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Clinical Trial Details

Trial ID: L2965
Source ID: NCT02131272
Associated Drug: Insulin Detemir
Title: A Trial Investigating the Efficacy and Safety of Insulin Detemir Versus Insulin NPH in Combination With Metformin and Diet/Exercise in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin With or Without Other Oral Antidiabetic Drug(s) With or Without Basal Insulin
Acronym: iDEAt2
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02131272/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin detemir|DRUG: Insulin NPH|BEHAVIORAL: Diet/exercise
Outcome Measures: Primary: Change in HbA1c (Glycosylated Haemoglobin), Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26., week 0, week 26 | Secondary: Change in Body Weight Standard Deviation Score (SDS), Change in body weight standard deviation score (SDS) from baseline to week 26. In order to reduce the variability in body weight measurements, SDS were calculated. SDS for weight was derived by comparing the actual measurements with standard growth charts for the United States. Standard values provided by the standard growth charts according to the subject's sex and age at the time of the measurement were used to calculate the SDS., week 0, week 26|Proportion of Subjects Achieving HbA1c Below 7.0%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment., Proportion of subjects achieving HbA1c \<7.0% is presented as percentage of subjects achieving HbA1c \<7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) within the last 14 weeks of treatment., At week 26|Proportion of Subjects Achieving HbA1c Below 7.5%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment, Proportion of subjects achieving HbA1c below 7.5% is presented as percentage of subjects achieving HbA1c \<7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) within the last 14 weeks of treatment., At week 26|Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes, The total number of blood glucose confirmed symptomatic nocturnal (time of onset between 23:00 and 06.59 both inclusive) severe (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed symptomatic hypoglycaemic episodes (plasma glucose value \<3.1 mmol/L \[56 mg/dL\] with symptoms consistent with hypoglycaemia) experienced by the subjects during the trial., Weeks 0 - 26|Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes, Total number of treatment emergent severe (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed symptomatic hypoglycaemic episodes (plasma glucose value \<3.1 mmol/L \[56 mg/dL\] with symptoms consistent with hypoglycaemia) experienced by the subjects during the trial., Weeks 0 - 26|Incidence of Adverse Events (AEs), The total number of treatment emergent adverse events (the onset of the adverse event is on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration) reported during the 26 weeks of treatment., weeks 0 - 26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE3
Enrollment: 42
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-06-11
Completion Date: 2016-06-14
Results First Posted: 2017-09-01
Last Update Posted: 2018-09-10
Locations: Novo Nordisk Investigational Site, Tucson, Arizona, 85724, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90027, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32207, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32256, United States|Novo Nordisk Investigational Site, Pembroke Pines, Florida, 33026, United States|Novo Nordisk Investigational Site, Tallahassee, Florida, 32308, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30322, United States|Novo Nordisk Investigational Site, Silver Spring, Maryland, 20910, United States|Novo Nordisk Investigational Site, Washington, Maryland, 20011, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89148, United States|Novo Nordisk Investigational Site, Buffalo, New York, 14203, United States|Novo Nordisk Investigational Site, Cleveland, Ohio, 44195-0001, United States|Novo Nordisk Investigational Site, Toledo, Ohio, 43606, United States|Novo Nordisk Investigational Site, Hershey, Pennsylvania, 17033, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19104, United States|Novo Nordisk Investigational Site, Pittsburgh, Pennsylvania, 15224, United States|Novo Nordisk Investigational