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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02131272
• Date of registration: 02/05/2014
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public 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 iDEAt2
• Scientific title: A 26-week Open Label, Randomised, 2-armed, Parallel Group, Multi-centre Trial Investigating Efficacy and Safety of Insulin Detemir Versus Insulin Neutral Protamine Hagedorn in Combination With the Maximum Tolerated Dose of Metformin and Diet/Exercise on Glycaemic Control in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on the Maximum Tolerated Dose of Metformin ± Other Oral Antidiabetic Drug(s) ± Basal Insulin
• Date of first enrolment: June 11, 2014
• Target sample size: 42
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02131272
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, Croatia, Egypt, Germany, Greece, Hungary, India, Israel, Italy, Korea, Republic of, Lebanon, Malaysia, Mexico, Morocco, Poland, Portugal, Russian Federation, Serbia, South Africa, Spain, Taiwan, Turkey, United States

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion Criteria:

- Informed consent from the subject or a legally acceptable representative (LAR) and
child assent from the subject obtained before any trial-related
activities.Trial-related activities are any procedures that are carried out as part of
the trial, including activities to determine suitability for the trial

- Male or female, above or equal to 10 years and below or equal to 17 years at the time
of signing informed consent/assent

- Diagnosis of type 2 diabetes mellitus at least 3 months prior to screening

- Treated with the maximum tolerated stable dose of metformin for at least 3 months
prior to screening or have documented complete metformin intolerance

- HbA1c (glycosylated haemoglobin) above or equal to 7.0% and below or equal to 10.5%
(above or equal to 53 mmol/mol and below or equal to 91 mmol/mol) at screening

Exclusion Criteria:

- Maturity onset diabetes of the young (MODY)

- Fasting C-peptide at screening below 0.6 ng/mL

- Impaired liver function defined as alanine aminotransferase (ALT) above or equal to
2.5 times upper normal limit

- Known proliferative retinopathy or maculopathy requiring acute treatment as judged by
the investigator

- Treatment with any medication for the indication of diabetes or obesity other than
stated in the inclusion criteria in a period of 3 months before the day of screening



Age minimum: 10 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Diabetes

Intervention(s)

Drug: Insulin detemir

Behavioral: Diet/exercise

Drug: Insulin NPH

Primary Outcome(s)

Change in HbA1c (Glycosylated Haemoglobin) [Time Frame: week 0, week 26]

Secondary Outcome(s)

Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes [Time Frame: Weeks 0 - 26]

Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes [Time Frame: Weeks 0 - 26]

Incidence of Adverse Events (AEs) [Time Frame: weeks 0 - 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 [Time Frame: At week 26]

Change in Body Weight Standard Deviation Score (SDS) [Time Frame: 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. [Time Frame: At week 26]

Secondary ID(s)

2015-1316

2013-005500-33

U1111-1151-4056

NN304-4093

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/09/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02131272