A trial investigating 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 ± other oral antidiabetic drug(s) ± basal insuli

Phase 1

• Conditions: Diabetes Mellitus, Type 2; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]; MedDRA version: 18.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861

• Registration Number: EUCTR2013-005500-33-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-19
• Last Update Posted: 12 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

1. 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
2. Male or female, 10 years = age =17 years at the time of signing informed consent/assent
3. Diagnosis of type 2 diabetes mellitus at least 3 months prior to screening
4. Treated with the maximum tolerated stable dose of metformin for at least 3 months prior to screening or have documented complete metformin intolerance. Note other OADs and basal insulin are allowed; bolus insulin is only allowed as rescue treatment for a maximum of 7 days for the last 3 months prior to screening.
5. HbA1c; = 7.0% and = 10.5% (= 53 mmol/mol and = 91 mmol/mol) at screening
Are the trial subjects under 18? yes
Number of subjects for this age range: 358
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Maturity onset diabetes of the young (MODY)
2. Fasting C-peptide at screening <0.6 ng/mL
3. Impaired liver function defined as alanine aminotransferase (ALT) = 2.5 times upper normal limit
4. Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator
5. Treatmen with any medication for the indication of diabetes or obesity other than stated in the exclusion criteria in a period of 3 months before the day of screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified