NCT04829903

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2021

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

March 29, 2021

Last Update Submit

March 11, 2022

Conditions

Type 2 Diabetes Treated With InsulinObesityAdolescent Obesity

Outcome Measures

Primary Outcomes (3)

  • Glycemic level

    HbA1c

    24 weeks for the duration of the study

  • BMI

    BMI measurements using weight and height measurements (anthropometric)

    24 weeks for the duration of the study

  • Adverse effects

    Recording of adverse effects

    24 weeks for the duration of the study

Study Arms (2)

Group DUL

ACTIVE COMPARATOR

Group taking Dulaglutide injections

Drug: Dulaglutide

Group LIR

PLACEBO COMPARATOR

Group taking Liraglutide injections

Drug: Liraglutide

Interventions

DulaglutideDRUG

Dulaglutide injections

Also known as: Group DUL
Group DUL
LiraglutideDRUG

Liraglutide injections

Also known as: Group LIR
Group LIR

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zainab Khan

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

ObesityPediatric Obesity

Interventions

dulaglutideLiraglutide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Nadia Hussain, PhD

    Al Ain University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Resident

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 2, 2021

Study Start

January 2, 2020

Primary Completion

March 29, 2021

Study Completion

November 20, 2021

Last Updated

March 14, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)