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

JRCT ID: jRCT1031220271

Registered date:15/08/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 15/08/2022
• Target sample size: 100
• Study type: Interventional
• Intervention(s): In this study, patients with type 2 diabetes are recruited, and participants were divided into two groups. For control group, participants receive treatement with insulin degludec (body weight X 0.1 unit) and dapagliflozin 5 mg (dose can be increased up to 10 mg). For study treatment group, participants receive treatment with insulin degludec (body weight X 0.1 unit) and oral semaglutide 3 mg (dose can be increased to 7 mg and 14 mg). For both groups, doses of insulin and oral drugs are titrated according to their glucose levels at each visit.

Outcome(s)

• Primary Outcome: The change in HbA1c between the two groups after 24 weeks of intervention .

Secondary Outcome

1.Glycoalbumin (%)
2.Fasting blood glucose (mg/dL)
3. 2-hour postprandial blood glucose (mg/dL)
4.Systolic blood pressure (mmHg)
5.Diastolic blood pressure (mmHg)
6.Pulse rate (bpm)
7.Lipid profile (TG(mg/dL), HDL-C(mg/dL), LDL-C(mg/dL))
8. eGFR (ml/min/1.73m2)
9.Urinary albumin/creatinine ratio (mg/gCr)
10. Basal insulin dose (units/day)
11. Body weight (kg)
12. Abdominal circumference (cm)
13. Body fat content (kg)
14. Body component skeletal muscle mass (kg)
15. Frequency of hypoglycemia (nonsevere/severe (times/person-year))
16. Other side effects/adverse events
17.C-peptide index ((fasting C-peptide/fasting blood glucose) X 100)
18.HOMA2-IR
19.HOMA2-%beta (%)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Kazuki Orime