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

January 25, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

987

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Bonheiden, Belgium, 2820
    - Novo Nordisk Investigational Site
  - Leuven, Belgium, 3000
    - Novo Nordisk Investigational Site
Canada
- - Ajax, Canada, L1S 7K8
    - Novo Nordisk Investigational Site
- Alberta
  - Edmonton, Alberta, Canada, T5J 3N4
    - Novo Nordisk Investigational Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 3P4
    - Novo Nordisk Investigational Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - Novo Nordisk Investigational Site
- Ontario
  - London, Ontario, Canada, N6G 2M1
    - Novo Nordisk Investigational Site
  - Mississauga, Ontario, Canada, L5M 2V8
    - Novo Nordisk Investigational Site
  - Smiths Falls, Ontario, Canada, K7A 4W8
    - Novo Nordisk Investigational Site
France
- - Antibes, France, 06600
    - Novo Nordisk Investigational Site
  - BRON cedex, France, 69677
    - Novo Nordisk Investigational Site
  - CAHORS cedex 9, France, 46005
    - Novo Nordisk Investigational Site
  - Corbeil Essonnes, France, 91106
    - Novo Nordisk Investigational Site
  - Haguenau, France, 67504
    - Novo Nordisk Investigational Site
  - LA ROCHELLE cedex, France, 17019
    - Novo Nordisk Investigational Site
  - Le Creusot, France, 71200
    - Novo Nordisk Investigational Site
  - MARSEILLE cedex 08, France, 13285
    - Novo Nordisk Investigational Site
  - MONTPELLIER cedex 5, France, 34295
    - Novo Nordisk Investigational Site
  - Marseille, France, 13008
    - Novo Nordisk Investigational Site
  - Montpellier, France, 34070
    - Novo Nordisk Investigational Site
  - Narbonne, France, 11108
    - Novo Nordisk Investigational Site
  - PERPIGNAN cedex, France, 66046
    - Novo Nordisk Investigational Site
  - Paris, France, 75181
    - Novo Nordisk Investigational Site
  - Paris Cedex 10, France, 75475
    - Novo Nordisk Investigational Site
  - Pessac, France, 33600
    - Novo Nordisk Investigational Site
  - Poitiers, France, 86000
    - Novo Nordisk Investigational Site
  - Reims, France, 51056
    - Novo Nordisk Investigational Site
  - SAINT QUENTIN Cédex, France, 02321
    - Novo Nordisk Investigational Site
  - Saint-denis de La Reunion, France, 97405
    - Novo Nordisk Investigational Site
  - Saint-pierre de La Reunion, France, 97448
    - Novo Nordisk Investigational Site
  - Strasbourg, France, 67000
    - Novo Nordisk Investigational Site
  - Sète, France, 34200
    - Novo Nordisk Investigational Site
  - Tours, France, 37044
    - Novo Nordisk Investigational Site
Germany
- - Augsburg, Germany, 86150
    - Novo Nordisk Investigational Site
  - Bad Kreuznach, Germany, 55545
    - Novo Nordisk Investigational Site
  - Bad Mergentheim, Germany, 97980
    - Novo Nordisk Investigational Site
  - Bad Nauheim, Germany, 61231
    - Novo Nordisk Investigational Site
  - Berlin, Germany, 12163
    - Novo Nordisk Investigational Site
  - Berlin, Germany, 10789
    - Novo Nordisk Investigational Site
  - Berlin, Germany, 13055
    - Novo Nordisk Investigational Site
  - Bremen, Germany, 28213
    - Novo Nordisk Investigational Site
  - Dresden, Germany, 01219
    - Novo Nordisk Investigational Site
  - Dresden, Germany, 01307
    - Novo Nordisk Investigational Site
  - Duisburg, Germany, 47051
    - Novo Nordisk Investigational Site
  - Eisenach, Germany, 99817
    - Novo Nordisk Investigational Site
  - Erfurt, Germany, 99085
    - Novo Nordisk Investigational Site
  - Esslingen, Germany, 73728
