Type2 Diabetes
Conditions
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.
Interventions
DRUGExenatide 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.
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of HbA1c | baseline and 12 weeks |
Outcome results
None listed