Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488527
Status:
COMPLETED
Last Update Posted:
2010-09-13
First Post:
2007-06-19
Brief Title:
DOMME Dose Optimization Multicentric Mexican Evaluation
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Multicentric Open Label Clinical Trial Use of Optimal Method to Initiate and Maintain Lantus Therapy Insulin Glargine in Combination With Hypoglycemic Agents Assessing the Resulting Metabolic Control and the Safety in T2 Diabetes Mellitus Patients
Status:
COMPLETED
Status Verified Date:
2010-09
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:
DOMME
Brief Summary:
To evaluate the efficiency of Lantus plus combined oral hypoglycaemic agents in terms of respondents percentage The respondent is defined as the person achieving a value in the final determination of HbA1c 7 as its absolute value andor a decreasing in the final value of HbA1c of more than 12 compared with the initial value final HbA1c vs initial HbA1c
Describe the glycemia levels and body weight change in the two response groups respondents and non-respondents
Describe the adverse events Evaluate the safety of using the medication according to the incidence and relevance of the hypoglycemia events symptomatic diurnal nocturnal severe
Estimate the intra-patient variability of the fasting glycemia
Describe the glycemia levels and body weight change in the two response groups respondents and non-respondents
Describe the adverse events Evaluate the safety of using the medication according to the incidence and relevance of the hypoglycemia events symptomatic diurnal nocturnal severe
Estimate the intra-patient variability of the fasting glycemia
Detailed Description:
None
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