    - Novo Nordisk Investigational Site
  - Frankfurt, Germany, 60388
    - Novo Nordisk Investigational Site
  - Freiburg, Germany, 79106
    - Novo Nordisk Investigational Site
  - Fulda, Germany, 36037
    - Novo Nordisk Investigational Site
  - Gifhorn, Germany, 38518
    - Novo Nordisk Investigational Site
  - Grevenbroich, Germany, 41515
    - Novo Nordisk Investigational Site
  - Hamburg, Germany, 22607
    - Novo Nordisk Investigational Site
  - Hamburg, Germany, 21073
    - Novo Nordisk Investigational Site
  - Hohenmölsen, Germany, 06679
    - Novo Nordisk Investigational Site
  - Jena, Germany, 07743
    - Novo Nordisk Investigational Site
  - Leipzig, Germany, 04103
    - Novo Nordisk Investigational Site
  - Leipzig, Germany, 04275
    - Novo Nordisk Investigational Site
  - Limburg, Germany, 65549
    - Novo Nordisk Investigational Site
  - Mainz, Germany, 55131
    - Novo Nordisk Investigational Site
  - Mainz-Ebersheim, Germany, 55129
    - Novo Nordisk Investigational Site
  - Mannheim, Germany, 68163
    - Novo Nordisk Investigational Site
  - München, Germany, 81925
    - Novo Nordisk Investigational Site
  - Münster, Germany, 48145
    - Novo Nordisk Investigational Site
  - Neuwied, Germany, 56564
    - Novo Nordisk Investigational Site
  - Rehlingen-Siersburg, Germany, 66780
    - Novo Nordisk Investigational Site
  - Rosenheim, Germany, 83022
    - Novo Nordisk Investigational Site
  - Schkeuditz, Germany, 04435
    - Novo Nordisk Investigational Site
  - Sinsheim, Germany, 74889
    - Novo Nordisk Investigational Site
  - St. Ingbert, Germany, 66386
    - Novo Nordisk Investigational Site
  - Stuttgart, Germany, 70184
    - Novo Nordisk Investigational Site
  - Wangen, Germany, 88239
    - Novo Nordisk Investigational Site
Italy
- - Ancona, Italy, 60100
    - Novo Nordisk Investigational Site
  - Caserta, Italy, 81100
    - Novo Nordisk Investigational Site
  - Catanzaro, Italy, 88100
    - Novo Nordisk Investigational Site
  - Catanzaro Lido, Italy
    - Novo Nordisk Investigational Site
  - Chiavari, Italy, 16043
    - Novo Nordisk Investigational Site
  - Cosenza, Italy, 87100
    - Novo Nordisk Investigational Site
  - Ferrara, Italy
    - Novo Nordisk Investigational Site
  - Lanciano, Italy
    - Novo Nordisk Investigational Site
  - Matera (mt), Italy, 75100
    - Novo Nordisk Investigational Site
  - Milano, Italy, 20162
    - Novo Nordisk Investigational Site
  - Milano, Italy
    - Novo Nordisk Investigational Site
  - Monserrato, Cagliari, Italy, 09042
    - Novo Nordisk Investigational Site
  - Monza, Italy, 20052
    - Novo Nordisk Investigational Site
  - Palermo, Italy, 90127
    - Novo Nordisk Investigational Site
  - Piacenza, Italy, 29100
    - Novo Nordisk Investigational Site
  - Primo Piano Palazzina Ambulato, Italy, 40133
    - Novo Nordisk Investigational Site
  - Ravenna, Italy, 48121
    - Novo Nordisk Investigational Site
  - Reggio Calabria, Italy, 89122
    - Novo Nordisk Investigational Site
  - Roma, Italy, 00133
    - Novo Nordisk Investigational Site
  - Terni, Italy, 05100
    - Novo Nordisk Investigational Site
  - Treviglio, Italy
    - Novo Nordisk Investigational Site
Netherlands
- - Amersfoort, Netherlands, 3816 CP
    - Novo Nordisk Investigational Site
  - Amsterdam, Netherlands, 1105 AZ
    - Novo Nordisk Investigational Site
  - Amsterdam, Netherlands, 1091 HA
    - Novo Nordisk Investigational Site
  - Beek, Netherlands, 6191JW
    - Novo Nordisk Investigational Site
  - Delft, Netherlands, 2625 AD
    - Novo Nordisk Investigational Site
