DiabetesPhase 3iDEAt2NCT02131272
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
A Phase 3 study testing Insulin detemir, Insulin NPH and Diet/exercise in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 82 sites in 24 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- Insulin detemir, Insulin NPH and Diet/exercise
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 82 sitesin 24 countries
- Study dates
- 11 Jun 2014to 14 Jun 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
82 sites in 24 countries.
82 sites in 24 countries
United States23 sites
Novo Nordisk Investigational Site
Amarillo, Texas, 79106
Novo Nordisk Investigational Site
Atlanta, Georgia, 30322
Novo Nordisk Investigational Site
Buffalo, New York, 14203
Novo Nordisk Investigational Site
Cleveland, Ohio, 44195-0001
Novo Nordisk Investigational Site
Columbia, South Carolina, 29203
Novo Nordisk Investigational Site
Edinburg, Texas, 78539
Novo Nordisk Investigational Site
Hershey, Pennsylvania, 17033
Novo Nordisk Investigational Site
Jacksonville, Florida, 32207
Novo Nordisk Investigational Site
Jacksonville, Florida, 32256
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89148
Novo Nordisk Investigational Site
Los Angeles, California, 90027
Novo Nordisk Investigational Site
Memphis, Tennessee, 38119
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53226
Novo Nordisk Investigational Site
Norfolk, Virginia, 23507
Novo Nordisk Investigational Site
Pembroke Pines, Florida, 33026
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19104
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15224
Novo Nordisk Investigational Site
Providence, Rhode Island, 02903
Novo Nordisk Investigational Site
Reisterstown, Maryland, 20011
Novo Nordisk Investigational Site
Silver Spring, Maryland, 20910
Novo Nordisk Investigational Site
Tallahassee, Florida, 32308
Novo Nordisk Investigational Site
Toledo, Ohio, 43606
Novo Nordisk Investigational Site
Tucson, Arizona, 85724
India8 sites
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, 380007
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560002
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560034
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560045
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, 600 013
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500072
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500082
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700032
Turkey (Türkiye)5 sites
Novo Nordisk Investigational Site
Adana, 01130
Novo Nordisk Investigational Site
Ankara, 06100
Novo Nordisk Investigational Site
Istanbul, 34093
Novo Nordisk Investigational Site
Istanbul, 34890
Novo Nordisk Investigational Site
Kayseri, 38010
Brazil4 sites
Novo Nordisk Investigational Site
Aparecida de Goiânia, Goiás, 74935-530
Novo Nordisk Investigational Site
Porto Alegre, Rio Grande do Sul, 91350-250
Novo Nordisk Investigational Site
São Paulo, São Paulo, 01223-001
Novo Nordisk Investigational Site
São Paulo, São Paulo, 01228-000
Malaysia4 sites
Novo Nordisk Investigational Site
Kota Kinabalu, 88996
Novo Nordisk Investigational Site
Kuala Lumpur, 59100
Novo Nordisk Investigational Site
Seremban, 70300
Novo Nordisk Investigational Site
Seri Manjung, 32040
Morocco4 sites
Novo Nordisk Investigational Site
Casablanca, 20000
Novo Nordisk Investigational Site
Fes, 30000
Novo Nordisk Investigational Site
Marrakesh, 40000
Novo Nordisk Investigational Site
Rabat, 10000
Egypt3 sites
Novo Nordisk Investigational Site
Alexandria, 21131
Novo Nordisk Investigational Site
Cairo, 11562
Novo Nordisk Investigational Site
Cairo, 11628
Hungary3 sites
Novo Nordisk Investigational Site
Budapest, 1023
Novo Nordisk Investigational Site
Budapest, 1083
Novo Nordisk Investigational Site
Miskolc, 3501
Lebanon3 sites
Novo Nordisk Investigational Site
Beirut
Novo Nordisk Investigational Site
Hazmiyeh, 9615
Novo Nordisk Investigational Site
Lebanon - Beirut, 9611
Russia3 sites
Novo Nordisk Investigational Site
Izhevsk, 426009
Novo Nordisk Investigational Site
Stavropol, 355017
Novo Nordisk Investigational Site
Tomsk, 634034
South Africa3 sites
Novo Nordisk Investigational Site
Lenasia, Gauteng, 1827
Novo Nordisk Investigational Site
Observatory, Western Cape, 7925
Novo Nordisk Investigational Site
Pretoria, Gauteng, 0181
Germany2 sites
Novo Nordisk Investigational Site
Ludwigshafen, 67059
Novo Nordisk Investigational Site
Neuwied, 56564
Greece2 sites
Novo Nordisk Investigational Site
Goudi/ Athens, GR-11527
Novo Nordisk Investigational Site
Thessaloniki, GR 54642
Israel2 sites
Novo Nordisk Investigational Site
Beersheba, 84101
Novo Nordisk Investigational Site
Haifa, 31096
Italy2 sites
Novo Nordisk Investigational Site
Ancona, 60123
Novo Nordisk Investigational Site
Florence, 50139
South Korea2 sites
Novo Nordisk Investigational Site
Seoul, 05030
Novo Nordisk Investigational Site
Seoul, 135-720
Taiwan2 sites
Novo Nordisk Investigational Site
Taichung, 404
Novo Nordisk Investigational Site
Taoyuan, 333
Spain1 site
Novo Nordisk Investigational Site
Esplugues Llobregat(Barcelona), 08950
About this study
Official 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
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
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- Insulin detemir, Insulin NPH, Diet/exercise
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin detemirDrug
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.
