Comparison of Exenatide and Metformin Monotherapy in Overweight/Obese Patients With Newly Diagnosed Type 2 Diabetes
- Registration Number
- NCT03297879
- Lead Sponsor
- Beijing Chao Yang Hospital
- 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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 230
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description exenatide group Exenatide or metformin hydrochloride The drug-naïve, overweight or obese patients with newly diagnosed T2D metformin group Exenatide or metformin hydrochloride The drug-naïve, overweight or obese patients with newly diagnosed T2D
- Primary Outcome Measures
Name Time Method The change of HbA1c baseline and 12 weeks
- Secondary Outcome Measures
Name Time Method