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Effects of Replacing Lantus With Basalin on the Glycemic Variation in Patients With Type 2 Diabetes Mellitus

Effects of Replacing Lantus With Basalin on the Glycemic Variation in Patients

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03631121
Enrollment
100
Registered
2018-08-15
Start date
2018-08-15
Completion date
2019-07-30
Last updated
2019-06-11

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

Conditions

Type2 Diabetes

Brief summary

The study will assess the glycemic variationusing continuous glucose monitoring system in type 2 diabetic patients with euglycemia control respectively when patients was treated with Basalin and one week after changing the insulin into Lantus.

Detailed description

The participants will take continuous glucose monitoring system for 3 days when they change the insulin into Lantus after reach euglycemia control with Basalin treatment for one week.

Interventions

DRUGBasalin to Lantus

continuous glucose monitoring system will used twice when patients are using Basalin and Lantus respectively to assess glycemic variation.

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999; 2. Patients were using Basalin with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 3 month would be recruited into this study; 3. Patients had relatively constant diet and exercise in 2 month before the study. 4. Fasting blood glucose\<6.1mmol/L, and postprandial (or random) blood glucose \<14mmol/L

Exclusion criteria

1. Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure; 2. Patients with severe infectious diseases; 3. Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis; 4. Patients with history of psychiatric disorders and were unsuitable to use CGMS; 5. Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.

Design outcomes

Primary

MeasureTime frameDescription
Change of glycemic variationDay 1-13The changes of glycemic variation before and after drug change

Countries

China

Contacts

Primary ContactMa Jianhua
majianhua196503@126.com8625-52887092

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026