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

Official title

Efficacy, Safety and Treatment Satisfaction of Once Weekly Tirzepatide in Obese Type 2 Diabetic Patients at a Tertiary Care Centre

Overview

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).

Interventions

• Other Tirzepatide + Standard Therapy (Intervention Group)
  Administered subcutaneously once weekly with dose escalation: Month 1: 2.5 mg once weekly Month 2: 5 mg once weekly Months 3 to 6: Maintenance dose of 7.5 mg once weekly'
• Other Standard Oral Antidiabetic Drugs (OADs)
  Standard oral antidiabetic therapy including Metformin (500mg, 1000mg, or 1500mg daily) with or without SGLT2 inhibitors (Dapagliflozin or Empagliflozin) maintained throughout the 6-month study period

Primary outcome measures

• Change in Glycemic Control (HbA1c) [Time frame: Baseline, 3 months, and 6 months]
• Change in Body Weight [Time frame: Baseline and monthly up to 6 months]

Eligibility criteria

Inclusion criteria

• Male and female patients aged 30 to 80 years with diagnosed Type 2 Diabetes Mellitus.
• Uncontrolled diabetes with HbA1c ≥ 7.0%.
• 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.
• History of taking oral antidiabetic drugs (OADs) for > 1 year.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07728318 · Exp141

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