NCT02131272|TerminatedPhase 3ResultsDMC

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

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

Novo Nordisk A/S ClinicalTrials.gov

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4 other identifiers

NN304-40932013-005500-33U1111-1151-40562015-1316

Study Type

interventional

Target

Locations

24 countries

Sites

Timeline

RegisteredMay 2014

StartedJun 2014

CompletionJun 2016

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3 diabetes

Timeline

Completed

Started Jun 2014

Typical duration for phase_3 diabetes

Geographic Reach

24 countries

82 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

May 2, 2014

Completed

4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed

1 month until next milestone

Study Start

First participant enrolled

June 11, 2014

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2016

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

September 1, 2017

Completed

Last Updated

September 10, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

May 2, 2014

Results QC Date

May 31, 2017

Last Update Submit

August 9, 2018

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c (Glycosylated Haemoglobin)
Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26.
week 0, week 26

Secondary Outcomes (6)

Change in Body Weight Standard Deviation Score (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.
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
At week 26
Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Weeks 0 - 26
Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Weeks 0 - 26
+1 more secondary outcomes

Study Arms (2)

Insulin detemir and diet/exercise

EXPERIMENTAL

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

Drug: Insulin NPHBehavioral: Diet/exercise

Insulin NPH and diet/exercise

ACTIVE COMPARATOR

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

Drug: Insulin detemirBehavioral: Diet/exercise

Interventions

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 NPH and diet/exercise

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.

Insulin detemir and diet/exercise

Diet/exerciseBEHAVIORAL

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

Insulin NPH and diet/exerciseInsulin detemir and diet/exercise

Eligibility Criteria

Age10 Years - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.