Clinical trial

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

Opening soon · Not applicable · 0 countries · Registry ID NCT07728318

Opening soonNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 80 Years

SexAll

Healthy volunteersNot accepted

ConditionType 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Full registry 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.

Treatments and study arms

Tirzepatide + Standard Therapy (Intervention Group)

Other

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'

Standard Oral Antidiabetic Drugs (OADs)

Other

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 outcomes

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 WeightBaseline and monthly up to 6 months

Mean percentage change in body weight from baseline (a weight reduction of ≥5% is defined as clinically effective).

Study locations

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No public site location was included in this record. Check the original registry for updates.