daytime sleepness
Conditions
Interventions
self-placebo group:placebo with metformin
self-experimental group:Alogliptin with metformin
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) T2DM patients diagnosed according to the 1999 World Health Organization criteria; (2) male; (3) aged 30 to 60 years old; (4) HbA1c is less than or equal to 8.5%; (5) body mass index is less than 28Kg/m2; (6) a stable doses of metformin monotherapy last longer than or equal to 2 months; (7) there is a decline in the sleep quality assess by Pittsburgh sleep quality index; (8) Agree to experiments and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) patient with chronic diseases (such as chronic heart and respiratory diseases, central nervous system disease, rheumatic disease) which could effect sleep; (2) SDB confirmed by polysomnography; (3) allergy to the DPP-4 inhibitor; (4) patient unable to use metformin or metformin intolerant; (5) chronic gastrointestinal diseases which may influence drug absorption; (6) abnormal liver or renal function (alanine aminotransferase or aspartate aminotransferase is more than 2.5 times of upper limit of the normal value, and / or plasma creatinine is more than 1.2 times of the upper limit of normal value, blood potassium is more than 5.5mmol/L); (7) patient with claustrophobia; (8) patient had participated in other drug trials in the past 3 months; (9) the alcohol, drug abuse or patients with poor compliance; (10) patient with other medical conditions which is not suitable for the study assess by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index;OSLER test results; | — |
Secondary
| Measure | Time frame |
|---|---|
| Beck Depression inventory;sleep architecture;inflammatory factors;endocrine hormone;peptides;HbA1c;Blood glucose;lipid profile; | — |
Countries
China
Contacts
Public ContactAng Li
Peking University First Hospital
Outcome results
None listed