  - Doetinchem, Netherlands, 7001 GW
    - Novo Nordisk Investigational Site
  - Eindhoven, Netherlands, 5616 GB
    - Novo Nordisk Investigational Site
  - Groningen, Netherlands, 9728 NT
    - Novo Nordisk Investigational Site
  - Heerlen, Netherlands, 6419 PC
    - Novo Nordisk Investigational Site
  - Hoofddorp, Netherlands, 2134 TM
    - Novo Nordisk Investigational Site
  - Hoogeveen, Netherlands, 7909 AA
    - Novo Nordisk Investigational Site
  - Leiden, Netherlands, 2334 CK
    - Novo Nordisk Investigational Site
  - Leiderdorp, Netherlands, 2352 RA
    - Novo Nordisk Investigational Site
  - Lichtenvoorde, Netherlands, 7131 CM
    - Novo Nordisk Investigational Site
  - Lieshout, Netherlands, 5737 CB
    - Novo Nordisk Investigational Site
  - Oude Pekela, Netherlands, 9665 AR
    - Novo Nordisk Investigational Site
  - Utrecht, Netherlands, 3584 CX
    - Novo Nordisk Investigational Site
  - Voorburg, Netherlands, 2275 CX
    - Novo Nordisk Investigational Site
  - Wildervank, Netherlands, 9648 BE
    - Novo Nordisk Investigational Site
  - Winschoten, Netherlands, 9671 CX
    - Novo Nordisk Investigational Site
Puerto Rico
- - Bayamon, Puerto Rico, 00961
    - Novo Nordisk Investigational Site
  - Carolina, Puerto Rico, 00983
    - Novo Nordisk Investigational Site
  - Trujillo Alto, Puerto Rico, 00976
    - Novo Nordisk Investigational Site
Spain
- - Almería, Spain, 04001
    - Novo Nordisk Investigational Site
  - Badajoz, Spain, 06080
    - Novo Nordisk Investigational Site
  - Badalona, Spain, 08916
    - Novo Nordisk Investigational Site
  - Bilbao, Spain, 48013
    - Novo Nordisk Investigational Site
  - Cartagena, Spain, 30203
    - Novo Nordisk Investigational Site
  - Cádiz, Spain, 11009
    - Novo Nordisk Investigational Site
  - Córdoba, Spain, 14004
    - Novo Nordisk Investigational Site
  - Girona, Spain, 17007
    - Novo Nordisk Investigational Site
  - Granada, Spain, 18012
    - Novo Nordisk Investigational Site
  - Madrid, Spain, 28006
    - Novo Nordisk Investigational Site
  - Madrid, Spain, 28040
    - Novo Nordisk Investigational Site
  - Madrid, Spain, 28031
    - Novo Nordisk Investigational Site
  - Majadahonda, Spain, 28222
    - Novo Nordisk Investigational Site
  - Pamplona, Spain, 31008
    - Novo Nordisk Investigational Site
  - Pontevedra, Spain, 36001
    - Novo Nordisk Investigational Site
  - Pozuelo de Alarcon, Spain, 28223
    - Novo Nordisk Investigational Site
  - Salamanca, Spain, 37007
    - Novo Nordisk Investigational Site
  - San Juan, Spain, 03550
    - Novo Nordisk Investigational Site
  - San Sebastián de los Reyes, Spain, 28700
    - Novo Nordisk Investigational Site
  - Santa Cruz de Tenerife, Spain, 38010
    - Novo Nordisk Investigational Site
  - Sevilla, Spain, 41013
    - Novo Nordisk Investigational Site
  - Tarrasa, Spain, 08221
    - Novo Nordisk Investigational Site
  - Valencia, Spain, 46010
    - Novo Nordisk Investigational Site
  - Xátiva, Spain, 46800
    - Novo Nordisk Investigational Site
  - Zaragoza, Spain, 50009
    - Novo Nordisk Investigational Site
United Kingdom
- - Aberdeen, United Kingdom, AB25 1LD
    - Novo Nordisk Investigational Site
  - Ashton-Under-Lyne, United Kingdom, OL6 9RW
    - Novo Nordisk Investigational Site
  - Bath, United Kingdom, BA1 3NG
    - Novo Nordisk Investigational Site
  - Belfast, United Kingdom, BT16 1RH
    - Novo Nordisk Investigational Site
  - Belfast, United Kingdom, BT12 6BA
    - Novo Nordisk Investigational Site
  - Belfast, United Kingdom, BT41 2RL
    - Novo Nordisk Investigational Site
  - Blackburn, United Kingdom, BB2 3HH
