Clinical trial NCT05249881: "Efficacy of Once Weekly GLP 1 Analogue: Semaglutide. A Multicenter Experience From Pakistan."
Official title: "Efficacy of Once-weekly GLP 1 Analogue: Semaglutide. A Multicenter Experience From Pakistan."
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Diabetes Mellitus, Type 2
Weight Change, Body
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: Rehman Medical Institute - RMI
First posted: 2022-02-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A prospective interventional trial for 9 months will be carried out on 300 type-2 diabetes mellitus volunteer patients who are above 18-year-old and participants will be selected through consecutive sampling and will be evaluated on the basis of glycemic index and history of patients. Selected parameters will be measured at baseline and after the 12 weeks of therapy. Statistical analysis will be carried out by SPSS, ANOVA, and t-test.

From this experimental design, we are expecting improvement in the management of glycemic index, reduction in systolic and diastolic blood pressure, and reduction in weight GLP-1 naive patients.

Detailed description: Patients will be recruited from all the 12 centers included in the trial across Pakistan and data will be electronically transferred to the main center. All GLP-1 naive patients fulfilling the inclusion criteria will be recruited after informed written consent and started on Semaglutide injection 0.25mg for 2 weeks and will be escalated to 0.5 mg for the next 10 weeks. Socio-Demographic Data and health vitals including height, weight, BMI, baseline HbA1c, FBS and RBS will be recorded in preset Performa. All those who agree to participate will be given structured education on diet and exercise and those willing to comply will be recruited. A research assistant will be recruited and trained to teach the injection technique and discuss the adverse effects of Semaglutide to the participants. Patients taking DPP-4 inhibitors will be switched to GLP-1 analogue and only a single drug change in the form of adding Semaglutide will be done at the time. Semaglutide injection technique will be explained to the patient and one injection at a time will be provided to the patient to ensure compliance and avoid bias in the study. Patients will be asked to revisit after 4 weeks with the used injection device. After completion of 3 months of treatment vitals including height, weight, BMI, baseline HbA1c, FBS and RBS will be recorded in preset Performa.

Eligibility criteria: Inclusion Criteria:

* Both male and female Type 2 Diabetic patients with age ≥18 years.
* Patients with HbA1c ≥ 7.5 % - ≤ 10.0%
* Patients with BMI ≥ 30

Exclusion Criteria:

* Patients with Type 1 Diabetes Mellitus
* Patients with Gestational Diabetes Mellitus.
* Patients with Chronic Renal Failure with eGFR of ≤ 30ml/min
* Patient already on another GLP 1 analogue
* The patient stopped any GLP1 analogue treatment less than 3 months back.
* Patients with history of chronic pancreatitis or pancreatic cancer.

Primary outcomes:
measure: Change in glycemic Index in Diabetes mellitus type-2 Patients
timeFrame: 3 months
Secondary outcomes:
measure: Weight Changes in Obese People
timeFrame: 3 months
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Rehman Medical Institute
state: KPK
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
References: