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)

August 9, 2018 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Caba, Argentina, C1425DUC
        • Novo Nordisk Investigational Site
  • Brazil
    • Goias
      • Aparecida de Goiania, Goias, Brazil, 74935-530
        • Novo Nordisk Investigational Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-250
        • Novo Nordisk Investigational Site
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 01223-001
        • Novo Nordisk Investigational Site
      • São Paulo, Sao Paulo, Brazil, 01228-000
        • Novo Nordisk Investigational Site
  • Croatia
      • Zagreb, Croatia, 10000
        • Novo Nordisk Investigational Site
  • Egypt
      • Alexandria, Egypt, 21131
        • Novo Nordisk Investigational Site
      • Cairo, Egypt, 11562
        • Novo Nordisk Investigational Site
      • Cairo, Egypt, 11628
        • Novo Nordisk Investigational Site
  • Germany
      • Ludwigshafen, Germany, 67059
        • Novo Nordisk Investigational Site
      • Neuwied, Germany, 56564
        • Novo Nordisk Investigational Site
  • Greece
      • Goudi/ Athens, Greece, GR-11527
        • Novo Nordisk Investigational Site
      • Thessaloniki, Greece, GR 54642
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1083
        • Novo Nordisk Investigational Site
      • Budapest, Hungary, 1023
        • Novo Nordisk Investigational Site
      • Miskolc, Hungary, 3501
        • Novo Nordisk Investigational Site
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500072
        • Novo Nordisk Investigational Site
      • Hyderabad, Andhra Pradesh, India, 500082
        • Novo Nordisk Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380007
        • Novo Nordisk Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560034
        • Novo Nordisk Investigational Site
      • Bangalore, Karnataka, India, 560002
        • Novo Nordisk Investigational Site
      • Bangalore, Karnataka, India, 560045
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 013
        • Novo Nordisk Investigational Site
    • West Bengal
      • Kolkata, West Bengal, India, 700032
        • Novo Nordisk Investigational Site
  • Israel
      • Beer Sheva, Israel, 84101
        • Novo Nordisk Investigational Site
      • Haifa, Israel, 31096
        • Novo Nordisk Investigational Site
  • Italy
      • Ancona, Italy, 60123
        • Novo Nordisk Investigational Site
      • Firenze, Italy, 50139
        • Novo Nordisk Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 05030
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 135-720
        • Novo Nordisk Investigational Site
  • Lebanon
      • Beirut, Lebanon
        • Novo Nordisk Investigational Site
      • Hazmieh, Lebanon, 9615
        • Novo Nordisk Investigational Site
      • Lebanon - Beirut, Lebanon, 9611
        • Novo Nordisk Investigational Site
  • Malaysia
      • Kota Kinabalu, Malaysia, 88996
        • Novo Nordisk Investigational Site
      • Kuala Lumpur, Malaysia, 59100
        • Novo Nordisk Investigational Site
      • Seremban, Malaysia, 70300
        • Novo Nordisk Investigational Site
      • Seri Manjung, Malaysia, 32040
        • Novo Nordisk Investigational Site
  • Mexico
      • Puebla, Mexico, 72190
        • Novo Nordisk Investigational Site
  • Morocco
      • Casablanca, Morocco, 20000
        • Novo Nordisk Investigational Site
      • Fès, Morocco, 30000
        • Novo Nordisk Investigational Site
      • Marrakech, Morocco, 40000
        • Novo Nordisk Investigational Site
      • Rabat, Morocco, 10000
        • Novo Nordisk Investigational Site
  • Poland
      • Wroclaw, Poland, 50-311
        • Novo Nordisk Investigational Site
  • Portugal
      • Lisboa, Portugal, 1250-230
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Izhevsk, Russian Federation, 426009
        • Novo Nordisk Investigational Site
      • Stavropol, Russian Federation, 355017
        • Novo Nordisk Investigational Site
      • Tomsk, Russian Federation, 634034
        • Novo Nordisk Investigational Site
  • Serbia
      • Nis, Serbia, 18 000
        • Novo Nordisk Investigational Site
  • South Africa
    • Gauteng
      • Lenasia, Gauteng, South Africa, 1827
        • Novo Nordisk Investigational Site
      • Pretoria, Gauteng, South Africa, 0181
        • Novo Nordisk Investigational Site
    • Western Cape
      • Observatory, Western Cape, South Africa, 7925
        • Novo Nordisk Investigational Site
  • Spain
      • Esplugues Llobregat(Barcelona), Spain, 08950
        • Novo Nordisk Investigational Site
  • Taiwan
      • Taichung, Taiwan, 404
        • Novo Nordisk Investigational Site
      • Taoyuan, Taiwan, 333
        • Novo Nordisk Investigational Site
  • Turkey
      • Adana, Turkey, 01130
        • Novo Nordisk Investigational Site
      • Ankara, Turkey, 06100
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34890
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34093
        • Novo Nordisk Investigational Site
      • Kayseri, Turkey, 38010
        • Novo Nordisk Investigational Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Novo Nordisk Investigational Site
    • California
      • Los Angeles, California, United States, 90027
        • Novo Nordisk Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Novo Nordisk Investigational Site
      • Jacksonville, Florida, United States, 32256
        • Novo Nordisk Investigational Site
      • Pembroke Pines, Florida, United States, 33026
        • Novo Nordisk Investigational Site
      • Tallahassee, Florida, United States, 32308
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Novo Nordisk Investigational Site
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • Novo Nordisk Investigational Site
      • Washington, Maryland, United States, 20011
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Novo Nordisk Investigational Site
    • New York
      • Buffalo, New York, United States, 14203
        • Novo Nordisk Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195-0001
        • Novo Nordisk Investigational Site
      • Toledo, Ohio, United States, 43606
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Novo Nordisk Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15224
        • Novo Nordisk Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Novo Nordisk Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Novo Nordisk Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Novo Nordisk Investigational Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Novo Nordisk Investigational Site
      • Edinburg, Texas, United States, 78539
        • Novo Nordisk Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin detemir and diet/exercise
Current OADs i.e. metformin or other OADs are continued unchanged
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.
Active Comparator: Insulin NPH and diet/exercise
Current OADs i.e. metformin or other OADs are continued unchanged
Behavioral: Diet/exercise
Intervention will be performed through family based changes in eating and activity behaviours.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c (Glycosylated Haemoglobin)
Time Frame: week 0, week 26
Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26.
week 0, week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Weight Standard Deviation Score (SDS)
Time Frame: week 0, week 26
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.
Time Frame: At week 26
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
Time Frame: At week 26
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
Time Frame: Weeks 0 - 26
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
Time Frame: Weeks 0 - 26
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)
Time Frame: weeks 0 - 26
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2014

Primary Completion (Actual)

June 14, 2016

Study Completion (Actual)

June 14, 2016

Study Registration Dates

First Submitted

May 2, 2014

First Submitted That Met QC Criteria

May 2, 2014

First Posted (Estimate)

May 6, 2014

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN304-4093
  • 2013-005500-33 (EudraCT Number)
  • U1111-1151-4056 (Other Identifier: WHO)
  • 2015-1316 (Registry Identifier: REec)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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