Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes - Full Text View

Purpose

This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.

Condition	Intervention	Phase
Diabetes Diabetes Mellitus, Type 2	Drug: liraglutide Drug: placebo Drug: metformin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Metformin Metformin hydrochloride Liraglutide

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Change in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of subjects having HbA1c below 7.0% [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Number of subjects having HbA1c below 7.0% [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Number of subjects having HbA1c maximum 6.5% [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Number of subjects having HbA1c maximum 6.5% [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Number of subjects having HbA1c below 7.0% without severe or minor hypoglycaemic episodes [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Number of subjects having HbA1c below 7.0% without severe or minor hypoglycaemic episodes [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]
Change from baseline in 7-point self-measured plasma glucose [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Change from baseline in 7-point self-measured plasma glucose [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]
Change from baseline in body weight [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Change from baseline in body weight [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]
Change from baseline in BMI standard deviation score (SDS) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
Change from baseline in BMI standard deviation score (SDS) [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]
Number of adverse events (AEs) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Number of adverse events (AEs) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Number of adverse events (AEs) [ Time Frame: week 104 (1 year follow-up) ] [ Designated as safety issue: No ]
Number of adverse events (AEs) [ Time Frame: Week 156 (2 year follow-up) ] [ Designated as safety issue: No ]
Number of serious adverse events (SAEs) [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Number of serious adverse events (SAEs) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Number of serious adverse events (SAEs) [ Time Frame: Week 104 (1 year follow-up) ] [ Designated as safety issue: No ]
Number of serious adverse events (SAEs) [ Time Frame: Week 156 (2 year follow-up ) ] [ Designated as safety issue: No ]
Growth velocity [ Time Frame: Week 104 (1 year follow-up) ] [ Designated as safety issue: No ]
Growth velocity [ Time Frame: Week 156 (2 year follow-up) ] [ Designated as safety issue: No ]
Pubertal progression [ Time Frame: Week 104 (1 year follow-up) ] [ Designated as safety issue: No ]
Pubertal progression [ Time Frame: Week 156 (2 year follow-up) ] [ Designated as safety issue: No ]

Estimated Enrollment:	172
Study Start Date:	November 2012
Estimated Study Completion Date:	November 2017
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lira + Met	Drug: liraglutide Administered subcutaneously (s.c., under the skin) once daily.1.8 mg or maximum tolerated dose (MTD: 0.6 mg, 1.2 mg, 1.8 mg) for 26 weeks. Subjects will continue treatment in a 26 week open-labelled extension.. If subjects treated with liraglutide and metformin meet withdrawal criteria during the open-label period, subjects on liraglutide 0.6 or 1.2 mg will be able to increase the liraglutide to a maximum dose of 1.8 mg. Drug: metformin Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.
Placebo Comparator: Placebo + Met	Drug: placebo Administered subcutaneously (s.c., under the skin) once daily for 26 weeks. Subjects will discontinue placebo treatment in the open-labelled extension. Rescue treatment will be allowed if needed in the 26 week open-labelled extension. Drug: metformin Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.

Arms

Assigned Interventions

Experimental: Lira + Met

Drug: liraglutide

Administered subcutaneously (s.c., under the skin) once daily.1.8 mg or maximum tolerated dose (MTD: 0.6 mg, 1.2 mg, 1.8 mg) for 26 weeks. Subjects will continue treatment in a 26 week open-labelled extension.. If subjects treated with liraglutide and metformin meet withdrawal criteria during the open-label period, subjects on liraglutide 0.6 or 1.2 mg will be able to increase the liraglutide to a maximum dose of 1.8 mg.

Drug: metformin

Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.

Placebo Comparator: Placebo + Met

Drug: placebo

Administered subcutaneously (s.c., under the skin) once daily for 26 weeks. Subjects will discontinue placebo treatment in the open-labelled extension. Rescue treatment will be allowed if needed in the 26 week open-labelled extension.

Drug: metformin

Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.

Eligibility

Ages Eligible for Study:	10 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children and adolescents between the ages of 10-16 years. Subjects cannot turn 17 and 11 months before the end of treatment (52 weeks)
Diagnosis of type 2 diabetes mellitus and treated for at least 90 days with diet and exercise alone, or diet and exercise in combination with metformin monotherapy.
HbA1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin
Body mass index (BMI) above 85% percentile of the general age and gender matched population

Exclusion Criteria:

Type 1 diabetes
Maturity onset diabetes of the young (MODY)
Use of any antidiabetic agent other than metformin within 90 days prior to screening. Short term treatment with insulin is allowed
Recurrent severe or major hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
History of chronic pancreatitis or idiopathic acute pancreatitis
Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial
Uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children
Known or suspected abuse of alcohol or drugs/narcotics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541215

Contacts

Contact: Novo Nordisk

clinicaltrials@novonordisk.com

Show 62 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:	Carsten Vendelbo Jensen	Novo Nordisk
Study Director:	Tamara Marotte-Hurbon	Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT01541215 History of Changes
Other Study ID Numbers:	NN2211-3659, 2011-002605-29, P/288/2010, U1111-1121-8743
Study First Received:	February 23, 2012
Last Updated:	May 17, 2013
Health Authority:	Belgium: Federal Agency for Medicines and Healthcare Products Brazil: Ministry of Health Canada: Public Health Agency of Canada Croatia: Ministry of Health and Social Care Denmark: Danish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Greece: Ministry of Health Hungary: National Institute of Pharmacy India: Ministry of Health and Family Wellfare Israel: Israeli Health Ministry Pharmaceutical Administration Italy: Ministry of Health Macedonia, The Former Yugoslav Republic of: Ministry of Health Mexico: National Institute of Public Health, Health Secretariat Norway: Norwegian Medicines Control Authority Russia: Federal Service for Control of Health Care and Social Development Serbia: Agency for Drugs and Medicinal Devices Spain: Spanish Agency of Medicines and Health Care Products Sweden: Medical Products Agency Turkey: Ministry of Health Drug and Pharmaceutical Department United Kingdom: Medicines and Healthcare Products Regulatory United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Glucagon-Like Peptide 1

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 19, 2013

Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes (Ellipse™)