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

Type2 Diabetes Clinical Trial

Official title:

Beijing Chao-Yang Hospital, Capital Medical University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297879
• Other study ID #: 2015-? 144
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2017
• Last updated: September 29, 2017
• Start date: January 1, 2013
• Est. completion date: February 28, 2016

Study information

• Verified date: September 2017
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: February 28, 2016
• Est. primary completion date: February 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of HbA1c		baseline and 12 weeks