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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02131272
First received: May 2, 2014
Last updated: December 30, 2015
Last verified: December 2015
  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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in body weight standard deviation score (SDS) [ Time Frame: Week 0, Week 26 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Total number of treatment emergent nocturnal (23:00-06:59) severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes [ Time Frame: Weeks 0 - 26 ] [ Designated as safety issue: No ]
  • Total number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes [ Time Frame: Weeks 0 - 26 ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) [ Time Frame: Weeks 0 - 26 ] [ Designated as safety issue: No ]

Estimated Enrollment: 358
Study Start Date: June 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin detemir + metformin + diet/exercise Drug: insulin detemir
Administered subcutaneously (s.c., under the skin) once or twice daily. The subjects' pre-trial metformin treatment should continue unchanged during the treatment period.
Active Comparator: Insulin NPH + metformin + diet/exercise Drug: insulin NPH
Administered subcutaneously (s.c., under the skin) once or twice daily. The subjects' pre-trial metformin treatment should continue unchanged during the treatment period.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02131272

  Show 19 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  U1111-1151-4056  2015-1316 
Study First Received: May 2, 2014
Last Updated: December 30, 2015
Health Authority: Brazil: National Health Surveillance Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Malaysia: Ministry of Health
Mexico: National Institute of Public Health, Health Secretariat
Russia: Pharmacological Committee, Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Turkey: Ministry of Health
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 27, 2016