Back to resultsDulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin
Primary Purpose
Type 2 Diabetes Treated With Insulin, Obesity, Adolescent Obesity
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Dulaglutide
Liraglutide
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Treated With Insulin
Eligibility 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
Sites / Locations
- Zainab Khan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group DUL
Group LIR
Arm Description
Group taking Dulaglutide injections
Group taking Liraglutide injections
Outcomes
Primary Outcome Measures
Glycemic level
HbA1c
BMI
BMI measurements using weight and height measurements (anthropometric)
Adverse effects
Recording of adverse effects
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04829903
Brief Title
Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin
Official Title
Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin: Results From a Randomized Double Blinded Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
March 29, 2021 (Actual)
Study Completion Date
November 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Treated With Insulin, Obesity, Adolescent Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group DUL
Arm Type
Active Comparator
Arm Description
Group taking Dulaglutide injections
Arm Title
Group LIR
Arm Type
Placebo Comparator
Arm Description
Group taking Liraglutide injections
Intervention Type
Drug
Intervention Name(s)
Dulaglutide
Other Intervention Name(s)
Group DUL
Intervention Description
Dulaglutide injections
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Group LIR
Intervention Description
Liraglutide injections
Primary Outcome Measure Information:
Title
Glycemic level
Description
HbA1c
Time Frame
24 weeks for the duration of the study
Title
BMI
Description
BMI measurements using weight and height measurements (anthropometric)
Time Frame
24 weeks for the duration of the study
Title
Adverse effects
Description
Recording of adverse effects
Time Frame
24 weeks for the duration of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia Hussain, PhD
Organizational Affiliation
Al Ain University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zainab Khan
City
Lahore
State/Province
Punjab
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin
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