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The comparative study of efficacy and safety in the treatment with mixed-type insulin to combined therapy with long-acting insulin analog and GLP-1 recepter agonist in type 2 DM.

The comparative study of efficacy and safety in the treatment with mixed-type insulin to combined therapy with long-acting insulin analog and GLP-1 recepter agonist in type 2 DM. - The comparative study from mixed-type insulin to long-acting insulin analog and GLP-1 recepter agonist.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016628
Enrollment
10
Registered
2015-02-25
Start date
2014-12-02
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

Glargine and Lixisenatide 20 microgram

Sponsors

Hyogo College Of Medicine Division of Diabetes,Endocrinology and Metabolism,Department of Internal Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patients with type 2 diabetes mellitus treated with twice daily insulin injection of premixed insulin value of HbA1c more than 7.0% value of BMI more than 22

Exclusion criteria

Exclusion criteria: Type 1 diabetes mellitus Subjects who have been experienced severe ketosis, diabetic coma or precoma within 6 months Subjects in pregnant women, lactating women, the potential or planned are pregnant Subjects with severe infection, before and just after surgery or severe injury Subjects treated with adrenocorticosteroid Subjects with severe hepatic dysfunction Subjects with impaired insulin secretion Subjects with a history of pancreatitis or with a pancreatitis Subjects with a history of a malignant tumor or with a malignant tumor Subjects who have been determined to be unsuitable for the attending physician

Design outcomes

Primary

MeasureTime frame
Changes of HbA1c, GA and 1.5-AG Changes of the fasting blood glucose level Changes of 2 hours postprandial blood glucose level Achievement of HbA1c less than 7% Changes of SMBG

Secondary

MeasureTime frame
Changes of body weight Changes of lipids Changes of the insulin dose Patient's questionnaire of QOL and feeding behavior Frequency of hypoglycemia

Countries

Japan

Contacts

Public ContactFumihiro Ochi

Hyogo College Of Medicine Division of Diabetes,Endocrinology and Metabolism,Department of Internal Medicine

ochifumi@hyo-med.ac.jp0798-45-6111

Outcome results

None listed

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