Effects of Linagliptin on Hypoglycemia :Hypoglycemic Clamp Test in Japanese T2DM Patients

Not Applicable

• Conditions: Type 2 diabetes

• Registration Number: JPRN-UMIN000014417
• Lead Sponsor: Kansai Electric Power Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-01
• Study Completion: 2015-04-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

(1)Patients with diabetes requiring insulin therapy (insulin intensive therapy, T1DM, etc) (2)Patients currently treated with Insulin, DPP-4inhibitor, GLP-1 receptor agonist within 4 weeks and/or treated with Pioglitazon within 12weeks (3)Patients currently treated with alpha blocker, beta blocker, selective serotonin reuptake inhibitors (4)Patients with history of cerebrovascular and cardiovascular disease (5)Patients with heart failure with NYHA I-IV (6)Patients with renal dysfunction (7)Patients with severe hepatic dysfunction (8)Patients with history of pancreatitis (9)Patients with diabetic retinopathy (proliferative retinopathy, vitreous hemorrhage and more severe condition) (10)Patients with autonomic neuropathy (11)Patients with a history of surgery of gastrointestinal tract (12)Patients with malignant tumor (13)Patients with severe infection, in the perioperative period or with serious injury (14)Excessive alcohol intake (15)Patients with hemoglobin (Hb) <13.0g/dL(male), <12.5g/dL(female) (16)Patients found ineligible as a study patient according to the discretion of the investigator or sub-investigator (17)Patients participating in other clinical studies (18)Pregnant or possibly pregnant women (19)Patients judged as inadequate to participate in present study by investigator or sub-investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To explore the change in the following measurements during hypoglycemic (45mg/dL glucose) clamp at 2 weeks after Linagliptin/Liraglutide treatment: (1)Changes in plasma levels of glucagon (2)Its correlation with biologically intact GIP

Secondary Outcome Measures

Name	Time	Method
To explore the change in the following measurements during hypoglycemic (45mg/dL glucose) clamp at 2weeks after Linagliptin/Liraglutide treatment: (1)ISR, ISR/Glucose (2)Pancreatic and autonomic hormonal response to hypoglycemia(Epinephrine, Norepinephrine, Cortisol, GH)