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

September 29, 2017 updated by: Guang Wang, Beijing Chao Yang Hospital

Beijing Chao-Yang Hospital, Capital Medical University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: exenatide group
The drug-naïve, overweight or obese patients with newly diagnosed T2D
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.
Active Comparator: metformin group
The drug-naïve, overweight or obese patients with newly diagnosed T2D
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change of HbA1c
Time Frame: baseline and 12 weeks
baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

February 28, 2016

Study Completion (Actual)

February 28, 2016

Study Registration Dates

First Submitted

September 26, 2017

First Submitted That Met QC Criteria

September 26, 2017

First Posted (Actual)

September 29, 2017

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-科 144

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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