Type 2 Diabetes Treated With InsulinNCT04829903
Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin
A study testing Dulaglutide and Liraglutide in people with Type 2 Diabetes Treated With Insulin and Obesity, run by Corporacion Parc Tauli at 1 site in Pakistan.
Trial summary
To compare the efficacy and effect on glycemic control of Dulaglutide versus Liraglutide in obese Type 2 diabetic adolescents using metformin Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Type 2 Diabetes Treated With Insulin, Obesity, Adolescent Obesity
- What is being tested?
- Dulaglutide and Liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jan 2020to 20 Nov 2021
- Phase
- Interventional
- 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 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type 2 Diabetes Mellitus
- Obese
- Taking metformin
- Male or female
Who cannot join
- Non obese
- Not taking metformin
- Taking other injectable diabetic medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin: Results From a Randomized Double Blinded Clinical Trial
To compare the efficacy and effect on glycemic control of Dulaglutide versus Liraglutide in obese Type 2 diabetic adolescents using metformin
Read the detailed description
To observe the efficacy, effect on glycemic control, impact on BMI and incidence of adverse effects of Dulaglutide and to compare it to Liraglutide in individuals aged thirteen to eighteen who have Type 2 diabetes mellitus and are obese.
- Being tested
- Dulaglutide, Liraglutide
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DulaglutideDrug
Also called Group DUL
Dulaglutide injections
LiraglutideDrug
Also called Group LIR
Liraglutide injections
| Study group | Role | What they receive |
|---|---|---|
| Group DUL | Active comparator | Group taking Dulaglutide injections Receives: Drug: Dulaglutide |
| Group LIR | Placebo comparator | Group taking Liraglutide injections Receives: Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic level
HbA1c
Measured: 24 weeks for the duration of the study
BMI
BMI measurements using weight and height measurements (anthropometric)
Measured: 24 weeks for the duration of the study
Adverse effects
Recording of adverse effects
Measured: 24 weeks for the duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start2 Jan 2020
- Primary completion29 Mar 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Treated With InsulinStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Zainab Khan, Corporacion Parc Tauli
- Investigators
- Nadia Hussain, PhD, Principal investigator, Al Ain University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829903
- Sponsor's protocol ID
- DULACAI37628
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2021
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin: Results From a Randomized Double Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT04829903
- Acronym / sponsor ID
- DULACAI37628
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 2 Apr 2021 (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.
To compare the efficacy and effect on glycemic control of Dulaglutide versus Liraglutide in obese Type 2 diabetic adolescents using metformin
Detailed description
To observe the efficacy, effect on glycemic control, impact on BMI and incidence of adverse effects of Dulaglutide and to compare it to Liraglutide in individuals aged thirteen to eighteen who have Type 2 diabetes mellitus and are obese.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group DUL | Active comparator | Drug: DulaglutideGroup taking Dulaglutide injections |
| Group LIR | Placebo comparator | Drug: LiraglutideGroup taking Liraglutide injections |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Type 2 Diabetes Mellitus
- Obese
- Taking metformin
- Male or female
Key exclusion criteria (3 listed)
- Non obese
- Not taking metformin
- Taking other injectable diabetic medications
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 |
|---|---|---|
| DulaglutideAlso: Group DULDulaglutide injections | Drug | Group DUL |
| LiraglutideAlso: Group LIRLiraglutide injections | Drug | Group LIR |
Primary outcome
Glycemic level
Time frame: 24 weeks for the duration of the study
HbA1c
BMI
Time frame: 24 weeks for the duration of the study
BMI measurements using weight and height measurements (anthropometric)
Adverse effects
Time frame: 24 weeks for the duration of the study
Recording of adverse effects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 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.
Nadia Hussain, PhD principal investigator
Al Ain University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dulaglutide and Liraglutide in people with Type 2 Diabetes Treated With Insulin and Obesity, run by Corporacion Parc Tauli at 1 site 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic level (time frame: 24 weeks for the duration of the study). The study lists 3 primary outcomes in all. 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 14 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.