    - Novo Nordisk Investigational Site
  - Bradford, United Kingdom, BD9 6RJ
    - Novo Nordisk Investigational Site
  - Bristol, United Kingdom, BS2 8HW
    - Novo Nordisk Investigational Site
  - Coventry, United Kingdom, CV2 2DX
    - Novo Nordisk Investigational Site
  - Derby, United Kingdom, DE22 3NE
    - Novo Nordisk Investigational Site
  - Dundee, United Kingdom, DD1 9SY
    - Novo Nordisk Investigational Site
  - Edgbaston, Birmingham, United Kingdom, B15 2TH
    - Novo Nordisk Investigational Site
  - Edinburgh, United Kingdom, EH4 2XU
    - Novo Nordisk Investigational Site
  - Exeter, United Kingdom, EX2 5AX
    - Novo Nordisk Investigational Site
  - Guildford, United Kingdom, GU2 7XX
    - Novo Nordisk Investigational Site
  - Hull, United Kingdom, HU3 2JZ
    - Novo Nordisk Investigational Site
  - Inverness, United Kingdom, IV2 3UJ
    - Novo Nordisk Investigational Site
  - Leicester, United Kingdom, LE1 5WW
    - Novo Nordisk Investigational Site
  - Liverpool, United Kingdom, L7 8XP
    - Novo Nordisk Investigational Site
  - Liverpool, United Kingdom, L9 7AL
    - Novo Nordisk Investigational Site
  - London, United Kingdom, E1 2EF
    - Novo Nordisk Investigational Site
  - Londonderry, United Kingdom, BT47 6SB
    - Novo Nordisk Investigational Site
  - Manchester, United Kingdom, M8 5RB
    - Novo Nordisk Investigational Site
  - Manchester, United Kingdom, M41 5SL
    - Novo Nordisk Investigational Site
  - Northampton, United Kingdom, NN1 5BD
    - Novo Nordisk Investigational Site
  - Nuneaton, United Kingdom, CV10 7DJ
    - Novo Nordisk Investigational Site
  - Oxford, United Kingdom, OX3 7LE
    - Novo Nordisk Investigational Site
  - Rugby, United Kingdom, CV22 5PX
    - Novo Nordisk Investigational Site
  - Salford, United Kingdom, M6 8HD
    - Novo Nordisk Investigational Site
  - Swansea, United Kingdom, SA6 6NL
    - Novo Nordisk Investigational Site
  - Welwyn Garden City, United Kingdom, AL7 4HQ
    - Novo Nordisk Investigational Site
United States
- Alabama
  - Alexander City, Alabama, United States, 35010
    - Novo Nordisk Investigational Site
  - Birmingham, Alabama, United States, 35294
    - Novo Nordisk Investigational Site
- California
  - Encino, California, United States, 91436
    - Novo Nordisk Investigational Site
  - Fullerton, California, United States, 92835
    - Novo Nordisk Investigational Site
  - Inglewood, California, United States, 90301
    - Novo Nordisk Investigational Site
  - La Jolla, California, United States, 92037
    - Novo Nordisk Investigational Site
  - Los Gatos, California, United States, 95032
    - Novo Nordisk Investigational Site
  - Montclair, California, United States, 91763
    - Novo Nordisk Investigational Site
  - Spring Valley, California, United States, 91978
    - Novo Nordisk Investigational Site
  - Tustin, California, United States, 92780
    - Novo Nordisk Investigational Site
  - Walnut Creek, California, United States, 94598
    - Novo Nordisk Investigational Site
- Connecticut
  - Waterbury, Connecticut, United States, 06712
    - Novo Nordisk Investigational Site
- Florida
  - Bradenton, Florida, United States, 34201
    - Novo Nordisk Investigational Site
  - Clearwater, Florida, United States, 33765
    - Novo Nordisk Investigational Site
  - Jupiter, Florida, United States, 33458-7200
    - Novo Nordisk Investigational Site
  - Miami, Florida, United States, 33156
    - Novo Nordisk Investigational Site
  - Miami, Florida, United States, 33136
    - Novo Nordisk Investigational Site
