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

Diabetes Mellitus, Type 2 Clinical Trial

— iDEAt2  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02131272
• Other study ID #: NN304-4093
• Secondary ID: 2013-005500-33U1
• Status: Terminated
• Phase: Phase 3
• Start date: June 11, 2014
• Est. completion date: June 14, 2016

Study information

• Verified date: August 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 insufficiently controlled on the maximum tolerated dose of metformin with or without other oral antidiabetic drug(s) with or without basal insulin.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: June 14, 2016
• Est. primary completion date: June 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
Argentina	Novo Nordisk Investigational Site	Caba
Brazil	Novo Nordisk Investigational Site	Aparecida de Goiania	Goias
Brazil	Novo Nordisk Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	Novo Nordisk Investigational Site	São Paulo	Sao Paulo
Brazil	Novo Nordisk Investigational Site	São Paulo	Sao Paulo
Croatia	Novo Nordisk Investigational Site	Zagreb
Egypt	Novo Nordisk Investigational Site	Alexandria
Egypt	Novo Nordisk Investigational Site	Cairo
Egypt	Novo Nordisk Investigational Site	Cairo
Germany	Novo Nordisk Investigational Site	Ludwigshafen
Germany	Novo Nordisk Investigational Site	Neuwied
Greece	Novo Nordisk Investigational Site	Goudi/ Athens
Greece	Novo Nordisk Investigational Site	Thessaloniki
Hungary	Novo Nordisk Investigational Site	Budapest
Hungary	Novo Nordisk Investigational Site	Budapest
Hungary	Novo Nordisk Investigational Site	Miskolc
India	Novo Nordisk Investigational Site	Ahmedabad	Gujarat
India	Novo Nordisk Investigational Site	Bangalore	Karnataka
India	Novo Nordisk Investigational Site	Bangalore	Karnataka
India	Novo Nordisk Investigational Site	Bangalore	Karnataka
India	Novo Nordisk Investigational Site	Chennai	Tamil Nadu
India	Novo Nordisk Investigational Site	Hyderabad	Andhra Pradesh
India	Novo Nordisk Investigational Site	Hyderabad	Andhra Pradesh
India	Novo Nordisk Investigational Site	Kolkata	West Bengal
Israel	Novo Nordisk Investigational Site	Beer Sheva
Israel	Novo Nordisk Investigational Site	Haifa
Italy	Novo Nordisk Investigational Site	Ancona
Italy	Novo Nordisk Investigational Site	Firenze
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Korea, Republic of	Novo Nordisk Investigational Site	Seoul
Lebanon	Novo Nordisk Investigational Site	Beirut
Lebanon	Novo Nordisk Investigational Site	Hazmieh
Lebanon	Novo Nordisk Investigational Site	Lebanon - Beirut
Malaysia	Novo Nordisk Investigational Site	Kota Kinabalu
Malaysia	Novo Nordisk Investigational Site	Kuala Lumpur
Malaysia	Novo Nordisk Investigational Site	Seremban
Malaysia	Novo Nordisk Investigational Site	Seri Manjung
Mexico	Novo Nordisk Investigational Site	Puebla
Morocco	Novo Nordisk Investigational Site	Casablanca
Morocco	Novo Nordisk Investigational Site	Fès
Morocco	Novo Nordisk Investigational Site	Marrakech
Morocco	Novo Nordisk Investigational Site	Rabat
Poland	Novo Nordisk Investigational Site	Wroclaw
Portugal	Novo Nordisk Investigational Site	Lisboa
Russian Federation	Novo Nordisk Investigational Site	Izhevsk
Russian Federation	Novo Nordisk Investigational Site	Stavropol
Russian Federation	Novo Nordisk Investigational Site	Tomsk
Serbia	Novo Nordisk Investigational Site	Nis
South Africa	Novo Nordisk Investigational Site	Lenasia	Gauteng
South Africa	Novo Nordisk Investigational Site	Observatory	Western Cape
South Africa	Novo Nordisk Investigational Site	Pretoria	Gauteng
Spain	Novo Nordisk Investigational Site	Esplugues Llobregat(Barcelona)
Taiwan	Novo Nordisk Investigational Site	Taichung
Taiwan	Novo Nordisk Investigational Site	Taoyuan
Turkey	Novo Nordisk Investigational Site	Adana
Turkey	Novo Nordisk Investigational Site	Ankara
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Kayseri
United States	Novo Nordisk Investigational Site	Amarillo	Texas
United States	Novo Nordisk Investigational Site	Atlanta	Georgia
United States	Novo Nordisk Investigational Site	Buffalo	New York
United States	Novo Nordisk Investigational Site	Cleveland	Ohio
United States	Novo Nordisk Investigational Site	Columbia	South Carolina
United States	Novo Nordisk Investigational Site	Edinburg	Texas
United States	Novo Nordisk Investigational Site	Hershey	Pennsylvania
United States	Novo Nordisk Investigational Site	Jacksonville	Florida
United States	Novo Nordisk Investigational Site	Jacksonville	Florida
United States	Novo Nordisk Investigational Site	Las Vegas	Nevada
United States	Novo Nordisk Investigational Site	Los Angeles	California
United States	Novo Nordisk Investigational Site	Memphis	Tennessee
United States	Novo Nordisk Investigational Site	Milwaukee	Wisconsin
United States	Novo Nordisk Investigational Site	Norfolk	Virginia
United States	Novo Nordisk Investigational Site	Pembroke Pines	Florida
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania
United States	Novo Nordisk Investigational Site	Providence	Rhode Island
United States	Novo Nordisk Investigational Site	Silver Spring	Maryland
United States	Novo Nordisk Investigational Site	Tallahassee	Florida
United States	Novo Nordisk Investigational Site	Toledo	Ohio
United States	Novo Nordisk Investigational Site	Tucson	Arizona
United States	Novo Nordisk Investigational Site	Washington	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Croatia,  Egypt,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Lebanon,  Malaysia,  Mexico,  Morocco,  Poland,  Portugal,  Russian Federation,  Serbia,  South Africa,  Spain,  Taiwan,  Turkey, 

References & Publications (1)

Wheeler MD, Barrientos-Perez M, Lo FS, Liang B, Lunsford A, Thórisdóttir Ó, 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 Jul 16. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (Glycosylated Haemoglobin)	Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26.	week 0, week 26
Secondary	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.	week 0, week 26
Secondary	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.	At week 26
Secondary	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.	At week 26
Secondary	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.	Weeks 0 - 26
Secondary	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.	Weeks 0 - 26
Secondary	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.	weeks 0 - 26

External Links

•   Clinical Trials at Novo Nordisk