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

Sponsor
Mackay Memorial Hospital
Study ID
NCT03458715
Phase
PHASE4
Status
Unknown

Conditions

  • Type2 Diabetes

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • SGLT2 inhibitor (Empagliflozin 25 MG) — DRUG
    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.
  • DPP4 inhibitor (Linagliptin 5 MG) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Sep 21, 2017
Status verified
Oct 2017
Primary completion
Sep 21, 2018
Completion
Nov 21, 2018

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Glycated hemoglobin (HbA1c) [ Time Frame: measurement at baseline, 12 week and 24 week ]

Central Contacts

Related Studies