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Patient satisfaction, efficacy and safety of combination therapy with lixisenatide and basal insulin in patients with type 2 diabetes

Patient satisfaction, efficacy and safety of combination therapy with lixisenatide and basal insulin in patients with type 2 diabetes - Patient satisfaction of combination therapy with lixisenatide and basal insulin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012697
Enrollment
34
Registered
2013-12-25
Start date
2013-12-25
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

Interventions

Lixisenatide group: In type 2 diabetic patients treated with multiple insulin injection therapy, discontinue rapid-acting insulin and add on lixisenatide at 20ug. Continue basal insulin. Multiple i

Sponsors

Hokkaido University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients whose HbA1c were >=6.0%, <9.0%, type 2 diabetic patients 2) Patients treated with multiple insulin injection therapy for more than 3 months 3) Patients whose total dose of daily insulin were <=30 units.

Exclusion criteria

Exclusion criteria: 1) Patients who have history of diabetic ketoacidosis, or diabetic coma in the past 6 months 2) Patients who are pregnant or in lactation period 3) Patients with serious infectious disease, before operation, serious trauma 4) Patients who receive steroid therapy 5) Patients with severe liver dysfunction 6) Patients with type 1 diabetes 7) Patients with disorder of insulin secretion whose fasting serum C-peptide <0.5ng/ml 8) Patients with hypersensitivity to these medicines 9) Patients who have history of pancreas disease 10) Patients who have history of cancer 11) Patients receiving with GLP-1 receptor agonist or he DPP-4 inhibitor in the past 3 months

Design outcomes

Primary

MeasureTime frame
Diabetes Treatment Satisfaction Questionnaire(DTSQ) at 0 and 12 weeks after switching from multiple insulin injection therapy to combination therapy with lixisenatide and basal insulin

Secondary

MeasureTime frame
The daily profile of blood glucose, changes of HbA1c and body weight at 0 and 12 weeks after switching from multiple insulin injection therapy to combination therapy with lixisenatide and basal insulin Incidence of hypoglycemia

Countries

Japan

Contacts

Public ContactAkinobu Nakamura

Hokkaido University Hospital Department of Internal Medicine II

akinbo@tim.hi-ho.ne.jp011-706-5915

Outcome results

None listed

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