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Sitagliptin for the Treatment of Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04495881
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Guang Wang, Beijing Chao Yang Hospital

Brief Summary:
Patients newly diagnosed with T2D will be recruited and will receive sitagliptin treatment for 3 months. The gut microbiome of the participants before and after the treatment and the effectiveness of sitagliptin treatment on type 2 diabetes will be evaluated.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Sitagliptin 100mg Phase 4

Detailed Description:
The dipeptidyl peptidase-4 inhibitor sitagliptin is a classic anti-diabetic drug(1) and is widely applied to both scientific research and clinical trial(2-6). This clinical trial aims to study the effectiveness of sitagliptin treatment in T2D patients and related change of gut microbiome. 50 Patients newly diagnosed with T2D will be recruited. With patient's informed consent, patient-related vital signs (such as age, height, weight, body mass index), laboratory indicators (including glycated hemoglobin, glycated albumin, low-density lipoprotein, total cholesterol, triglycerides), fasting blood glucose, insulin levels and Insulin resistance index (HOMA-IR)(7) will be recorded and analyzed. The feces of the patients will be collected to analyze the gut microbiome. All of the patients will receive the sitagliptin treatment for 3 months. The gut microbiome of the patients and the effectiveness of sitagliptin treatment on diabetes will be evaluated at indicated times during follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effectiveness of Sitagliptin for the Treatment of Newly Diagnosed Type 2 Diabetes
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: sitagliptin
sitagliptin 100mg
Drug: Sitagliptin 100mg
Sitagliptin 100mg Qd




Primary Outcome Measures :
  1. HbA1c change [ Time Frame: Changes in HbA1c from baseline at 1 month and 3 months during follow-up ]
    Changes in HbA1c from baseline at 1 month and 3 months during follow-up


Secondary Outcome Measures :
  1. fasting blood glucose change [ Time Frame: Changes in fasting blood glucose from baseline at 1 month and 3 months during follow-up ]
    Changes in fasting blood glucose from baseline at 1 month and 3 months during follow-up

  2. HOMA-IR change [ Time Frame: Changes in HOMA-IR from baseline at 1 month and 3 months during follow-up ]
    Changes in HOMA-IR from baseline at 1 month and 3 months during follow-up

  3. Glycated Albumin(GSA)change [ Time Frame: Changes in Glycated Albumin from baseline at 1 month and 3 months during follow-up ]
    Changes in Glycated Albumin from baseline at 1 month and 3 months during follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18-65 years old newly diagnosed with type 2 diabetes
  • HbA1c ≥ 7%

Exclusion Criteria:

  • The positive of diabetes antibodies
  • Anti-diabetic drugs therapy before participation
  • Pancreatitis
  • Coronary artery disease
  • Liver function impairment
  • Renal function impairment
  • History of intestinal surgery
  • Chronic hypoxic diseases (emphysema and cor pulmonale)
  • Infectious disease
  • Hematological disease
  • Systemic inflammatory disease
  • Cancer
  • Pregnant
  • Ingesting agents known to influence glucose or lipid metabolism;
  • Any antibiotics or probiotics in the past three months prior to the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495881


Contacts
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Contact: Jia Liu, MD 010-85231710 liujia0116@126.com
Contact: Yan Duan, MD 010-85231711

Locations
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China, Beijing
Beijing Chao-Yang Hospital, Capital Medical University Recruiting
Beijing, Beijing, China
Contact: Jia liu, MD    861085231710    liujia0116@126.com   
Sponsors and Collaborators
Beijing Chao Yang Hospital
Investigators
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Principal Investigator: Guang Wang, MD Beijing Chao Yang Hospital
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Responsible Party: Guang Wang, Professor and Director, Department of Endocrinology, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT04495881    
Other Study ID Numbers: 2020-DM-Sitagliptin
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020

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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
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action