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An observational study to optimize treatment by switching to Lixisenatide combined with insulin glargine in patients with type 2 diabetes previously uncontrolled on premixed insulin

An observational study to optimize treatment by switching to Lixisenatide combined with insulin glargine in patients with type 2 diabetes previously uncontrolled on premixed insulin

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041657
Enrollment
Unknown
Registered
2021-01-01
Start date
2020-12-31
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

Diabetes

Interventions

experimental group:Lixisenatide combined with insulin glargine

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patients with type 2 diabetes mellitus were definitely diagnosed; 2. Aged >= 18 and = 19kg/m2 4. Premixed insulin (human insulin or insulin analogues, combined with 0 to 3 kinds of oral hypoglycemic drugs) was used to treat patients with a total daily dose of = 1.0 ng / ml; 7. Patients who can monitor their blood glucose and adjust the dose of insulin glargine under the guidance of doctors; 8. Patients who have signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with type 1 diabetes mellitus; 2. Patients currently using GLP-1 receptor agonists; 3. Pregnant / lactating women; 4. Patients with serum creatinine >= 1.5mg/dl (133umol / L); 5. Patients with active liver disease, jaundice, or ALT / AST >= 2.5 times of the upper normal limit in screening period; 6. Patients with long-term or repeated use of systemic corticosteroids; 7. Diabetic patients with acute complications; 8. Patients with major concomitant diseases or serious complications; 9. Patients allergic to insulin glargine or any of its components; 10. Patients who are allergic to lisinotide or have contraindications to use lisinotide; 11. Patients who have participated in any other clinical research project within 3 months.

Design outcomes

Secondary

MeasureTime frame
FPG;PBG;weight;

Primary

MeasureTime frame
GHbA1c;

Countries

China

Contacts

Public ContactJunqing Zhang

Peking University First Hospital

junqing.zhang@pkufh.com+86 10-83572900

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026