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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

NCT02131272 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-09-10

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Insulin detemir

Administered subcutaneously (s.c., under the skin) once or twice daily. The subjects' pre-trial OAD's i.e. metformin treatment should continue unchanged during the treatment period.

DRUG

Insulin NPH

Administered subcutaneously (s.c., under the skin) once or twice daily. The subjects' pre-trial OADs i.e. metformin treatment should continue unchanged during the treatment period.

BEHAVIORAL

Diet/exercise

Intervention will be performed through family based changes in eating and activity behaviours.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-11
Primary Completion
2016-06-14
Completion
2016-06-14

Countries

  • United States
  • Argentina
  • Brazil
  • Croatia
  • Egypt
  • Germany
  • Greece
  • Hungary
  • India
  • Israel
  • Italy
  • Lebanon
  • Malaysia
  • Mexico
  • Morocco
  • Poland
  • Portugal
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02131272 on ClinicalTrials.gov