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Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04829903
Recruitment Status : Active, not recruiting
First Posted : April 2, 2021
Last Update Posted : April 2, 2021
Sponsor:
Information provided by (Responsible Party):
Dr Zainab Khan, Corporacion Parc Tauli

Study Description
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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
Type 2 Diabetes Treated With Insulin Obesity Adolescent Obesity Drug: Dulaglutide Drug: Liraglutide Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : January 2, 2020
Actual Primary Completion Date : March 29, 2021
Estimated Study Completion Date : November 20, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group DUL
Group taking Dulaglutide injections
 Drug: Dulaglutide
Dulaglutide injections
Other Name: Group DUL
Placebo Comparator: Group LIR
Group taking Liraglutide injections
 Drug: Liraglutide
Liraglutide injections
Other Name: Group LIR


Outcome Measures
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Primary Outcome Measures :
  1. Glycemic level [ Time Frame: 24 weeks for the duration of the study ]
    HbA1c

  2. BMI [ Time Frame: 24 weeks for the duration of the study ]
    BMI measurements using weight and height measurements (anthropometric)

  3. Adverse effects [ Time Frame: 24 weeks for the duration of the study ]
    Recording of adverse effects


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04829903


Locations
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Pakistan
Zainab Khan
Lahore, Punjab, Pakistan
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
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Principal Investigator: Nadia Hussain, PhD Al Ain University
More Information
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Responsible Party: Dr Zainab Khan, Chief Resident, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT04829903    
Other Study ID Numbers: DULACAI37628
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Liraglutide
 Dulaglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists