Condition: Type II Diabetes Mellitus · Efficacy, Self · Safety Issues · Sponsor: Getz Pharma
Study Objective To evaluate the safety and tolerability of Empagliflozin with or without metformin in patients with Type II Diabetes Mellitus in the Pakistani population. Study design Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study. Sample size The estimated sample size will be n=156. Duration of study 12 months (data lock point will be completion of 6 months' follow-up from the time of last patient's enrollment date) Safety Assessment: Patient will be monitored for Hypoglycemia, Dehydration, Hypotension, Urinary Tract Infections, Fungal Infections, Nausea, Vomiting, Diarrhea, Abdominal Discomfort, Flatulence, Asthenia, Indigestion and Other side effects (if any). Follow up visits: After recruitment, patient is supposed to have three visits for follow-ups. Visit 1: 4 to 6 weeks of initiation of therapy. Visit 02: At 12 weeks of initiation of therapy. Visit 03: At 24 weeks of initiation of therapy. LABORATORY TESTING: Reputable Lab is considered for laboratory testing of diabetes patients i.e. HbA1C%, FBG, RFT and urine R/E. The certified clinical lab will be responsible for receiving and analyzing clinical sample. Patients will have special discount of upto 50% for study related laboratory investigations. Where in Urine Routine Examination (Urine R/E), we consider as follows: * Visual Examination: * Urine color: Normal (Yellow), Pale Yellow, Dark Yellow, Brown, Red or Pink or any other. * Urine clarity: Clear, s…
This description comes directly from the study's public registry record.
Dr. Muhammad Nabeed Tahir · +923015376299 · nabeedt@gmail.com
Dr. Umar Wahab · +923339158285 · dromarwahab@yahoo.com
Always discuss trial participation with your own doctor first.
| Kabul University of Medical Sciences(KUMS) | Kabul, Afghanistan, Afghanistan | Completed |
| Agha Khan univeristy hospital | Nairobi, Kenya, Kenya | Recruiting |
| Lagos University Teaching Hospital | Lagos, Nigeria, Nigeria | Recruiting |
| Umar Diabetes Foundation | Islamabad, Pakistan | Completed |
| National hospital Sri Lanka | Colombo, Colombo, Sri Lanka | Completed |
| NHK | Kandy, Kandy, Sri Lanka | Completed |
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Source record: clinicaltrials.gov/study/NCT05164263