| Trial ID: | L4732 |
| Source ID: | NCT00851903
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00851903/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Insulin Glargine|DRUG: Sitagliptin|DRUG: Metformin
|
| Outcome Measures: |
Primary: HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period), study endpoint: week 12 or earlier in case of premature discontinuation | Secondary: HbA1c: Change From Baseline to Study Endpoint, Change = study endpoint - baseline, baseline, study endpoint: week 12 or earlier in case of premature discontinuation|Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint, SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed). Change = study endpoint - baseline., baseline, study endpoint: week 12 or week 8 if value not available at week 12|7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint, 7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime. Change = study endpoint - baseline., baseline, study endpoint: week 12 or week 8 if value not available at week 12|Insulin Dose, Daily dose at the face-to-face visits, baseline, week 4, week 8, week 12|Number of Patients With at Least One Episode of Symptomatic Hypoglycemia, Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement \<= 70mg/dL \[3.9 mmol/L\], During the treatment period (12 weeks) plus 7 days after last dose|Change in Body Weight From Baseline to Study Endpoint, Change = study endpoint - baseline, baseline, study endpoint: week 12 or week 8 or week 4 depending on last available value
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
112
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-06
|
| Completion Date: |
2011-09
|
| Results First Posted: |
2012-10-04
|
| Last Update Posted: |
2012-10-04
|
| Locations: |
Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, 08807, United States|Sanofi-Aventis Administrative Office, Vienna, Austria|Sanofi-Aventis Administrative Office, Sao Paulo, Brazil|Sanofi-Aventis Administrative Office, Bogota, Colombia|Sanofi-Aventis Administrative Office, Cairo, Egypt|Sanofi-Aventis Administrative Office, Kallithea, Greece|Sanofi-Aventis Administrative Office, Hong Kong, Hong Kong|Sanofi-Aventis Administrative Office, Mumbai, India|Sanofi-Aventis Administrative Office, Natanya, Israel|Sanofi-Aventis Administrative Office, Seoul, Korea, Republic of|Sanofi-Aventis Administrative Office, Beirut, Lebanon|Sanofi-Aventis Administrative Office, Col. Coyoacan, Mexico|Sanofi-Aventis Administrative Office, Gouda, Netherlands|Sanofi-Aventis Administrative Office, Porto Salvo, Portugal|Sanofi-Aventis Administrative Office, Barcelona, Spain|Sanofi-Aventis Administrative Office, Guildford Surrey, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00851903
|
