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

Study Overview
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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.

Official Title
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Beijing Chao-Yang Hospital, Capital Medical University

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Drug: Exenatide or metformin hydrochloride


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exenatide group<br>The drug-naïve, overweight or obese patients with newly diagnosed T2D | Drug: Exenatide or metformin hydrochloride<br>* 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.<br>|
| Active Comparator: metformin group<br>The drug-naïve, overweight or obese patients with newly diagnosed T2D | Drug: Exenatide or metformin hydrochloride<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of HbA1c |  | baseline and 12 weeks |