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

NCT03458715 | Unknown Phase 4

• 1 other identifier: 17MMHIS083
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Keywords

SGLT2 inhibitor; DPP4 inhibitor

Outcome Measures

Primary Outcomes (1)

• Glycated hemoglobin (HbA1c)

  change in glycated hemoglobin (HbA1c) in percentage from baseline to week 24

  measurement at baseline, 12 week and 24 week

Secondary Outcomes (4)

• Fasting blood glucose

  measurement at baseline, 12 week and 24 week

• Postprandial blood glucose

  measurement at baseline, 12 week and 24 week

• Body weight

  measurement at baseline, 12 week and 24 week

• Hypoglycemia event

  recorded at 12 week and 24 week

Study Arms (2)

SGLT2 inhibitor (Empagliflozin 25 MG)

EXPERIMENTAL

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)

DPP4 inhibitor (Linagliptin 5 MG)

ACTIVE COMPARATOR

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)

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.

Also known as: Jardiance

SGLT2 inhibitor (Empagliflozin 25 MG)

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.

Also known as: Trajenta

DPP4 inhibitor (Linagliptin 5 MG)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital

Taipei, 10449, Taiwan

RECRUITING

Related Publications (2)

• Zeng YH, Liu SC, Lee CC, Sun FJ, Liu JJ. Effect of empagliflozin versus linagliptin on body composition in Asian patients with type 2 diabetes treated with premixed insulin. Sci Rep. 2022 Oct 12;12(1):17065. doi: 10.1038/s41598-022-21486-9.

  PMID: 36224294 DERIVED

• Liu SC, Lee CC, Chuang SM, Sun FJ, Zeng YH. Comparison of efficacy and safety of empagliflozin vs linagliptin added to premixed insulin in patients with uncontrolled type 2 diabetes: A randomized, open-label study. Diabetes Metab. 2021 May;47(3):101184. doi: 10.1016/j.diabet.2020.08.001. Epub 2020 Aug 19.

  PMID: 32827752 DERIVED

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitors; empagliflozin; Dipeptidyl-Peptidase IV Inhibitors; Linagliptin

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Protease Inhibitors; Enzyme Inhibitors; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Central Study Contacts

Yi-Hong Zeng, MD

CONTACT

+886-975835827; starrydouchain@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: March 8, 2018
• Study Start: September 21, 2017
• Primary Completion: September 21, 2018
• Study Completion: November 21, 2018
• Last Updated: March 8, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)