Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036504
Status:
COMPLETED
Last Update Posted:
2010-10-13
First Post:
2002-05-10
Brief Title:
Efficacy and Safety of Twice-Daily Insulin Lispro Low Mixture Compared to a Once-Daily Long Acting Insulin Comparator in Patients Who Have Been Using One or More Oral Antihyperglycemic Agents Without Insulin
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Efficacy and Safety of Twice-Daily Insulin Lispro Low Mixture Compared to a Once-Daily Long Acting Insulin Comparator in Patients New to Insulin Therapy Who Were Inadequately Controlled on Oral Agents
Status:
COMPLETED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this study are to determine 1 If patients taking insulin lispro LM with metformin will have better overall control of their blood sugar than patients taking a long acting insulin comparator with metformin 2 If there is a difference in the way the two treatments affect blood sugar control before and after meals and at night 3 If there is a difference in the insulin dose required with the two treatments 4 If there is a difference in the numbers of times patients experience low blood sugar with the two treatments 5 If there is a difference in the effect on patientss body weight
Detailed Description:
The aim of the present study is to compare two treatments - LM twice daily plus metformin two or three times daily versus a long acting insulin comparator once daily plus metformin two or three times daily - in patients with type 2 diabetes who are currently using a regimen of one or more oral antihyperglycemic agents
The primary objective of this study is to demonstrate that in patients with type 2 diabetes who are new to insulin hemoglobin A1c at endpoint will be lower after treatment with insulin lispro LM twice daily plus metformin than after treatment with a long acting insulin comparator once daily plus metformin
This will be a multicenter randomized open-label crossover study comparing twice-daily insulin lispro LM plus two- or three-times-daily metformin to a once-daily long acting insulin comparator plus two- or three-times-daily metformin in patients with type 2 diabetes who were receiving one or more oral antihyperglycemic agents without insulin prior to the study
Following an 8 -2 week lead-in period consisting of treatment with NPH once daily at bedtime plus metformin two or three times daily approximately 100 eligible patients will be randomized to one of two sequence groups so that there are approximately 50 patients in each group One group will receive 4 months of insulin lispro LM administered immediately before the morning and evening meals plus metformin two or three times daily followed by 4 months of a once-daily long acting insulin comparator at bedtime plus metformin two or three times daily The other group will receive the reverse sequence
The primary objective of this study is to demonstrate that in patients with type 2 diabetes who are new to insulin hemoglobin A1c at endpoint will be lower after treatment with insulin lispro LM twice daily plus metformin than after treatment with a long acting insulin comparator once daily plus metformin
This will be a multicenter randomized open-label crossover study comparing twice-daily insulin lispro LM plus two- or three-times-daily metformin to a once-daily long acting insulin comparator plus two- or three-times-daily metformin in patients with type 2 diabetes who were receiving one or more oral antihyperglycemic agents without insulin prior to the study
Following an 8 -2 week lead-in period consisting of treatment with NPH once daily at bedtime plus metformin two or three times daily approximately 100 eligible patients will be randomized to one of two sequence groups so that there are approximately 50 patients in each group One group will receive 4 months of insulin lispro LM administered immediately before the morning and evening meals plus metformin two or three times daily followed by 4 months of a once-daily long acting insulin comparator at bedtime plus metformin two or three times daily The other group will receive the reverse sequence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| F3Z-MC-IOND | None | None | None |