  - Miami, Florida, United States, 33169
    - Novo Nordisk Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30308-2253
    - Novo Nordisk Investigational Site
  - Decatur, Georgia, United States, 30033
    - Novo Nordisk Investigational Site
  - Roswell, Georgia, United States, 30076
    - Novo Nordisk Investigational Site
  - Savannah, Georgia, United States, 31405
    - Novo Nordisk Investigational Site
- Illinois
  - Chicago, Illinois, United States, 60616
    - Novo Nordisk Investigational Site
  - Quincy, Illinois, United States, 62301
    - Novo Nordisk Investigational Site
- Indiana
  - Chicago Heights, Indiana, United States, 60411
    - Novo Nordisk Investigational Site
- Kentucky
  - Louisville, Kentucky, United States, 40213
    - Novo Nordisk Investigational Site
  - Madisonville, Kentucky, United States, 42431
    - Novo Nordisk Investigational Site
- Maryland
  - Baltimore, Maryland, United States, 21204
    - Novo Nordisk Investigational Site
  - Hyattsville, Maryland, United States, 20782
    - Novo Nordisk Investigational Site
  - Rockville, Maryland, United States, 20852
    - Novo Nordisk Investigational Site
- Massachusetts
  - Methuen, Massachusetts, United States, 01844
    - Novo Nordisk Investigational Site
- Missouri
  - St. Louis, Missouri, United States, 63104
    - Novo Nordisk Investigational Site
- New York
  - Bronx, New York, United States, 10461-2665
    - Novo Nordisk Investigational Site
  - New Hyde Park, New York, United States, 11042
    - Novo Nordisk Investigational Site
  - Northport, New York, United States, 11768
    - Novo Nordisk Investigational Site
  - Syracuse, New York, United States, 13210
    - Novo Nordisk Investigational Site
- North Carolina
  - Charlotte, North Carolina, United States, 28277
    - Novo Nordisk Investigational Site
  - Durham, North Carolina, United States, 27710
    - Novo Nordisk Investigational Site
- Ohio
  - Cincinnati, Ohio, United States, 45245
    - Novo Nordisk Investigational Site
  - Cincinnati, Ohio, United States, 45226
    - Novo Nordisk Investigational Site
  - Dayton, Ohio, United States, 45439
    - Novo Nordisk Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73103
    - Novo Nordisk Investigational Site
- Pennsylvania
  - Danville, Pennsylvania, United States, 17822
    - Novo Nordisk Investigational Site
  - Philadelphia, Pennsylvania, United States, 19152
    - Novo Nordisk Investigational Site
  - State College, Pennsylvania, United States, 16801
    - Novo Nordisk Investigational Site
  - Willkes Barre, Pennsylvania, United States, 18702
    - Novo Nordisk Investigational Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37411
    - Novo Nordisk Investigational Site
  - Memphis, Tennessee, United States, 38119
    - Novo Nordisk Investigational Site
- Texas
  - Corpus Christi, Texas, United States, 78412
    - Novo Nordisk Investigational Site
  - Dallas, Texas, United States, 75230
    - Novo Nordisk Investigational Site
  - Dallas, Texas, United States, 75390-9302
    - Novo Nordisk Investigational Site
  - Dallas, Texas, United States, 75231
    - Novo Nordisk Investigational Site
  - Dallas, Texas, United States, 75246
    - Novo Nordisk Investigational Site
  - Dallas, Texas, United States, 75235-6233
    - Novo Nordisk Investigational Site
  - Midland, Texas, United States, 79707
    - Novo Nordisk Investigational Site
  - Plano, Texas, United States, 75075
    - Novo Nordisk Investigational Site
- Utah
  - Orem, Utah, United States, 84058
    - Novo Nordisk Investigational Site
- Virginia
  - Richmond, Virginia, United States, 23294
