Primary outcome
What NCT00856986 measured first
| Lira 1.8n=149 | Insulin Detemir + Lira 1.8n=160 | Non-Randomised Lira 1.8n=0 | Early Withdrawals Lira 1.8n=0 | Intensified Groupn=0 |
|---|---|---|---|---|
| 0.02(0.07) | -0.51(0.07) | not reported | not reported | not reported |
Phase 3 · Liraglutide
NCT00856986 trial results
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
Mean Change From Randomisation in Glycosylated Haemoglobin A1c (HbA1c) at Week 26. (Percentage point of total HbA1c), Week 0 (Randomisation), week 26. Lira 1.8: 0.02; Insulin Detemir + Lira 1.8: -0.51.
- Participants
- 987
- Status
- completed
- Completed
- 2010-11
- Sponsor
- Novo Nordisk A/S
As posted on ClinicalTrials.gov (NCT00856986), updated at source Mar 8, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT00856986
Percent of participants affected, The adverse events were collected in a timeframe of 64 weeks (from run-in to week 52).. The most common events the registry lists.
| Event | Lira 1.8 | Insulin Detemir + Lira 1.8 | Non-Randomised Lira 1.8 | Early Withdrawals Lira 1.8 | Intensified Group |
|---|---|---|---|---|---|
| Any serious event | 6.9% | 10.4% | 12.4% | 3.6% | 4.2% |
| Nausea | 23.3% | 18.4% | 27.3% | 39.8% | 4.2% |
| Nasopharyngitis | 25.2% | 20.2% | 14.4% | 1.2% | 12.5% |
| Dyspepsia | 5% | 6.1% | 8.4% | 19.9% | 0% |
| Diarrhoea | 16.4% | 17.8% | 14.8% | 12.7% | 4.2% |
| Lipase Increased | 10.1% | 16% | 11% | 3.6% | 16.7% |
| Headache | 14.5% | 12.9% | 14.6% | 7.8% | 8.3% |
| Vomiting | 11.9% | 10.4% | 10% | 12.7% | 0% |
| Decreased Appetite | 5.7% | 8% | 10% | 10.2% | 0% |
| Upper respiratory tract infection | 5.7% | 8% | 4.2% | 0% | 0% |
| Fatigue | 5.7% | 7.4% | 3% | 3.6% | 0% |
| Constipation | 6.9% | 4.9% | 5% | 6.6% | 0% |
| Back Pain | 6.3% | 2.5% | 5.2% | 2.4% | 4.2% |
| Oropharyngeal Pain | 6.3% | 3.1% | 3.4% | 1.2% | 0% |
| Abdominal Pain | 5% | 3.7% | 2.8% | 3% | 0% |
Secondary outcomes
What else it measured
| Lira 1.8n=149 | Insulin Detemir + Lira 1.8n=160 | Non-Randomised Lira 1.8n=0 | Early Withdrawals Lira 1.8n=0 | Intensified Groupn=0 |
|---|---|---|---|---|
| -0.1(0.09) | -0.51(0.09) | not reported | not reported | not reported |
| Lira 1.8n=149 | Insulin Detemir + Lira 1.8n=160 | Non-Randomised Lira 1.8n=0 | Early Withdrawals Lira 1.8n=0 | Intensified Groupn=0 |
|---|---|---|---|---|
| 0.01(0.09) | -0.5(0.09) | not reported | not reported | not reported |
| Lira 1.8n=154 | Insulin Detemir + Lira 1.8n=160 | Non-Randomised Lira 1.8n=0 | Early Withdrawals Lira 1.8n=0 | Intensified Groupn=0 |
|---|---|---|---|---|
| -0.39(0.19) | -2.12(0.19) | not reported | not reported | not reported |
| Lira 1.8n=154 | Insulin Detemir + Lira 1.8n=160 | Non-Randomised Lira 1.8n=0 | Early Withdrawals Lira 1.8n=0 | Intensified Groupn=0 |
|---|---|---|---|---|
| -0.14(0.21) | -1.91(0.21) | not reported | not reported | not reported |
| Measure | Lira 1.8n=133 | Insulin Detemir + Lira 1.8n=144 | Non-Randomised Lira 1.8n=0 | Early Withdrawals Lira 1.8n=0 | Intensified Groupn=0 |
|---|---|---|---|---|---|
| Change at Breakfast, N=133, 144 | -0.97(0.26) | -2.09(0.26) | not reported | not reported | not reported |
| Change at Lunch, N= 134, 143 | -0.83(0.22) | -1.43(0.22) | not reported | not reported | not reported |
| Change at Dinner, N= 133, 139 | -0.48(0.24) | -1.18(0.24) | not reported | not reported | not reported |
