The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00856986

Purpose

This trial is conducted in Europe and North America. The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus liraglutide and metformin in people with type 2 diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: liraglutide Drug: insulin detemir (Levemir®) Drug: metformin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes. A 26 Week, Randomised, Open-label, Parallel-group, Multicentre, Multinational Trial With a 26 Week Extension

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin Detemir Liraglutide Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Change in HbA1c from baseline [ Time Frame: at 26 weeks (using last observation carried forward) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fasting plasma glucose (central laboratory) [ Time Frame: at 26 weeks ] [ Designated as safety issue: No ]
Fasting plasma glucose (central laboratory) [ Time Frame: at 52 weeks ] [ Designated as safety issue: No ]
7-point plasma glucose profile (self-measured) [ Time Frame: at 26 weeks ] [ Designated as safety issue: No ]
7-point plasma glucose profile (self-measured) [ Time Frame: at 52 weeks ] [ Designated as safety issue: No ]
Fasting insulin [ Time Frame: at 26 weeks ] [ Designated as safety issue: No ]
Fasting insulin [ Time Frame: at 52 weeks ] [ Designated as safety issue: No ]
Fasting proinsulin [ Time Frame: at 26 weeks ] [ Designated as safety issue: No ]
Fasting proinsulin [ Time Frame: at 52 weeks ] [ Designated as safety issue: No ]
Fasting C-peptide [ Time Frame: at 26 weeks ] [ Designated as safety issue: No ]
Fasting C-peptide [ Time Frame: at 52 weeks ] [ Designated as safety issue: No ]
Lipids [ Time Frame: at 26 weeks ] [ Designated as safety issue: No ]
Lipids [ Time Frame: at 52 weeks ] [ Designated as safety issue: No ]
Body weight [ Time Frame: at 26 weeks ] [ Designated as safety issue: No ]
Body weight [ Time Frame: at 52 weeks ] [ Designated as safety issue: No ]
Waist and hip circumference [ Time Frame: at 26 weeks ] [ Designated as safety issue: No ]
Waist and hip circumference [ Time Frame: at 52 weeks ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: at 26 weeks ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: at 52 weeks ] [ Designated as safety issue: Yes ]
Hypoglycaemic events [ Time Frame: at 26 weeks ] [ Designated as safety issue: Yes ]
Hypoglycaemic events [ Time Frame: at 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	940
Study Start Date:	March 2009
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: liraglutide 1.8 mg/day for s.c. injection. Randomised treatment arm of insulin detemir in combination with liraglutide and metformin for subjects with HbA1c equal to or greater than 7.0% Drug: insulin detemir (Levemir®) For s.c. injection once daily. Dose will be titrated based on fasting self-measured plasma glucose levels according to a pre-specified algorhitm. Randomised treatment arm of insulin detemir in combination with liraglutide and metformin for subjects with HbA1c equal to or greater than 7.0% Drug: metformin Tablets, at least 1500 mg/day. Randomised treatment arm of insulin detemir in combination with liraglutide and metformin for subjects with HbA1c equal to or greater than 7.0%
B: Experimental	Drug: liraglutide 1.8 mg/day for s.c. injection. Randomised treatment arm with subjects continuing liraglutide and metformin treatment without intensification with insulin detemir despite HbA1c equal to or greater than 7.0% Drug: metformin Tablets, at least 1500 mg/day. Randomised treatment arm with subjects continuing liraglutide and metformin treatment without intensification with insulin detemir despite HbA1c equal to or greater than 7.0%
C: Experimental	Drug: liraglutide 1.8 mg/day for s.c. injection. Non-randomised trial arm with subjects continuing liraglutide and metformin treatment without intensification with insulin detemir. Subjects with HbA1c less than 7.0% after 12 weeks of run-in will continue in the trial in this arm Drug: metformin Tablets, at least 1500 mg/day. Non-randomised treatment arm with subjects continuing liraglutide and metformin treatment without intensification with insulin detemir. Subjects with HbA1c less than 7.0% after 12 weeks of run-in will continue in the trial in this arm

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects diagnosed with type 2 diabetes, insulin naïve and treated with metformin as monotherapy for at least 3 months prior to screening, at a stable dose of at least 1500 mg/day or metformin (at least 1500 mg/day) and a sulfonylurea (less than or equal to half of the maximum approved dose), both at a stable dose for at least 3 months prior to screening. Previous short-term insulin treatment in connection with intercurrent illness is allowed at the discretion of the Investigator
HbA1c 7.0-10.0% (both inclusive) for subjects on metformin monotherapy
HbA1c 7.0-8.5% (both inclusive) for subjects on metformin in combination with a sulfonylurea

Exclusion Criteria:

Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the Investigator)
Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 3 months prior to screening
Recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator
Impaired kidney function
Impared liver function
Uncontrolled treated/untreated hypertension
Cancer or any clinically significant disease or disorder as judged by the Investigator
Previous participation in the run-in phase of this trial. Re-screening is allowed once
History of chronic pancreatitis or idiopathic pancreatitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856986

Contacts

Contact: Novo Nordisk Clinical Trial Call Center

866-867-7178

Show 74 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Anne B. Thomsen, MD, PhD

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 A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN2211-1842, EudraCT No: 2007-005317-19
Study First Received:	March 5, 2009
Last Updated:	July 28, 2009
ClinicalTrials.gov Identifier:	NCT00856986 History of Changes
Health Authority:	Belgium: Federal Agency for Medicines and Health Products; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Netherlands: Medicines Evaluation Board, Dutch Health Care Inspectorate; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Metformin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on September 10, 2009