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

Capital Medical University

Status and phase: Completed; Phase 4

Conditions: Type2 Diabetes

Treatments: Drug: Exenatide or metformin hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03297879

2015-科 144

Details and patient eligibility

About

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).

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

exenatide group

Experimental group

Description:

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

Treatment:

Drug: Exenatide or metformin hydrochloride

metformin group

Active Comparator group

Description:

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

Treatment:

Drug: Exenatide or metformin hydrochloride