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Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients

Not Yet RecruitingNA

Sponsor: Akhtar Saeed Medical and Dental College

Conditions: Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Interventions: Tirzepatide + Standard Therapy (Intervention Group), Standard Oral Antidiabetic Drugs (OADs)

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).

Eligibility overview

Sex: ALL

Age: 30 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Male and female patients aged 30 to 80 years with diagnosed Type 2 Diabetes Mellitus.
2. Uncontrolled diabetes with HbA1c ≥ 7.0%.
3. Obesity defined as Body Mass Index (BMI) ≥ 25 kg/m² (Asian population threshold) or waist circumference \> 90 cm in men or \> 80 cm in women.
4. History of taking oral antidiabetic drugs (OADs) for \> 1 year.

Exclusion Criteria:

1. Patients currently or previously taking GLP-1 receptor agonists or weight loss medications.
2. Patients currently receiving insulin therapy.
3. Patients taking DPP-4 inhibitors.
4. Pregnant or lactating females.