Clinical trial NCT00856986: The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 987
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 subjects with type 2 diabetes. Subjects will continue their own pre-trial metformin treatment during the trial.


Eligibility 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 sulphonylurea

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
* Impaired 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

Primary outcomes:
measure: Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26.
timeFrame: Week 0 (Randomisation), week 26
Secondary outcomes:
measure: Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group)
timeFrame: Week 0, Week 52
measure: Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF)
timeFrame: Week 0, Week 52
measure: Mean Change From Randomisation in Fasting Plasma Glucose at Week 26
timeFrame: Week 0 (Randomisation), Week 26
measure: Mean Change From Randomisation in Fasting Plasma Glucose at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26
timeFrame: Week 0 (Randomisation), Week 26
measure: Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change From Randomisation in Fasting Insulin at Week 26
timeFrame: Week 0 (Randomisation), Week 26
measure: Mean Change From Randomisation in Fasting Insulin at Week 52
timeFrame: Week 0 (Randomisation), Week 52
measure: Mean Change From Randomisation in Fasting Pro-insulin at Week 26.
timeFrame: Week 0 (Randomisation), Week 26
measure: Mean Change From Randomisation in Fasting Pro-insulin at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change From Randomisation in Fasting C-peptide at Week 26.
timeFrame: Week 0 (Randomisation), Week 26
measure: Mean Change From Randomisation in Fasting C-peptide at Week 52.
timeFrame: Week 0, Week 52
measure: Mean Changes From Randomisation in Cholesterol Lipids at Week 26.
timeFrame: Week 0 (Randomisation), Week 26
measure: Mean Changes From Randomisation in Cholesterol Lipids at Week 52.
timeFrame: Week 0, Week 52
measure: Mean Change From Randomisation in Lipids: Triglycerides at Week 26
timeFrame: Week 0 (Randomisation), Week 26
measure: Mean Change From Randomisation in Lipids: Triglycerides at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26
timeFrame: Week 0 (Randomisation), Week 26
measure: Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change From Randomisation in Body Weight at Week 26
timeFrame: Week 0 (Randomisation), Week 26
measure: Mean Change From Randomisation in Body Weight at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change From Randomisation in Waist Circumference at Week 26.
timeFrame: Week 0 (Randomisation), Week 26
measure: Mean Change From Randomisation in Waist Circumference at Week 52.
timeFrame: Week 0, Week 52
measure: Mean Change From Randomisation in Hip Circumference at Week 26
timeFrame: Week 0 (Randomisation), Week 26
measure: Mean Change From Randomisation in Hip Circumference at Week 52
timeFrame: Week 0, week 52
measure: Mean Change From Randomisation in Waist to Hip Ratio at Week 26
timeFrame: Week 0 (Randomisation), Week 26
measure: Mean Change From Randomisation in Waist to Hip Ratio at Week 52
timeFrame: Week 0, Week 52
measure: Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26.
timeFrame: Week 0 (Randomisation), Week 26
measure: Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52.
timeFrame: Week 0, Week 52
measure: Adverse Events From Run-in (Week -12) to Week 52
timeFrame: Run-in (week -12) to Week 52
measure: Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26
timeFrame: weeks 0-26
measure: Hypoglycaemic Episodes Weeks 0-52
timeFrame: Week 0-52
Other outcomes:
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state: Texas
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state: Wisconsin
city: Bonheiden
country: Belgium
facility: Novo Nordisk Investigational Site
city: Leuven
country: Belgium
facility: Novo Nordisk Investigational Site
city: Edmonton
country: Canada
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state: Alberta
city: Winnipeg
country: Canada
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state: Manitoba
city: Halifax
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facility: Novo Nordisk Investigational Site
state: Nova Scotia
city: London
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state: Ontario
city: Mississauga
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Smiths Falls
country: Canada
facility: Novo Nordisk Investigational Site
state: Ontario
city: Ajax
country: Canada
facility: Novo Nordisk Investigational Site
city: Antibes
country: France
facility: Novo Nordisk Investigational Site
city: BRON cedex
country: France
facility: Novo Nordisk Investigational Site
city: CAHORS cedex 9
country: France
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city: Corbeil Essonnes
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city: Haguenau
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city: LA ROCHELLE cedex
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city: MARSEILLE cedex 08
country: France
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city: Marseille
country: France
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city: MONTPELLIER cedex 5
country: France
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city: Montpellier
country: France
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city: Narbonne
country: France
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city: Paris Cedex 10
country: France
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city: Paris
country: France
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city: PERPIGNAN cedex
country: France
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city: Pessac
country: France
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city: Poitiers
country: France
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city: Reims
country: France
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city: SAINT QUENTIN Cédex
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city: Saint-denis de La Reunion
country: France
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city: Saint-pierre de La Reunion
country: France
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city: Strasbourg
country: France
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city: Sète
country: France
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city: Tours
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city: Augsburg
country: Germany
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city: Bad Kreuznach
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city: Bad Mergentheim
country: Germany
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city: Bad Nauheim
country: Germany
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city: Berlin
country: Germany
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city: Berlin
country: Germany
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city: Berlin
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city: Bremen
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city: Dresden
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city: Dresden
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city: Duisburg
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city: Eisenach
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city: Erfurt
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city: Esslingen
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city: Frankfurt
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city: Hamburg
country: Germany
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country: Germany
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country: Germany
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country: Germany
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city: Sinsheim
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city: St. Ingbert
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city: Stuttgart
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city: Wangen
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city: Ancona
country: Italy
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city: Caserta
country: Italy
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country: Italy
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country: Italy
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country: Italy
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country: Italy
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city: Milano
country: Italy
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country: Netherlands
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country: Spain
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city: Xátiva
country: Spain
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city: Zaragoza
country: Spain
facility: Novo Nordisk Investigational Site
city: Aberdeen
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Ashton-Under-Lyne
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bath
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Belfast
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Belfast
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Belfast
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Blackburn
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bradford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bristol
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Coventry
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Derby
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Dundee
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Edgbaston, Birmingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Edinburgh
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Exeter
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Guildford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Hull
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Inverness
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Leicester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Liverpool
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Liverpool
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Londonderry
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Manchester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Manchester
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Northampton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Nuneaton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Oxford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Rugby
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Salford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Swansea
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Welwyn Garden City
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: DeVries JH, Bain SC, Rodbard HW, Seufert J, D'Alessio D, Thomsen AB, Zychma M, Rosenstock J; Liraglutide-Detemir Study Group. Sequential intensification of metformin treatment in type 2 diabetes with liraglutide followed by randomized addition of basal insulin prompted by A1C targets. Diabetes Care. 2012 Jul;35(7):1446-54. doi: 10.2337/dc11-1928. Epub 2012 May 14.
citation: Rosenstock J, Rodbard HW, Bain SC, D'Alessio D, Seufert J, Thomsen AB, Svendsen CB, DeVries JH; Liraglutide-Detemir Study Group. One-year sustained glycemic control and weight reduction in type 2 diabetes after addition of liraglutide to metformin followed by insulin detemir according to HbA1c target. J Diabetes Complications. 2013 Sep-Oct;27(5):492-500. doi: 10.1016/j.jdiacomp.2013.04.008. Epub 2013 Jun 6.
citation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.