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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 (iDEAt2)

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Insulin detemir
Insulin NPH
Diet/exercise
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin detemir and diet/exercise

Insulin NPH and diet/exercise

Arm Description

Current OADs i.e. metformin or other OADs are continued unchanged

Current OADs i.e. metformin or other OADs are continued unchanged

Outcomes

Primary Outcome Measures

Change in HbA1c (Glycosylated Haemoglobin)
Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 2, 2014
Last Updated
August 9, 2018
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02131272
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Study Start Date
June 11, 2014 (Actual)
Primary Completion Date
June 14, 2016 (Actual)
Study Completion Date
June 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin detemir and diet/exercise
Arm Type
Experimental
Arm Description
Current OADs i.e. metformin or other OADs are continued unchanged
Arm Title
Insulin NPH and diet/exercise
Arm Type
Active Comparator
Arm Description
Current OADs i.e. metformin or other OADs are continued unchanged
Intervention Type
Drug
Intervention Name(s)
Insulin detemir
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Insulin NPH
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diet/exercise
Intervention Description
Intervention will be performed through family based changes in eating and activity behaviours.
Primary Outcome Measure Information:
Title
Change in HbA1c (Glycosylated Haemoglobin)
Description
Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26.
Time Frame
week 0, week 26
Secondary Outcome Measure Information:
Title
Change in Body Weight Standard Deviation Score (SDS)
Description
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.
Time Frame
week 0, week 26
Title
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.
Description
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.
Time Frame
At week 26
Title
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
Description
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.
Time Frame
At week 26
Title
Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Description
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.
Time Frame
Weeks 0 - 26
Title
Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Description
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.
Time Frame
Weeks 0 - 26
Title
Incidence of Adverse Events (AEs)
Description
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.
Time Frame
weeks 0 - 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Washington
State/Province
Maryland
ZIP/Postal Code
20011
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-0001
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Caba
ZIP/Postal Code
C1425DUC
Country
Argentina
Facility Name
Novo Nordisk Investigational Site
City
Aparecida de Goiania
State/Province
Goias
ZIP/Postal Code
74935-530
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-250
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01223-001
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Novo Nordisk Investigational Site
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Facility Name
Novo Nordisk Investigational Site
City
Cairo
ZIP/Postal Code
11628
Country
Egypt
Facility Name
Novo Nordisk Investigational Site
City
Ludwigshafen
ZIP/Postal Code
67059
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Neuwied
ZIP/Postal Code
56564
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Goudi/ Athens
ZIP/Postal Code
GR-11527
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Thessaloniki
ZIP/Postal Code
GR 54642
Country
Greece
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Miskolc
ZIP/Postal Code
3501
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500072
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500082
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380007
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560045
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 013
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700032
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Ancona
ZIP/Postal Code
60123
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Novo Nordisk Investigational Site
City
Beirut
Country
Lebanon
Facility Name
Novo Nordisk Investigational Site
City
Hazmieh
ZIP/Postal Code
9615
Country
Lebanon
Facility Name
Novo Nordisk Investigational Site
City
Lebanon - Beirut
ZIP/Postal Code
9611
Country
Lebanon
Facility Name
Novo Nordisk Investigational Site
City
Kota Kinabalu
ZIP/Postal Code
88996
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Seremban
ZIP/Postal Code
70300
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Seri Manjung
ZIP/Postal Code
32040
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Puebla
ZIP/Postal Code
72190
Country
Mexico
Facility Name
Novo Nordisk Investigational Site
City
Casablanca
ZIP/Postal Code
20000
Country
Morocco
Facility Name
Novo Nordisk Investigational Site
City
Fès
ZIP/Postal Code
30000
Country
Morocco
Facility Name
Novo Nordisk Investigational Site
City
Marrakech
ZIP/Postal Code
40000
Country
Morocco
Facility Name
Novo Nordisk Investigational Site
City
Rabat
ZIP/Postal Code
10000
Country
Morocco
Facility Name
Novo Nordisk Investigational Site
City
Wroclaw
ZIP/Postal Code
50-311
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Lisboa
ZIP/Postal Code
1250-230
Country
Portugal
Facility Name
Novo Nordisk Investigational Site
City
Izhevsk
ZIP/Postal Code
426009
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Tomsk
ZIP/Postal Code
634034
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Nis
ZIP/Postal Code
18 000
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Lenasia
State/Province
Gauteng
ZIP/Postal Code
1827
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Observatory
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Esplugues Llobregat(Barcelona)
ZIP/Postal Code
08950
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Adana
ZIP/Postal Code
01130
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Kayseri
ZIP/Postal Code
38010
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
30014302
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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