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 currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Novo Nordisk A/S
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02131272
First received: May 2, 2014
Last updated: August 15, 2014
Last verified: August 2014
  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 metformin and diet/exercise on glycaemic control 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.


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 Metformin and Diet/Exercise on Glycaemic Control in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on 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: August 2017
Estimated Primary Completion Date: August 2017 (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 a stable dose of metformin (1000-2000 mg/day) for at least 3 months prior to screening with or without other OAD(s) with or without basal insulin
  • 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
  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

Contacts
Contact: Novo Nordisk clinicaltrials@novonordisk.com

Locations
United States, Florida
Novo Nordisk Clinical Trial Call Center Recruiting
Tallahassee, Florida, United States, 32308
United States, Nevada
Novo Nordisk Clinical Trial Call Center Recruiting
Las Vegas, Nevada, United States, 89148
United States, Virginia
Novo Nordisk Clinical Trial Call Center Recruiting
Norfolk, Virginia, United States, 23507
Brazil
Recruiting
Sao Paulo, Brazil, 01406-100
Mexico
Recruiting
Puebla, Mexico, 72190
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

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
Study First Received: May 2, 2014
Last Updated: August 15, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency
Canada: Public Health Agency of Canada
China: Food and Drug Administration
Croatia: Ministry of Health and Social Care
Denmark: Danish Medicines Agency
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
India: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: National Institute of Health
Japan: Ministry of Health, Labor and Welfare
Macedonia, The Former Yugoslav Republic of: Ministry of Health
Malaysia: Ministry of Health
Mexico: National Institute of Public Health, Health Secretariat
Netherlands: Dutch Health Care Inspectorate
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Serbia: Agency for Drugs and Medicinal Devices
South Africa: Medicines Control Council
Spain: Ministry of Health
Taiwan: Department of Health
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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
Hypoglycemic Agents
Insulin, Isophane
Metformin
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014