    - Novo Nordisk Investigational Site
  - Richmond, Virginia, United States, 23249
    - Novo Nordisk Investigational Site
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53209
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lira 1.8 Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%	Drug: liraglutide Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection. Drug: metformin Metformin tablets, at least 1500 mg/day
Experimental: Insulin detemir + Lira 1.8 Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%	Drug: liraglutide Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection. Drug: metformin Metformin tablets, at least 1500 mg/day Drug: insulin detemir Insulin detemir subcutaneous (under the skin) injection once daily. Dose will be titrated (individually adjusted) based on fasting self-measured plasma glucose levels according to a pre-specified algorithm
Experimental: Non-Randomised Lira 1.8 Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%	Drug: liraglutide Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection. Drug: metformin Metformin tablets, at least 1500 mg/day
Other: Early Withdrawals Lira 1.8 Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject's own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial	Drug: liraglutide Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection. Drug: metformin Metformin tablets, at least 1500 mg/day
Other: Intensified group Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.	Drug: liraglutide Liraglutide 1.8 mg/day for subcutaneous (under the skin) injection. Drug: metformin Metformin tablets, at least 1500 mg/day Drug: insulin detemir Insulin detemir subcutaneous (under the skin) injection once daily. Dose will be titrated (individually adjusted) based on fasting self-measured plasma glucose levels according to a pre-specified algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26. Time Frame: Week 0 (Randomisation), week 26	Week 0 (Randomisation), week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for Intensified Subjects in Original Treatment Group) Time Frame: Week 0, Week 52		Week 0, Week 52
Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values Before Intensification as LOCF) Time Frame: Week 0, Week 52		Week 0, Week 52
Mean Change From Randomisation in Fasting Plasma Glucose at Week 26 Time Frame: Week 0 (Randomisation), Week 26		Week 0 (Randomisation), Week 26
Mean Change From Randomisation in Fasting Plasma Glucose at Week 52 Time Frame: Week 0, Week 52		Week 0, Week 52
Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 26 Time Frame: Week 0 (Randomisation), Week 26	Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline/randomisation (week 0) to 26 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.	Week 0 (Randomisation), Week 26
Mean Change From Randomisation in 7-point Plasma Glucose Profile (Self-measured) at Week 52 Time Frame: Week 0, Week 52	Calculated as an estimate of the change in mean prandial increment of plasma glucose after breakfast, lunch and dinner (from baseline (week 0) to 52 weeks), respectively. Prandial increments of plasma glucose were calculated as the difference between glucose values measured before and after each of these three meals, respectively.	Week 0, Week 52
Mean Change From Randomisation in Fasting Insulin at Week 26 Time Frame: Week 0 (Randomisation), Week 26		Week 0 (Randomisation), Week 26
Mean Change From Randomisation in Fasting Insulin at Week 52 Time Frame: Week 0 (Randomisation), Week 52		Week 0 (Randomisation), Week 52
