The effect of insulin detemir in combination with liraglutide and metformin compared to liraglutide and metformin in subjects with type 2 diabetes
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1 The effect of insulin detemir in combination with liraglutide and metformin compared to liraglutide and metformin in subjects with type 2 diabetes 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. Scientific Title The effect of insulin detemir in combination with liraglutide and metformin compared to liraglutide and metformin in subjects with type 2 diabetes. A week, randomised, open-label, parallel-group, multicentre, multinational trial with a week extension Trial IDs and acronym(s) Novo Nordisk Trial ID NN Clinical Trials.gov Registration NCT Other Identifier(s) EudraCT Number: Condition Diabetes Diabetes Mellitus, Type 2 Trial dates Start date: 03.Mar.2009 Primary completion date: 19.Apr.2010 Completion date: 01.Nov.2010 Trial phase Phase 3 Treatment liraglutide insulin detemir metformin Arm Information with Assigned Treatment No. of arms: 5 Lira 1.8 (Experimental): 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 weeks plus weeks extension, when the HbA1c assessment after run-in period was at least 7.0% Page 1
2 Insulin detemir + Lira 1.8 (Experimental): 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 weeks plus weeks extension, when the HbA1c assessment after run-in period was at least 7.0% 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 Non-Randomised Lira 1.8 (Experimental): 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 weeks plus weeks extension, when the HbA1c assessment after run-in period was below 7.0% Early Withdrawals Lira 1.8 (Other): 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 Intensified group (Other): Arm description: Intensification of treatment with insulin detemir was offered at Weeks Page 2
3 and 38 for subjects with an HbA1c 8.0% in the randomised Lira 1.8 group and nonrandomised liraglutide treatment group. 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 Trial status Completed No. of trial participants 987 Age eligible for trial participation 18 years to 84 years Genders eligible for trial participation Both 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 shortterm insulin treatment in connection with intercurrent illness is allowed at the discretion of the Investigator HbA1c % (both inclusive) for subjects on metformin monotherapy HbA1c % (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 Trial type Interventional Trial design Purpose: Treatment Allocation: Randomized Masking: Control: Active Control Assignment: Parallel Assignment Page 3
4 Primary outcome Mean Change from Randomisation in Mean Change from Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week. Time frame: Week 0 (Randomisation), week Secondary outcome(s) Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (for intensified subjects in original treatment group) Mean Change from Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 52 (Values before Intensification as LOCF) Mean change from Randomisation in Fasting Plasma Glucose at Week Mean change from Randomisation in Fasting Plasma Glucose at Week 52 Mean Change from Randomisation in 7-point Plasma Glucose Profile (self-measured) at Week Mean Change from Randomisation in 7-point Plasma Glucose Profile (self-measured) at Week 52 insulin at Week insulin at Week Pro-insulin at Week. Pro-insulin at Week 52 C-peptide at Week. Page 4
5 C-peptide at Week 52. Mean Changes from Randomisation in Cholesterol Lipids at Week. Mean Changes from Randomisation in Cholesterol Lipids at Week 52. Triglycerides at Week Triglycerides at Week 52 Free Fatty Acids (FFA) at Week Free Fatty Acids (FFA) at Week 52 Mean Change from Randomisation in Body Weight at Week Mean Change from Randomisation in Body Weight at Week 52 Circumference at Week. Circumference at Week 52. Mean Change from Randomisation in Hip Circumference at Week Mean Change from Randomisation in Hip Circumference at Week 52 Time frame: Week 0, week 52 Page 5
6 to Hip ratio at Week to Hip ratio at Week 52 Mean Change from Randomisation in Blood Pressure (Systolic and Diastolic) at Week. Mean Change from Randomisation in Blood Pressure (Systolic and Diastolic) at Week 52. Adverse Events from Run-in (week -12) to Week 52 Time frame: Run-in (week -12) to Week 52 Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0- Time frame: weeks 0- Hypoglycaemic Episodes Weeks 0-52 Time frame: Week 0-52 Participating countries Belgium: Completed Canada: Completed France: Completed/Suspended Germany: Completed/Suspended Italy: Completed/Suspended Netherlands: Completed/Suspended Spain: Completed/Suspended United Kingdom: Completed United States: Completed/Suspended Central contact information Trial sponsored by: Novo Nordisk A/S Contact: For trials conducted in the US: (+1) Labeling information EU: url=menus/medicines/medicines.jsp&mid=wc0b01ac058001d125 US: Information provided by Novo Nordisk A/S Page 6
7 PDF generation date: 12.Jan Page 7
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