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 (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03458715
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 8.6

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Sep 21, 2017
• Anticipated Primary Completion Date: Sep 21, 2018
• Anticipated Study Completion Date: Nov 21, 2018

Arms and Interventions

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 Names: 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 Names: Trajenta

Outcome Measures

Primary Outcome Measures

1. Glycated hemoglobin (HbA1c) [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 [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 [measurement at baseline, 12 week and 24 week]

   change in postprandial blood glucose in mg/dl from baseline to week 24

3. Body weight [measurement at baseline, 12 week and 24 week]

   change in body weight in kilogram from baseline to week 24

4. Hypoglycemia event [recorded at 12 week and 24 week]

   documented hypoglycemia (glucose monitor <70mg/dl with hypoglycemia associated symptoms) from baseline to week 24

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital	Taipei		Taiwan	10449

Sponsors and Collaborators

• Mackay Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mackay Memorial Hospital
• ClinicalTrials.gov Identifier: NCT03458715
• Other Study ID Numbers: 17MMHIS083
• First Posted: Mar 8, 2018
• Last Update Posted: Mar 8, 2018
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• 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; Empagliflozin; Sodium-Glucose Transporter 2 Inhibitors; Linagliptin; Dipeptidyl-Peptidase IV Inhibitors

Study Results

No Results Posted as of Mar 8, 2018