Insulin NPHDrug
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.
Diet/exerciseBehavioural
Intervention will be performed through family based changes in eating and activity behaviours.
| Study group | Role | What they receive |
|---|---|---|
| Insulin detemir and diet/exercise | Experimental | Current OADs i.e. metformin or other OADs are continued unchanged Receives: Drug: Insulin NPH; Behavioral: Diet/exercise |
| Insulin NPH and diet/exercise | Active comparator | Current OADs i.e. metformin or other OADs are continued unchanged Receives: Drug: Insulin detemir; Behavioral: Diet/exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (Glycosylated Haemoglobin)
Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26.
Measured: week 0, week 26
Secondary outcomes (6)
Change in Body Weight Standard Deviation Score (SDS)
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.
Measured: 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.
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.
Measured: 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
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.
Measured: At week 26
Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
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.
Measured: Weeks 0 - 26
Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
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.
Measured: Weeks 0 - 26
Incidence of Adverse Events (AEs)
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.
Measured: weeks 0 - 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study start11 Jun 2014
- Primary completion14 Jun 2016
- Study completion14 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131272
- Sponsor's protocol ID
- NN304-4093
- Other IDs
- 2013-005500-33, U1111-1151-4056, 2015-1316
- Acronym
- iDEAt2
- Status last verified
- Aug 2018
- First submitted
- 2 May 2014
- Last updated
- 10 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wheeler MD, Barrientos-Perez M, Lo FS, Liang B, Lunsford A, Thorisdottir O, Zuckerman-Levin N. A 26-week, randomized trial of insulin detemir versus NPH insulin in children and adolescents with type 2 diabetes (iDEAt2). Eur J Pediatr. 2018 Oct;177(10):1497-1503. doi: 10.1007/s00431-018-3205-z. Epub 2018 Jul 16.
PubMed 30014302
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02131272
- Acronym / sponsor ID
- iDEAt2 / NN304-4093
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2014 (actual)
- Primary completion
- 14 Jun 2016 (actual)
- Study completion
- 14 Jun 2016 (actual)
- First posted
- 6 May 2014 (estimated)
- Results
- Posted 1 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin detemir and diet/exercise | Experimental | Drug: Insulin NPH, Behavioral: Diet/exerciseCurrent OADs i.e. metformin or other OADs are continued unchanged |
| Insulin NPH and diet/exercise | Active comparator | Drug: Insulin detemir, Behavioral: Diet/exerciseCurrent OADs i.e. metformin or other OADs are continued unchanged |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin detemirAdministered 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 and diet/exercise |
| Insulin NPHAdministered 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. | Drug | Insulin detemir and diet/exercise |
| Diet/exerciseIntervention will be performed through family based changes in eating and activity behaviours. | Behavioural | Insulin NPH and diet/exercise, Insulin detemir and diet/exercise |
Primary outcome
Change in HbA1c (Glycosylated Haemoglobin)
Time frame: week 0, week 26
Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26.
6 secondary outcomes
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
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
Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Time frame: Weeks 0 - 26
Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Time frame: Weeks 0 - 26
Incidence of Adverse Events (AEs)
Time frame: weeks 0 - 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30014302Wheeler MD, Barrientos-Perez M, Lo FS, Liang B, Lunsford A, Thorisdottir O, Zuckerman-Levin N. A 26-week, randomized trial of insulin detemir versus NPH insulin in children and adolescents with type 2 diabetes (iDEAt2). Eur J Pediatr. 2018 Oct;177(10):1497-1503. doi: 10.1007/s00431-018-3205-z. Epub 2018 Jul 16.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
82 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insulin detemir, Insulin NPH and Diet/exercise in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 82 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in United States, India, Turkey (Türkiye), Brazil, Malaysia and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (Glycosylated Haemoglobin) (time frame: week 0, week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02131272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.