Prospective study to assess with Continuous Glucose Monitoring (CGM) the efficacy and safety of switching to insulin glargine 300 U/ml from insulin glargine 100 U/ml in Type 2 Diabetes (T2DM) patients with renal impairment

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518403-22-00

Acronym

LPS17375

Enrollment

100

Registered

2025-01-13

Start date

2022-06-20

Completion date

2025-07-09

Last updated

2025-01-13

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

Conditions

Diabetes mellitus II

Brief summary

Change from baseline to Month 5 in the percentage of Time in Range (TIR)

Detailed description

Mean glucose profile over 24 hours, % Coefficient of variation, % Time below target glucose Range (TBR), % Time above target glucose Range (TAR), Change from baseline to Month 5 in HbA1c, Change from baseline to Month 5 in Fasting Plasma Glucose (FPG), Number of participants with at least one hypoglycemia event, Change from baseline to Month 5 in DTSQc, Number of participants with adverse events

Interventions

DRUGINSULIN GLARGINE

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change from baseline to Month 5 in the percentage of Time in Range (TIR)	—

Secondary

Measure	Time frame
Mean glucose profile over 24 hours, % Coefficient of variation, % Time below target glucose Range (TBR), % Time above target glucose Range (TAR), Change from baseline to Month 5 in HbA1c, Change from baseline to Month 5 in Fasting Plasma Glucose (FPG), Number of participants with at least one hypoglycemia event, Change from baseline to Month 5 in DTSQc, Number of participants with adverse events	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026