Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069784
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2003-10-01
Brief Title:
The ORIGIN Trial Outcome Reduction With Initial Glargine Intervention
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter International Randomized 2x2 Factorial Design Study to Evaluate the Effects of Lantus Insulin Glargine Versus Standard Care and of Omega-3 Fatty Acids Versus Placebo in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose IFG Impaired Glucose Tolerance IGT or Early Type 2 Diabetes Mellitus The ORIGIN Trial Outcome Reduction With Initial Glargine Intervention
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORIGIN
Brief Summary:
The primary objectives of the ORIGIN study were
To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity andor mortality in people at high risk for vascular disease with either Impaired Fasting Glucose IFG Impaired Glucose Tolerance IGT or early type 2 diabetes
To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG IGT or early type 2 diabetes
The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce
total mortality all causes
the risk of diabetic microvascular outcomes
the rate of progression of IGT or IFG to type 2 diabetes
To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity andor mortality in people at high risk for vascular disease with either Impaired Fasting Glucose IFG Impaired Glucose Tolerance IGT or early type 2 diabetes
To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG IGT or early type 2 diabetes
The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce
total mortality all causes
the risk of diabetic microvascular outcomes
the rate of progression of IGT or IFG to type 2 diabetes
Detailed Description:
The ORIGIN study was conducted by the Population Health Research Institute in Hamilton Ontario Canada working in conjunction with the sponsor and an independent Steering Committee
Routine visits were to occur at 2 4 8 and 16 weeks following randomization then every four months for the rest of the study for all participants
The duration of the study was based on the number of events observed event-driven study and was originally planned to be 5 years In 2008-2009 ORIGINs follow-up was extended by approximately 2 years because of published literature of completed studies suggesting that a longer period of effective glycemic contrast between treatments might be needed to see an effect on cardiovascular events
Routine visits were to occur at 2 4 8 and 16 weeks following randomization then every four months for the rest of the study for all participants
The duration of the study was based on the number of events observed event-driven study and was originally planned to be 5 years In 2008-2009 ORIGINs follow-up was extended by approximately 2 years because of published literature of completed studies suggesting that a longer period of effective glycemic contrast between treatments might be needed to see an effect on cardiovascular events
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 |
|---|---|---|---|
| HOE9014032 | OTHER | previous Aventis study number | None |