Diabetes Mellitus, Type 2Early Phase 1NCT05249881
"Efficacy of Once Weekly GLP 1 Analogue: Semaglutide. A Multicenter Experience From Pakistan."
A Early Phase 1 study testing Semaglutide Pen Injector in people with Diabetes Mellitus, Type 2 and Weight Change, Body, run by Aga Khan University at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Weight Change, Body
- What is being tested?
- Semaglutide Pen Injector
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesPakistan
- Study dates
- 10 Mar 2022to Dec 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female Type 2 Diabetic patients with age ≥18 years.
- Patients with HbA1c ≥ 7.5 % - ≤ 10.0%
- Patients with BMI ≥ 30
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Enrolling by invitation
Aga Khan University
Karachi, Sindh, 74800
- Recruiting
Rehman Medical Institute
Peshawar, KPK, 25100
Naseer Ahmed, PhD, 0333-3382013, dr.naseer99@gmail.com
About this study
Official title: "Efficacy of Once-weekly GLP 1 Analogue: Semaglutide. A Multicenter Experience From Pakistan."
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Weight Change, Body
- Being tested
- Semaglutide Pen Injector
- Medical subject headings
- Diabetes Mellitus, Type 2, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide Pen InjectorDrug
Also called Ozempic
All Diabetes mellitus type2 patients fulfilling the inclusion criteria, will receive 0.25mg Semaglutide injection per week and after two weeks dosage will be escalated to 0.5 mg/week for next 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| semaglutide | Other | semaglutide is an anti-diabetic medication used for the treatment of type 2 diabetes and long-term weight management. Semaglutide acts like human glucagon-like peptide-1 in that it increases insulin secretion, thereby increasing sugar metabolism Receives: Drug: Semaglutide Pen Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycemic Index in Diabetes mellitus type-2 Patients
Once weekly Semaglutide may result to remarkably change HbA1c level with in 3 months of use
Measured: 3 months
Secondary outcomes (1)
Weight Changes in Obese People
use of semaglutide may help obese people in controlling their weight gain.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start10 Mar 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Rehman Medical Institute - RMI
- Responsible party
- Principal investigator, NASEER AHMED, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249881
- Sponsor's protocol ID
- 07125
- Status last verified
- Aug 2022
- First submitted
- 9 Feb 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Efficacy of Once-weekly GLP 1 Analogue: Semaglutide. A Multicenter Experience From Pakistan."
- ClinicalTrials.gov ID
- NCT05249881
- Acronym / sponsor ID
- 07125
- Conditions
- Diabetes Mellitus, Type 2, Weight Change, Body
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Rehman Medical Institute - RMI
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| semaglutide | Other | Drug: Semaglutide Pen Injectorsemaglutide is an anti-diabetic medication used for the treatment of type 2 diabetes and long-term weight management. Semaglutide acts like human glucagon-like peptide-1 in that it increases insulin secretion, thereby increasing sugar metabolism |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both male and female Type 2 Diabetic patients with age ≥18 years.
- Patients with HbA1c ≥ 7.5 % - ≤ 10.0%
- Patients with BMI ≥ 30
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide Pen InjectorAlso: OzempicAll Diabetes mellitus type2 patients fulfilling the inclusion criteria, will receive 0.25mg Semaglutide injection per week and after two weeks dosage will be escalated to 0.5 mg/week for next 10 weeks. | Drug | semaglutide |
Primary outcome
Change in glycemic Index in Diabetes mellitus type-2 Patients
Time frame: 3 months
Once weekly Semaglutide may result to remarkably change HbA1c level with in 3 months of use
1 secondary outcome
Weight Changes in Obese People
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Semaglutide Pen Injector in people with Diabetes Mellitus, Type 2 and Weight Change, Body, run by Aga Khan University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Tahir Ghaffar, MBBS, FCPS (+92-3339284987, drtgktk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycemic Index in Diabetes mellitus type-2 Patients (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.