The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients

• Status: Unknown status
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to investigate the effect of Gliatamin (chonline alphoscerate) on depressive mood in type 2 diabetes patients and demonstrate the impact of improved depressive mood could be influence the patient's quality of life and glycemic control.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University

Criteria

Inclusion Criteria:

• Type 2 diabetic patients

• Age ≥ 50

• Glycemic control: HbA1c ≤ 10.0%

• 10 ≤ Beck Depression Inventory (BDI) <30 points

• Participants who can undergo contraception in case of being in childbearing period

• Understands the study procedure, alternatives, and risks and voluntarily agrees to participate by giving written informed concent

Exclusion Criteria:

• Type 1 diabetes, Secondary diabetes, gestational diabetes

• Ongoing dementia treatment or anti-depressive disorder medication

• Uncontrolled psychiatric disorder

• BDI ≥ 30 points

• Heavy alcoholics

• Underlying chronic liver disease (hemochromatosis, liver cell carcinoma, autoimmune liver disease, liver cirrhosis, chronic viral hepatitis)

• Allergy or hypersensitivity to target medication or any of its components

• Renal failure, moderate or severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m2), or ongoing dialysis

• Abnormal liver function (AST/ALT > x3 upper normal limit)

• History of alcohol or drug abuse in the previous 3 months

• Premenopausal women who are nursing or pregnant

• Human immunodeficiency virus (HIV) or human immunodeficiency virus (AIDS)

• chronic pancreatitis or pancreatic cancer