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).
Inclusion Criteria:
Exclusion Criteria:
Participants will continue their baseline standard oral antidiabetic drug (OAD) therapy (metformin with or without SGLT2 inhibitors like dapagliflozin or empagliflozin) for 6 months . All participants will also receive monthly dietary counseling from a nutritionist and a recommended walking regimen of 30 minutes, 5 days a week.
Participants will receive subcutaneous once-weekly Tirzepatide added to their baseline standard oral antidiabetic drug (OAD) therapy for 6 months . Tirzepatide will be initiated at 2.5 mg once weekly for Month 1, escalated to 5 mg once weekly for Month 2, and maintained at 7.5 mg once weekly for Months 3-6 . Participants will also receive monthly dietary counseling and a recommended walking regimen.
Efficacy and Safety of Tirzepatide for Weight Management
Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM)
Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity
Tirzepatide Use in People With Obesity and Type 1 Diabetes
A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo in Participants Who Are Either Obese or Overweight With Weight-Related Comorbidities (SURMOUNT-1)
Efficacy and Safety of GZR18 Every 2 Weeks Versus Tirzepatide and Placebo in Obese or Overweight Participants