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)

Novo Nordisk

Status and phase: Terminated; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: Insulin detemir; Behavioral: Diet/exercise; Drug: Insulin NPH

Study type: Interventional

Funder types: Industry

Identifiers

NCT02131272

2015-1316 (Registry Identifier)

2013-005500-33 (EudraCT Number)

NN304-4093

U1111-1151-4056 (Other Identifier)

Details and patient eligibility

About

This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of insulin detemir versus insulin Neutral Protamine Hagedorn (NPH) 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 with or without other oral antidiabetic drug(s) with or without basal insulin.

Enrollment: 42 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Insulin detemir and diet/exercise

Experimental group

Description:

Current OADs i.e. metformin or other OADs are continued unchanged

Treatment:

Behavioral: Diet/exercise

Drug: Insulin NPH

Insulin NPH and diet/exercise

Active Comparator group

Description:

Current OADs i.e. metformin or other OADs are continued unchanged

Treatment:

Drug: Insulin detemir

Behavioral: Diet/exercise