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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

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 2

Intervention: insulin detemir (Drug); insulin NPH (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S

Overall contact:
Novo Nordisk, Email: clinicaltrials@novonordisk.com

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in HbA1c (glycosylated haemoglobin)

Secondary outcome:

Change in body weight standard deviation score (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 below 7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes 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

Total number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes

Incidence of adverse events (AEs)

Eligibility

Minimum age: 10 Years. Maximum age: 17 Years. Gender(s): Both.

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

Locations and Contacts

Novo Nordisk, Email: clinicaltrials@novonordisk.com

Caba C1425DUC, Argentina; Recruiting

Zagreb 10000, Croatia; Recruiting

Cairo, Egypt; Recruiting

Neuwied 56564, Germany; Recruiting

Goudi/ Athens GR-11527, Greece; Recruiting

Budapest 1083, Hungary; Recruiting

Haifa 31096, Israel; Recruiting

Firenze 50139, Italy; Recruiting

Seoul 143-729, Korea, Republic of; Recruiting

Beirut, Lebanon; Recruiting

Kota Bharu, Kelantan 16150, Malaysia; Recruiting

Puebla 72190, Mexico; Recruiting

Casablanca 20000, Morocco; Recruiting

Wroclaw 50-311, Poland; Recruiting

Lisboa 1250-230, Portugal; Recruiting

Tomsk 634034, Russian Federation; Recruiting

Nis 18 000, Serbia; Recruiting

Esplugues Llobregat 08950, Spain; Recruiting

Taichung 404, Taiwan; Recruiting

Istanbul 34093, Turkey; Recruiting

Novo Nordisk Clinical Trial Call Center, Tucson, Arizona 85724, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Los Angeles, California 90027, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Washington, District of Columbia 20020, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Jacksonville, Florida 32207-8426, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Pembroke Pines, Florida 33026, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Tallahassee, Florida 32308, United States; Recruiting

Lenasia, Gauteng 1827, South Africa; Recruiting

Novo Nordisk Clinical Trial Call Center, Atlanta, Georgia 30322, United States; Recruiting

Ahmedabad, Gujarat 380007, India; Recruiting

Novo Nordisk Clinical Trial Call Center, Silver Spring, Maryland 20910, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Las Vegas, Nevada 89128, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Buffalo, New York 14222, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Sleepy Hollow, New York 10591, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Cleveland, Ohio 44195-0001, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Hershey, Pennsylvania 17033, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Philadelphia, Pennsylvania 19104, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Pittsburgh, Pennsylvania 15224, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Providence, Rhode Island 02903, United States; Recruiting

São Paulo, Sao Paulo 01228-000, Brazil; Recruiting

Novo Nordisk Clinical Trial Call Center, Columbia, South Carolina 29203, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Memphis, Tennessee 38119, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Amarillo, Texas 79106, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Edinburg, Texas 78539, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Norfolk, Virginia 23507, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Milwaukee, Wisconsin 53226, United States; Recruiting

Additional Information

Clinical Trials at Novo Nordisk

Starting date: June 2014
Last updated: July 31, 2015

Page last updated: August 23, 2015

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