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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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02131272
First Posted: May 6, 2014
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: Insulin detemir Drug: Insulin NPH Behavioral: Diet/exercise Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in HbA1c (Glycosylated Haemoglobin) [ Time Frame: week 0, week 26 ]
    Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 42
Actual Study Start Date: June 11, 2014
Study Completion Date: June 14, 2016
Primary Completion Date: June 14, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
Behavioral: Diet/exercise
Intervention will be performed through family based changes in eating and activity behaviours.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131272


  Show 82 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02131272     History of Changes
Other Study ID Numbers: NN304-4093
2013-005500-33 ( EudraCT Number )
U1111-1151-4056 ( Other Identifier: WHO )
2015-1316 ( Registry Identifier: REec )
First Submitted: May 2, 2014
First Posted: May 6, 2014
Results First Submitted: May 31, 2017
Results First Posted: September 1, 2017
Last Update Posted: September 1, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Metformin
Insulin Detemir
Hypoglycemic Agents
Isophane Insulin, Human
Insulin, Isophane
Physiological Effects of Drugs