants with uncontrolled hepatic impairment (as indicated by elevated liver enzymes, i.e., AST or ALT, beyond three times the upper limit of laboratory reference range) or severe renal impairment (as indicated by creatinine clearance < 45 mL/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in HbA1c levels in type 2 diabetes mellitus patients receiving either linagliptin or vildagliptin as an adjunct to metformin and glimepiride.Timepoint: 0, 4 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in fasting blood sugar (FBS) and post-prandial blood sugar (PPBS) levelsTimepoint: 0, 4 weeks and 12 weeks;changes in body weight and waist circumferenceTimepoint: 0, 4 weeks and 12 weeks;alterations in lipid profilesTimepoint: 0, 4 weeks and 12 weeks;presence of adverse effects in both treatment groupsTimepoint: 0, 4 weeks and 12 weeks, as well as self-reporting of adverse reactions by patients apart from these time points. | — |
Countries
India
Contacts
Public ContactDr Harshad Venugopal Ramineni
Karnataka Institute of Medical Sciences, Hubli
Outcome results
None listed