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Comparison of Exenatide and Metformin Monotherapy in Overweight/Obese Patients With Newly Diagnosed Type 2 Diabetes

NCT ID: NCT03297879

Last Updated: 2017-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-01

Study Completion Date

2016-02-28

Brief Summary

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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).

Detailed Description

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The present study was a prospective, nonrandomized, interventional study.The drug-naïve, overweight or obese patients with newly diagnosed T2D were consecutively enrolled. The inclusion criteria: 1) age 20 - \<65 years, 2) body mass index (BMI) ≥ 24 kg/m2 \[7\], and 3) HbA1c ≥ 7% (53mmol/mol). An oral glucose tolerance test was performed during the screenings. All of the patients have no diabetes antibodies and were diagnosed with T2D within the previous 3 months, according to the ADA diagnostic criteria. None of the patients had administered anti-diabetic drugs or diet therapy before participation. Neither of the patients presented any history of 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, or cancer. Patients who were pregnant, possibly pregnant, or ingesting agents known to influence glucose or lipid metabolism were also excluded.

Conditions

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Type2 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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exenatide group

The drug-naïve, overweight or obese patients with newly diagnosed T2D

Group Type EXPERIMENTAL

Exenatide or metformin hydrochloride

Intervention Type DRUG

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.

metformin group

The drug-naïve, overweight or obese patients with newly diagnosed T2D

Group Type ACTIVE_COMPARATOR

Exenatide or metformin hydrochloride

Intervention Type DRUG

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.

Interventions

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Exenatide or metformin hydrochloride

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guang Wang

Director of Endocrinology,Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 35432194 (View on PubMed)

Liu 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.

Reference Type DERIVED
PMID: 29358950 (View on PubMed)

Other Identifiers

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2015-科 144

Identifier Type: -

Identifier Source: org_study_id