| Trial ID: | L4821 |
| Source ID: | NCT00751114
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients
|
| Acronym: |
EASIE
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00751114/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Insulin Glargine|DRUG: Sitagliptin|DRUG: Metformin
|
| Outcome Measures: |
Primary: HbA1c: Change From Baseline to Study Endpoint, Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period., baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14 | Secondary: HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint, study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint, study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|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). Study endpoint was defined as the last available SMFPG mean value collected on-treatment. Change= study endpoint - baseline, baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value|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 (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|Insulin Dose in the Insulin Glargine Group, Daily dose at the face-to-face visits., visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available value|Lipid Profile: Change From Baseline to Study Endpoint, baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14|Change in Body Weight From Baseline to Study Endpoint, baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value|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 phase (24 weeks) plus 7 days after last dose|Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia, Severe symptomatic hypoglycemia was defined as an event with clinical symptoms which required assistance of another person and with either a Plasma Glucose level \< 36 mg/dL (2 mmol/L) or with a prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, During the treatment phase (24 weeks) plus 7 days after last dose
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
515
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-11
|
| Completion Date: |
2011-07
|
| Results First Posted: |
2012-08-15
|
| Last Update Posted: |
2012-09-10
|
| 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, Istanbul, Turkey|Sanofi-Aventis Administrative Office, Guildford Surrey, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00751114
|