Mean Change From Randomisation in Fasting Pro-insulin at Week 26. Time Frame: Week 0 (Randomisation), Week 26		Week 0 (Randomisation), Week 26
Mean Change From Randomisation in Fasting Pro-insulin at Week 52 Time Frame: Week 0, Week 52		Week 0, Week 52
Mean Change From Randomisation in Fasting C-peptide at Week 26. Time Frame: Week 0 (Randomisation), Week 26		Week 0 (Randomisation), Week 26
Mean Change From Randomisation in Fasting C-peptide at Week 52. Time Frame: Week 0, Week 52		Week 0, Week 52
Mean Changes From Randomisation in Cholesterol Lipids at Week 26. Time Frame: Week 0 (Randomisation), Week 26	Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)	Week 0 (Randomisation), Week 26
Mean Changes From Randomisation in Cholesterol Lipids at Week 52. Time Frame: Week 0, Week 52	Cholesterol Lipids cover: Total Cholesterol, Low-density Lipoprotein Cholesterol (LDL-C), Very Low Density Lipoprotein Cholesterol (VLDL-C), High Density Lipoprotein Cholesterol (HDL-C)	Week 0, Week 52
Mean Change From Randomisation in Lipids: Triglycerides at Week 26 Time Frame: Week 0 (Randomisation), Week 26		Week 0 (Randomisation), Week 26
Mean Change From Randomisation in Lipids: Triglycerides at Week 52 Time Frame: Week 0, Week 52		Week 0, Week 52
Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 26 Time Frame: Week 0 (Randomisation), Week 26		Week 0 (Randomisation), Week 26
Mean Change From Randomisation in Lipids: Free Fatty Acids (FFA) at Week 52 Time Frame: Week 0, Week 52		Week 0, Week 52
Mean Change From Randomisation in Body Weight at Week 26 Time Frame: Week 0 (Randomisation), Week 26		Week 0 (Randomisation), Week 26
Mean Change From Randomisation in Body Weight at Week 52 Time Frame: Week 0, Week 52		Week 0, Week 52
Mean Change From Randomisation in Waist Circumference at Week 26. Time Frame: Week 0 (Randomisation), Week 26		Week 0 (Randomisation), Week 26
Mean Change From Randomisation in Waist Circumference at Week 52. Time Frame: Week 0, Week 52		Week 0, Week 52
Mean Change From Randomisation in Hip Circumference at Week 26 Time Frame: Week 0 (Randomisation), Week 26		Week 0 (Randomisation), Week 26
Mean Change From Randomisation in Hip Circumference at Week 52 Time Frame: Week 0, week 52		Week 0, week 52
Mean Change From Randomisation in Waist to Hip Ratio at Week 26 Time Frame: Week 0 (Randomisation), Week 26	Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference	Week 0 (Randomisation), Week 26
Mean Change From Randomisation in Waist to Hip Ratio at Week 52 Time Frame: Week 0, Week 52	Waist to Hip Ratio is calculated by dividing Waist circumference with Hip circumference	Week 0, Week 52
Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 26. Time Frame: Week 0 (Randomisation), Week 26		Week 0 (Randomisation), Week 26
Mean Change From Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52. Time Frame: Week 0, Week 52		Week 0, Week 52
Adverse Events From Run-in (Week -12) to Week 52 Time Frame: Run-in (week -12) to Week 52		Run-in (week -12) to Week 52
Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26 Time Frame: weeks 0-26	Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.	weeks 0-26
Hypoglycaemic Episodes Weeks 0-52 Time Frame: Week 0-52	Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.	Week 0-52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (Estimate)

March 6, 2009

Study Record Updates

Last Update Posted (Actual)

March 8, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

NN2211-1842
2007-005317-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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