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Liraglutide versus insulin detemir , the effective switch from intensive insulin therapy to the once-daily injection in patients with well controlled type 2 diabetes : a randomized controlled trial

Liraglutide versus insulin detemir , the effective switch from intensive insulin therapy to the once-daily injection in patients with well controlled type 2 diabetes : a randomized controlled trial - Liraglutide versus insulin detemir , the effective switch from intensive insulin therapy to the once-daily injection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007009
Enrollment
90
Registered
2012-01-04
Start date
2012-01-01
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

Type 2 diabetes mellitus

Interventions

Detemir group 1.Intensive insulin therapy is discontinued. 2.The starting dose of insulin detemir is not changed. Add on sitagliptin (50 mg/day). 3.During the first 8 weeks, insulin detemir is titr
= FPG &lt
= 130 mg/dl. Liraglutide group 1.Intensive insulin therapy is discontinued 2.Starting at 0.3mg once daily with weekly increments of 0.3mg , reaching a final daily dose of 0.9mg by the end of the sec
160mg/dl , add on glimepiride 0.5mg and the dose is increased up to 1.0mg if necessary.

Sponsors

Yokohama City Unuversity Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients whose HbA1c(JDS) were <= 6.9% on intensive insulin therapy with insulin dose of <= 30 units.

Exclusion criteria

Exclusion criteria: 1. Patients with history of diabetic ketoacidosis, or diabetic coma within 6 months prior to the study entry. 2. Patients with during pregnancy or lactation. 3. severe infection, before operation, severe trauma 4. Patients who received steroid therapy 5. Patients with history of cardiac failure. 6. Patients with renal insufficiency (serum creatinine > 1.5mg/dl (male) , > 1.3mg/dl (female), e-GFR < 50ml/min). 7. Patients with severe liver dysfunction. 8. Patients with type1 diabetes. 9. Patients with disorder of insulin secretion (serum C-peptide < 0.5ng/ml) 10. Patients who are hypersensitive to these medicines 11. Patients judged to be inappropriate by physicians in charge.

Design outcomes

Primary

MeasureTime frame
HbA1c at 0, 8, 16 and 24 weeks after administration of liraglutide or insulin detemir.

Secondary

MeasureTime frame
Fasting plasma glucose and self-monitoring blood glucose and body weight at 0, 8, 16 and 24 weeks after administration of liraglutide or insulin detemir , Diabetes treatment satisfaction questionnaire (DTSQ) , Frequency of side effects (digestive symptoms, hypoglycemia)

Countries

Japan

Contacts

Public ContactYuichiro Inoue

Yokohama City Unuversity Graduate School of Medicine Department of Endcrinology & Metabolism

hiroshic_w@yahoo.co.jp0457872800

Outcome results

None listed

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