| Trial ID: | L5037 |
| Source ID: | NCT00698802
|
| Associated Drug: |
Ex1000
|
| Title: |
Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: EX1000|DRUG: biphasic human insulin
|
| Outcome Measures: |
Primary: HbA1c, after 8 weeks of treatment | Secondary: HbA1c, For the duration of the trial|Fructosamine, For the duration of the trial|FPG, For the duration of the trial|4-point SMPG profiles, For the duration of the trial|Incidence of hypoglycaemic episodes, For the duration of the trial|Frequency and severity of adverse events (including injection site reactions), For the duration of the trial|Laboratory safety parameters (haematology, biochemistry and lipids), For the duration of the trial|Physical examination and vital signs, For the duration of the trial|Total daily insulin dosages, For the duration of the trial
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
397
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-06
|
| Completion Date: |
2009-03
|
| Results First Posted: |
|
| Last Update Posted: |
2015-04-14
|
| Locations: |
Vijayawada, 520002, India|Johannesburg, Gauteng, 2193, South Africa|Abu Dhabi, 51900, United Arab Emirates
|
| URL: |
https://clinicaltrials.gov/show/NCT00698802
|
