Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Conditions
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).
Interventions
OTHERTirzepatide + 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'
OTHERStandard 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
Sponsors
Akhtar Saeed Medical and Dental College
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycemic Control (HbA1c) | Baseline, 3 months, and 6 months | Mean change in HbA1c percentage from baseline to evaluate efficacy in glycemic control (a reduction of ≥1% is defined as clinically effective). |
| Change in Body Weight | Baseline and monthly up to 6 months | Mean percentage change in body weight from baseline (a weight reduction of ≥5% is defined as clinically effective). |
Outcome results
None listed