| Measure | Lira 1.8n=136 | Insulin Detemir + Lira 1.8n=148 | Non-Randomised Lira 1.8n=0 | Early Withdrawals Lira 1.8n=0 | Intensified Groupn=0 |
|---|---|---|---|---|---|
| Change at Breakfast, N=148, 135 | -0.68(0.25) | -2.43(0.25) | not reported | not reported | not reported |
| Change at Lunch, N= 145, 136 | -0.51(0.25) | -1.14(0.25) | not reported | not reported | not reported |
| Change at Dinner, N= 144, 135 | -0.96(0.26) | -1.4(0.25) | not reported | not reported | not reported |
| Lira 1.8n=135 | Insulin Detemir + Lira 1.8n=152 | Non-Randomised Lira 1.8n=0 | Early Withdrawals Lira 1.8n=0 | Intensified Groupn=0 |
|---|---|---|---|---|
| -1.12(3.27) | -9.78(3.22) | not reported | not reported | not reported |
| Lira 1.8n=139 | Insulin Detemir + Lira 1.8n=152 | Non-Randomised Lira 1.8n=0 | Early Withdrawals Lira 1.8n=0 | Intensified Groupn=0 |
|---|---|---|---|---|
| 1.47(3.08) | -4(3.08) | not reported | not reported | not reported |
| Lira 1.8n=136 | Insulin Detemir + Lira 1.8n=149 | Non-Randomised Lira 1.8n=0 | Early Withdrawals Lira 1.8n=0 | Intensified Groupn=0 |
|---|---|---|---|---|
| -0.08(0.04) | -0.32(0.04) | not reported | not reported | not reported |
| Lira 1.8n=139 | Insulin Detemir + Lira 1.8n=150 | Non-Randomised Lira 1.8n=0 | Early Withdrawals Lira 1.8n=0 | Intensified Groupn=0 |
|---|---|---|---|---|
| 0.02(0.05) | -0.34(0.05) | not reported | not reported | not reported |
| Measure | Lira 1.8n=141 | Insulin Detemir + Lira 1.8n=152 | Non-Randomised Lira 1.8n=0 | Early Withdrawals Lira 1.8n=0 | Intensified Groupn=0 |
|---|---|---|---|---|---|
| Change in Total Cholesterol | 0.04(0.07) | 0.05(0.07) | not reported | not reported | not reported |
| Change in LDL-C | -0.04(0.06) | -0.03(0.06) | not reported | not reported | not reported |
| Change in VLDL-C | 0.05(0.03) | 0.01(0.03) | not reported | not reported | not reported |
| Change in HDL-C | 0.02(0.01) | 0.05(0.01) | not reported | not reported | not reported |
| Measure | Lira 1.8n=141 | Insulin Detemir + Lira 1.8n=153 | Non-Randomised Lira 1.8n=0 | Early Withdrawals Lira 1.8n=0 | Intensified Groupn=0 |
|---|---|---|---|---|---|
| Change in Total Cholesterol | -0.02(0.08) | -0.03(0.08) | not reported | not reported | not reported |
| Change in LDL-C | -0.08(0.07) | -0.1(0.07) | not reported | not reported | not reported |
| Change in VLDL-C | 0.03(0.04) | -0.03(0.04) | not reported | not reported | not reported |
| Change in HDL-C | 0.02(0.02) | 0.07(0.02) | not reported | not reported | not reported |
The trial
How NCT00856986 was run
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.
- 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...
- 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,...
- 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%
- 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
- 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.
Who could join the trial
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
Published papers
Papers from NCT00856986
- 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.
- 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.
- 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.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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