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Life sciences · Interventional Study
ClinicalTrials.gov · September 14, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07728318). This is a study registration, not published results. Lead sponsor: Akhtar Saeed Medical and Dental College. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 52 participants (ESTIMATED). Conditions: Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight. Interventions: OTHER: Tirzepatide + Standard Therapy (Intervention Group); OTHER: Standard Oral Antidiabetic Drugs (OADs). Primary outcome measures: Change in Glycemic Control (HbA1c) , Baseline, 3 months, and 6 months; Change in Body Weight , Baseline and monthly up to 6 months. Brief summary: Type 2 Diabetes Mellitus (T2DM) is a progressive metabolic disease, often compounded by obesity, that leads to serious long-term health complications. While traditional antidiabetic medications help manage blood sugar, many patients continue to struggle with uncontrolled diabetes and excess weight. Newer therapies, such as dual GIP/GLP-1 receptor agonists like Tirzepatide, have demonstrated significant efficacy in lowering blood glucose (HbA1c) and body weight in global clinical trials. However, real-world data regarding its efficacy, safety, and patient-reported satisfaction in South Asian populations, particularly in Pakistan, remains limited. This 6-month, quasi-experimental interventional study aims to compare the clinical outcomes and patient-reported satisfaction of once-weekly subcutaneous Tirzepatide (combined with standard oral antidiabetic therapy) versus standard therapy alone in obese patients with Type 2 Diabetes. A total of 52 eligible participants will be randomly allocated into two groups. Group 1 will receive standard oral antidiabetic treatment, while Group 2 will receive once-weekly Tirzepatide with dose escalation (starting at 2.5 mg monthly, increasing to 5 mg, and maintaining at 7.5 mg) alongside standard treatment. Primary evaluations will measure changes in HbA1c and body weight from baseline to 6 months. Secondary objectives include monitoring the frequency and severity of gastrointestinal side effects fortnightly and evaluating patient treatment satisfaction at 6 months using the validated Diabetes Treatment Satisfaction Questionnaire (DTSQ).