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Trial · Interventional

CompletedPhase 4Registry data

Efficacy of Once Weekly Semaglutide in Patients With Type 2 Diabetes: a Non Randomized Clinical Trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
95 participants (actual)
Sponsor
Rehman Medical Institute - RMI · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Pakistan

Start
4 Jul 2022
Primary completion
30 Mar 2023
Completion
30 Mar 2023
First posted
28 Jul 2026
Last update posted
28 Jul 2026
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202220232024
  1. Ph 4

    Efficacy of Once Weekly Semaglutide in Patients With Type 2 Diabetes: a Non Randomized Clinical Trial

    NCT07732218

    4 Jul 2022 to 30 Mar 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

A single arm no randomized clinical trial evaluated the effectiveness and safety of once weekly semaglutide in adults with type 2 diabetes militus and obesity whose glycemic control remained inadequate despite standard therapy. participants received semaglutide for 16 weeks, beginning with 0.25mg weekly for 4 weeks followed by 0.5 mg weekly for 12 weeks. the primary outcome was the change in glycated hemoglobin, while secondary outcomes included changes in body weight, body mass index, blood glucose, blood pressure, lipid profile and treatment related adverse effects.

Interventions

  • Semaglutide (Ozempic®)Drug

Arms1

  • Experimental

    Once-weekly Semaglutide

    participants received subcutaneous semaglutide 0.25mg once weekly for 4 weeks followed by 0.5mg once weekly for 12 weeks, for a total treatment duration of 16 weeks

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in Glycated hemoglobin

    Time frame · baseline and 16 week

    Registry description

    Absolute change in hemoglobin from baseline to end of 16 weeks once weekly semaglutide treatment

  2. Changes in Glycated Hemoglobin

    Time frame · Baseline and week 16

    Registry description

    Absolute change in HBA1c from baseline to the end of 16 weeks of once weekly semaglutide treatment.

Secondary outcomes(4)
  1. Changes in body weight

    Time frame · baseline to week 16

    Registry description

    Changes in body weight, measured in kgs, from baseline to week 16

  2. Changes in BMI

    Time frame · rom baseline to week 16

    Registry description

    Changes in BMI, MEASURED IN KGS PER SQUARE METER, from baseline to week 16

  3. Changes in fasting Blood Glucose

    Time frame · baseline to week 16

    Registry description

    Changes in Fasting blood glucose from baseline to week 16

  4. Change in random blood glucose

    Time frame · Baseline to week 16

    Registry description

    Change in random blood glucose from baseline to week 16

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Adults aged 18 years or older. Established diagnosis of type 2 diabetes mellitus for at least 6 months. Glycated hemoglobin (HbA1c) between 7.5% and 10.0%. Body mass index (BMI) of at least 30 kg/m². Inadequate glycemic control despite ongoing standard diabetes therapy. Willing and able to provide written informed consent. Exclusion Criteria: Type 1 diabetes mellitus. Gestational diabetes mellitus. Severe renal impairment, defined as an estimated glomerular filtration rate of 30 mL/min/1.73 m² or less. Previous or current treatment with any glucagon-like peptide-1 receptor agonist. History of chronic pancreatitis. History of pancreatic malignancy. Diabetic retinopathy requiring active treatment. Other significant ocular complications. Pregnancy or lactation. Known thyroid disorders. History or presence of thyroid neoplasms.

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