| Trial ID: | L2707 |
| Source ID: | NCT00783744
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Insulin Glargine Combination Therapies in Type II Diabetics
|
| Acronym: |
LAPTOP
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Insulin Glargine|DRUG: Glimepiride|DRUG: Metformin|DRUG: Insulin monotherapy with premixed insulin NPH 30/70
|
| Outcome Measures: |
Primary: Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 %, At endpoint | Secondary: Change of fasting blood glucose, baseline to endpoint|Change of nocturnal & mean daytime blood glucose, baseline to endpoint|Change of fasting plasma glucose, baseline to endpoint and all visits|Frequency of subjects with hypoglycemic events (overall, severe, non-severe, nocturnal, asymptomatic, symptomatic), Baseline to endpoint|Frequency of hypoglycemic events(overall, severe, non-severe, nocturnal, asymptomatic, symptomatic), Baseline to endpoint|Frequency of subjects with FBG ≤ 100 mg/dl (5.5 mmol/l), 100 mg/dl < FBG ≤ 120 mg/dl (5.5 mmol/l < FBG ≤ 6.6 mmol/l), 120 mg/dl < FBG ≤ 150 mg/dl (6.6 mmol/l < FBG ≤ 8.3 mmol/l) and > 150 mg/dl (> 8.3 mmol/l), At endpoint
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
375
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2001-12
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2009-09-28
|
| Locations: |
Sanofi aventis administrative office, Vienna, Austria|Sanofi-aventis administrative office, Helsinki, Finland|Sanofi-aventis administrative office, Paris, France|Sanofi-Aventis Administrative Office, Berlin, Germany|Sanofi-Aventis Administrative Office, Milan, Italy|Sanofi-Aventis Administrative Office, Gouda, Netherlands|Sanofi-Aventis Administrative Office, Barcelona, Spain|Sanofi-Aventis Administrative Office, Bromma, Sweden|Sanofi-Aventis Administrative Office, Geneva, Switzerland|Sanofi-Aventis Administrative Office, Guildford, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT00783744
|
