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Comparison of the efficacy and safety of dulaglutide in combination with insulin compared with insulin alone in daibetes patients who are receiving high dose glucocorticoids therapy: a randomized,open-label trial

Comparison of the efficacy and safety of dulaglutide in combination with insulin compared with insulin alone in daibetes patients who are receiving high dose glucocorticoids therapy: a randomized,open-label trial - Comparison of the efficacy and safety of dulaglutide in combination with insulin compared with insulin alone in daibetes patients who are receiving high dose glucocorticoids therapy: a randomized,open-label trial

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020037
Enrollment
30
Registered
2015-12-02
Start date
2015-12-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus

Interventions

Combination therapy with dulaglutide and insulin group:Injection of 0.75mg dulaglutide once a week, before breakfast Multiple injection of rapid acting insulin and NPH insulin.Adjust the insulin dos

Sponsors

Kanagawa Cardiovascular and Respiratory Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1Patients treated with insulin therapy 2Patients expected to have high-dose steroid(10mg or more of prednisolone each day) during the next 6 months

Exclusion criteria

Exclusion criteria: 1Patients less than 20 years old or 80 years of age or more 2Patients who are pregnant, breastfeeding or may become pregnant 3Type 1 diabetes mellitus patients 4Insulin-dependent diabetes mellitus patients 5Patients with severe infection or severe trauma 6Patients with severe hepatic disease 7Patients with severe renal disease 8Patients with hypopituitarism and/or adrenal insufficiency 9Patients with severe gastroenteric disturbance as exemplified by severe gastro-paresis. 10Patients with a history of pancreatitis 11Patients with malnutrition 12Patients taking DPP4-I,SGLT2I,GLP1 receptor agonists except for dulaglutide 13Patients who considered not eligible for the study by the attending doctor due to other reasons

Design outcomes

Primary

MeasureTime frame
Change of HbA1c at the 24th week

Secondary

MeasureTime frame
Change of date shown below at the 12th and 24th week. HbA1c(at the 12th week),GA,body weight,blood pressure,total cholesterol,triglyceride,LDL-cholesterol,HDL-cholesterol,fasting plasma glucose,c-peptide(at the 24th week),urine albumin(mg/gCr)(at the 24th week),KL-6

Countries

Japan

Contacts

Public ContactJunko Hamai

Kanagawa Cardiovascular and Respiratory Center Department of Endocrinology and Diabetes

femme-de-docilite@hotmail.co.jp045-701-9581

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026