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

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ClinicalTrials.gov Identifier: NCT03297879
Recruitment Status : Completed
First Posted : September 29, 2017
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Guang Wang, Beijing Chao Yang Hospital

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).

Condition or disease Intervention/treatment Phase
Type2 Diabetes Drug: Exenatide or metformin hydrochloride Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Beijing Chao-Yang Hospital, Capital Medical University
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : February 28, 2016
Actual Study Completion Date : February 28, 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The change of HbA1c [ Time Frame: baseline and 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guang Wang, Director of Endocrinology,Principal Investigator, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT03297879    
Other Study ID Numbers: 2015-科 144
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists