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Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin

Sponsor
Corporacion Parc Tauli (Other)
Overall Status
Completed
CT.gov ID
NCT04829903
Collaborator
(none)
116
Enrollment
1
Location
2
Arms
22.6
Actual Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the efficacy and effect on glycemic control of Dulaglutide versus Liraglutide in obese Type 2 diabetic adolescents using metformin

Condition or Disease Intervention/Treatment Phase
N/A

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

Study Type:
Interventional
Actual Enrollment :
116 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin: Results From a Randomized Double Blinded Clinical Trial
Actual Study Start Date :
Jan 2, 2020
Actual Primary Completion Date :
Mar 29, 2021
Actual Study Completion Date :
Nov 20, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Glycemic level [24 weeks for the duration of the study]

      HbA1c

    2. BMI [24 weeks for the duration of the study]

      BMI measurements using weight and height measurements (anthropometric)

    3. Adverse effects [24 weeks for the duration of the study]

      Recording of adverse effects

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 19 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Type 2 Diabetes Mellitus

    • Obese

    • Taking metformin

    • Male or female

    Exclusion Criteria:

    • Non obese

    • Not taking metformin

    • Taking other injectable diabetic medications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zainab Khan Lahore Punjab Pakistan

    Sponsors and Collaborators

    • Corporacion Parc Tauli

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Zainab Khan, Chief Resident, Corporacion Parc Tauli
    ClinicalTrials.gov Identifier:
    NCT04829903
    Other Study ID Numbers:
    • DULACAI37628
    First Posted:
    Apr 2, 2021
    Last Update Posted:
    Mar 14, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Obesity
    Pediatric Obesity
    Liraglutide
    Dulaglutide

    Study Results

    No Results Posted as of Mar 14, 2022