Site, Providence, Rhode Island, 02903, United States|Novo Nordisk Investigational Site, Columbia, South Carolina, 29203, United States|Novo Nordisk Investigational Site, Memphis, Tennessee, 38119, United States|Novo Nordisk Investigational Site, Amarillo, Texas, 79106, United States|Novo Nordisk Investigational Site, Edinburg, Texas, 78539, United States|Novo Nordisk Investigational Site, Norfolk, Virginia, 23507, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53226, United States|Novo Nordisk Investigational Site, Caba, C1425DUC, Argentina|Novo Nordisk Investigational Site, Aparecida de Goiania, Goias, 74935-530, Brazil|Novo Nordisk Investigational Site, Porto Alegre, Rio Grande Do Sul, 91350-250, Brazil|Novo Nordisk Investigational Site, São Paulo, Sao Paulo, 01223-001, Brazil|Novo Nordisk Investigational Site, São Paulo, Sao Paulo, 01228-000, Brazil|Novo Nordisk Investigational Site, Zagreb, 10000, Croatia|Novo Nordisk Investigational Site, Alexandria, 21131, Egypt|Novo Nordisk Investigational Site, Cairo, 11562, Egypt|Novo Nordisk Investigational Site, Cairo, 11628, Egypt|Novo Nordisk Investigational Site, Ludwigshafen, 67059, Germany|Novo Nordisk Investigational Site, Neuwied, 56564, Germany|Novo Nordisk Investigational Site, Goudi/ Athens, GR-11527, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR 54642, Greece|Novo Nordisk Investigational Site, Budapest, 1023, Hungary|Novo Nordisk Investigational Site, Budapest, 1083, Hungary|Novo Nordisk Investigational Site, Miskolc, 3501, Hungary|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500072, India|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500082, India|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380007, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560002, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560034, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560045, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600 013, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700032, India|Novo Nordisk Investigational Site, Beer Sheva, 84101, Israel|Novo Nordisk Investigational Site, Haifa, 31096, Israel|Novo Nordisk Investigational Site, Ancona, 60123, Italy|Novo Nordisk Investigational Site, Firenze, 50139, Italy|Novo Nordisk Investigational Site, Seoul, 05030, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 135-720, Korea, Republic of|Novo Nordisk Investigational Site, Beirut, Lebanon|Novo Nordisk Investigational Site, Hazmieh, 9615, Lebanon|Novo Nordisk Investigational Site, Lebanon - Beirut, 9611, Lebanon|Novo Nordisk Investigational Site, Kota Kinabalu, 88996, Malaysia|Novo Nordisk Investigational Site, Kuala Lumpur, 59100, Malaysia|Novo Nordisk Investigational Site, Seremban, 70300, Malaysia|Novo Nordisk Investigational Site, Seri Manjung, 32040, Malaysia|Novo Nordisk Investigational Site, Puebla, 72190, Mexico|Novo Nordisk Investigational Site, Casablanca, 20000, Morocco|Novo Nordisk Investigational Site, Fès, 30000, Morocco|Novo Nordisk Investigational Site, Marrakech, 40000, Morocco|Novo Nordisk Investigational Site, Rabat, 10000, Morocco|Novo Nordisk Investigational Site, Wroclaw, 50-311, Poland|Novo Nordisk Investigational Site, Lisboa, 1250-230, Portugal|Novo Nordisk Investigational Site, Izhevsk, 426009, Russian Federation|Novo Nordisk Investigational Site, Stavropol, 355017, Russian Federation|Novo Nordisk Investigational Site, Tomsk, 634034, Russian Federation|Novo Nordisk Investigational Site, Nis, 18 000, Serbia|Novo Nordisk Investigational Site, Lenasia, Gauteng, 1827, South Africa|Novo Nordisk Investigational Site, Pretoria, Gauteng, 0181, South Africa|Novo Nordisk Investigational Site, Observatory, Western Cape, 7925, South Africa|Novo Nordisk Investigational Site, Esplugues Llobregat(Barcelona), 08950, Spain|Novo Nordisk Investigational Site, Taichung, 404, Taiwan|Novo Nordisk Investigational Site, Taoyuan, 333, Taiwan|Novo Nordisk Investigational Site, Adana, 01130, Turkey|Novo Nordisk Investigational Site, Ankara, 06100, Turkey|Novo Nordisk Investigational Site, Istanbul, 34093, Turkey|Novo Nordisk Investigational Site, Istanbul, 34890, Turkey|Novo Nordisk Investigational Site, Kayseri, 38010, Turkey
URL: https://clinicaltrials.gov/show/NCT02131272

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress