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Clinical Trial Details

Trial ID: L7263
Source ID: NCT01589653
Associated Drug: Biphasic Insulin Aspart 30
Title: Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01589653/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: biphasic insulin aspart 30|DRUG: biphasic insulin aspart 30
Outcome Measures: Primary: Change in HbA1c From Baseline, Change in HbA1c (%) from baseline to the end of the treatment period., Week 0, week 20 | Secondary: Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline, Change in FPG (laboratory values) from baseline to the end of the treatment period, Week 0, week 20|Number of Hypoglycaemic Episodes During the Trial From Baseline, The number of hypoglycaemic episodes (a blood glucose level of approximately 2.8 mmol/L \[50 mg/dL\] or plasma glucose level 3.1 mmol/L \[56 mg/dL\]) during the trial., Week 20|Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D), Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included an overall score as well the subscale scores (daily life, diabetes management, compliance and psychological health). The scores were transformed to a 0-100 scale with higher scores indicating a better health state., Week 0, week 20|Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden, Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included a subscale score -treatment burden. The scores were transformed to a 0-100 scale with higher scores indicating a better health state., Week 0, week 20
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 155
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-05-26
Completion Date: 2015-07-09
Results First Posted: 2016-08-09
Last Update Posted: 2017-07-11
Locations: Novo Nordisk Investigational Site, Alexandria, 21131, Egypt|Novo Nordisk Investigational Site, Beni-Suef, 62511, Egypt|Novo Nordisk Investigational Site, Cairo, 11562, Egypt|Novo Nordisk Investigational Site, Bandung, 40161, Indonesia|Novo Nordisk Investigational Site, Malang, 65111, Indonesia|Novo Nordisk Investigational Site, Casablanca, 20100, Morocco|Novo Nordisk Investigational Site, Marrakech, 40000, Morocco|Novo Nordisk Investigational Site, Jeddah, 80215, Saudi Arabia|Novo Nordisk Investigational Site, Riyadh, 11211, Saudi Arabia|Novo Nordisk Investigational Site, Riyadh, 11426, Saudi Arabia|Novo Nordisk Investigational Site, Taif, 21944, Saudi Arabia|Novo Nordisk Investigational Site, Tunis, 1007, Tunisia|Novo Nordisk Investigational Site, Tunis, 1008, Tunisia|Novo Nordisk Investigational Site, Ha Noi City, Vietnam|Novo Nordisk Investigational Site, Ho Chi Minh City, Vietnam
URL: https://clinicaltrials.gov/show/NCT01589653

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress