Effects of combination therapy of insulin degludec and oral hypoglycemic agents on hyperglycemia in patients with type 2 diabetes: a randomized controlled study

Phase 2

• Conditions: Type 2 diabetes

• Registration Number: JPRN-jRCT1031220271
• Lead Sponsor: Kazuki Orime

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

(1) Patients with type 2 diabetes aged 20 years or older and less than 80 years old at the time of registration
(2) Gender is irrelevant.
(3) Patients with 9.0% =< HbA1c =< 12.0% at the time of medical checkup.

(4) Patients with blood glucose level of 170 mg/dl or more at any time at the time of examination
(5) Patients must not have received treatment with insulin, GLP-1 receptor agonists, or SGLT2 inhibitors within 8 weeks prior to enrollment.
(6) Patients who provide written consent to participate in this study
(7) Patients taking up to 3 oral hypoglycemic agents
(8) For patients taking oral SU medications, the dose of SU medication should not exceed 2 mg/day for glimepiride, 1.25 mg/day for glibenclamide, and 40 mg/day for gliclazide.

Exclusion Criteria

(1) Patients with type 1 diabetes or secondary diabetes
(2) Patients with severe renal dysfunction (eGFR <30 ml/min/1.73m2)
(3) Patients with severe hepatic dysfunction (AST, ALT > 3 times the upper limit of normal)
(4) Patients on steroids (oral or injectable steroids)
(5) Patients taking atypical antipsychotics
(6) Patients on immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies)
(7) Patients with active carcinoma (however, those who have not received any treatment for it and have no evidence of recurrence, and those who can be judged not to have recurred during this study period will be included)
(8) Patients with severe infections (when symptoms of infection such as fever and diarrhea do not improve after 3 days of antibiotic treatment)
(9) Patients with severe trauma (Injury Severity Score (ISS) anatomical severity > 15)
(10) Patients with contraindications or allergies to the study drug
(11) Patients who are pregnant, may become pregnant, or wish to become pregnant during the study period
(12) Patients who are judged to have difficulty maintaining compliance during the study period
(13) Patients in diabetic coma

Study & Design

• Study Type: Interventional
• Study Design: Not specified