Skip to main content
OpenTrials
Completed

NCT Number: NCT03297879

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exenatide or metformin hydrochloride

Drug

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.

Primary outcomes

  1. The change of HbA1c

    Time frame: baseline and 12 weeks

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study title

Beijing Chao-Yang Hospital, Capital Medical University

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 29, 2017
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.