NCT03297879

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

Beijing Chao-Yang Hospital, Capital Medical University

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Beijing Chao Yang Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-02-28
• Completion: 2016-02-28
• First posted: 2017-09-29
• Last updated: 2017-10-02