Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin

March 11, 2022 updated by: Dr Zainab Khan, Corporacion Parc Tauli

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Zainab Khan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 Diabetes Mellitus
  • Obese
  • Taking metformin
  • Male or female

Exclusion Criteria:

  • Non obese
  • Not taking metformin
  • Taking other injectable diabetic medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group DUL
Group taking Dulaglutide injections
Drug: Dulaglutide
Dulaglutide injections
Other Names:
  • Group DUL
PLACEBO_COMPARATOR: Group LIR
Group taking Liraglutide injections
Drug: Liraglutide
Liraglutide injections
Other Names:
  • Group LIR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic level
Time Frame: 24 weeks for the duration of the study
HbA1c
24 weeks for the duration of the study
BMI
Time Frame: 24 weeks for the duration of the study
BMI measurements using weight and height measurements (anthropometric)
24 weeks for the duration of the study
Adverse effects
Time Frame: 24 weeks for the duration of the study
Recording of adverse effects
24 weeks for the duration of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Nadia Hussain, PhD, Al Ain University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2020

Primary Completion (ACTUAL)

March 29, 2021

Study Completion (ACTUAL)

November 20, 2021

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (ACTUAL)

April 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DULACAI37628

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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