Comparison of Exenatide and Metformin Monotherapy in Overweight/Obese Patients With Newly Diagnosed Type 2 Diabetes
Beijing Chao-Yang Hospital, Capital Medical University
1 other identifier
interventional
230
0 countries
N/A
Brief Summary
The present study assessed the therapeutic effect of exenatide and metformin as the initial therapy in overweight/obese patients with newly diagnosed Type 2 diabetes (T2D).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2013
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2016
CompletedFirst Submitted
Initial submission to the registry
September 26, 2017
CompletedFirst Posted
Study publicly available on registry
September 29, 2017
CompletedOctober 2, 2017
September 1, 2017
3.2 years
September 26, 2017
September 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The change of HbA1c
baseline and 12 weeks
Study Arms (2)
exenatide group
EXPERIMENTALThe drug-naïve, overweight or obese patients with newly diagnosed T2D
metformin group
ACTIVE COMPARATORThe drug-naïve, overweight or obese patients with newly diagnosed T2D
Interventions
Exenatide was administrated with 5 μg bid for 4 weeks and 10 μg bid for 8 weeks. Metformin hydrochloride was initiated at a dose of 500 mg bid for 2 weeks, and added to 2.0 g/day for 8 weeks.
Eligibility Criteria
You may qualify if:
- age 20 - \<65 years,
- body mass index (BMI) ≥ 24 kg/m2,
- HbA1c ≥ 7% (53mmol/mol).
- diabetes antibodies (-)
- diagnosed with T2D within the previous 3 months
You may not qualify if:
- anti-diabetic drugs or diet therapy before participation
- pancreatitis
- coronary artery disease
- liver function impairment
- renal function impairment
- intestinal surgery
- chronic hypoxic diseases (emphysema and cor pulmonale)
- infectious disease
- hematological disease
- systemic inflammatory disease
- cancer
- pregnant, possibly pregnant
- ingesting agents known to influence glucose or lipid metabolism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Zhang L, Hu Y, An Y, Wang Q, Liu J, Wang G. The Changes of Lipidomic Profiles Reveal Therapeutic Effects of Exenatide in Patients With Type 2 Diabetes. Front Endocrinol (Lausanne). 2022 Mar 31;13:677202. doi: 10.3389/fendo.2022.677202. eCollection 2022.
PMID: 35432194DERIVEDLiu J, Hu Y, Xu Y, Jia Y, Miao L, Wang G. Comparison of Exenatide and Metformin Monotherapy in Overweight/Obese Patients with Newly Diagnosed Type 2 Diabetes. Int J Endocrinol. 2017;2017:9401606. doi: 10.1155/2017/9401606. Epub 2017 Nov 20.
PMID: 29358950DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Endocrinology,Principal Investigator
Study Record Dates
First Submitted
September 26, 2017
First Posted
September 29, 2017
Study Start
January 1, 2013
Primary Completion
February 28, 2016
Study Completion
February 28, 2016
Last Updated
October 2, 2017
Record last verified: 2017-09