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The Efficacy of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase-4 Inhibitor in Type 2 Diabetes Patients With Premix Insulin

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ClinicalTrials.gov Identifier: NCT03458715
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Mackay Memorial Hospital

Brief Summary:
The population of type 2 diabetes increased enormously worldwide. As disease progression, uncontrolled type 2 diabetes patients need multiple daily insulin injections, but the risk of body weight gain and hypoglycemia will increase. In recent years, the newly oral anti-hypoglycemic agents developed, such as dipeptidyl peptidase-4 inhibitors (DPP4i) and sodium-glucose co-transporter 2 inhibitors (SGLT2i). The former indirectly stimulate insulin secretion and suppress glucagon through increase incretin. The later inhibit re-absorption of blood glucose in proximal renal tubule to improve hyperglycemia. According to the guideline published in 2017 by American diabetes Associations, if patients received premix insulin injections twice daily and their glycemic control can't meet the target, increase the frequency of injection such as basal bolus would be considered. However, it is difficult for some patients and it may cause more hypoglycemia and gain of body weight. Because previous report revealed dipeptidyl peptidase-4 inhibitors or sodium-glucose co-transporter 2 inhibitors added to insulin resulted in better glycemic control, but there was no direct comparison, so we design this study to observe the efficacy of these two drugs in uncontrolled diabetes patient received twice daily insulin injections.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Drug: SGLT2 inhibitor (Empagliflozin 25 MG) Drug: DPP4 inhibitor (Linagliptin 5 MG) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase 4 Inhibitor Added to Premix Insulin Injection Twice Daily in Uncontrolled Type 2 Diabetes Patients
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : September 21, 2018
Estimated Study Completion Date : November 21, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SGLT2 inhibitor (Empagliflozin 25 MG)
We add SGLT2 inhibitor (Empagliflozin 25 MG, oral, once daily) to type 2 diabetes patient poorly controlled with premix insulin therapy for 6 months.
Drug: SGLT2 inhibitor (Empagliflozin 25 MG)
We randomized add SGLT2 inhibitor (Empagliflozin 25 MG) or DPP4 inhibitor (Linagliptin 5 MG) to type 2 diabetes patient poorly controlled with premix insulin therapy.
Other Name: Jardiance

Active Comparator: DPP4 inhibitor (Linagliptin 5 MG)
We add DPP4 inhibitor (Linagliptin 5 MG, oral, once daily) to type 2 diabetes patient poorly controlled with premix insulin therapy.for 6 months.
Drug: DPP4 inhibitor (Linagliptin 5 MG)
We randomized add SGLT2 inhibitor (Empagliflozin 25 MG) or DPP4 inhibitor (Linagliptin 5 MG) to type 2 diabetes patient poorly controlled with premix insulin therapy.
Other Name: Trajenta




Primary Outcome Measures :
  1. Glycated hemoglobin (HbA1c) [ Time Frame: measurement at baseline, 12 week and 24 week ]
    change in glycated hemoglobin (HbA1c) in percentage from baseline to week 24


Secondary Outcome Measures :
  1. Fasting blood glucose [ Time Frame: measurement at baseline, 12 week and 24 week ]
    change in fasting blood glucose in mg/dl from baseline to week 24

  2. Postprandial blood glucose [ Time Frame: measurement at baseline, 12 week and 24 week ]
    change in postprandial blood glucose in mg/dl from baseline to week 24

  3. Body weight [ Time Frame: measurement at baseline, 12 week and 24 week ]
    change in body weight in kilogram from baseline to week 24

  4. Hypoglycemia event [ Time Frame: recorded at 12 week and 24 week ]
    documented hypoglycemia (glucose monitor <70mg/dl with hypoglycemia associated symptoms) from baseline to week 24



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes patient received premix insulin twice daily and HbA1c>7%
  • >20 years old

Exclusion Criteria:

  • Type 1 diabetes and gestational diabetes
  • Diabetic ketoacidosis in previous 6 months
  • Urinary tract infection in previous 6 months
  • Pancreatitis in previous 6 months
  • estimated GFR<45 mL/min/1.73m2
  • Patient whom already received DPP4 inhibitor or SGLT2 inhibitor

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): NCT03458715


Contacts
Contact: Yi-Hong Zeng, MD +886-975835827 starrydouchain@yahoo.com.tw

Locations
Taiwan
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 10449
Contact: Yi-Hong Zeng, MD    +886-2-25433535 ext 2174    starrydouchain@yahoo.com.tw   
Sub-Investigator: Sung-Chen Liu, MD         
Sub-Investigator: Chun-Chuan Lee, MD         
Sponsors and Collaborators
Mackay Memorial Hospital

Responsible Party: Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT03458715     History of Changes
Other Study ID Numbers: 17MMHIS083
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mackay Memorial Hospital:
SGLT2 inhibitor
DPP4 inhibitor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Empagliflozin
Insulin
Linagliptin
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action