Primary outcome
What NCT00614120 measured first
| Lira 0.6 + Metn=226 | Lira 1.2 + Metn=222 | Lira 1.8 + Metn=221 | Glim + Metn=230 |
|---|---|---|---|
| -1.0(1.04) | -1.3(1.09) | -1.4(1.23) | -1.3(0.98) |
Phase 3 · Liraglutide
NCT00614120 trial results
Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes
Change in Glycosylated Haemoglobin A1c (HbA1c) (percentage point of total HbA1c), week 0, week 16. Lira 0.6 + Met: -1.0; Lira 1.2 + Met: -1.3; Lira 1.8 + Met: -1.4; Glim + Met: -1.3.
- Participants
- 929
- Status
- completed
- Completed
- 2009-02
- Sponsor
- Novo Nordisk A/S
As posted on ClinicalTrials.gov (NCT00614120), 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 NCT00614120
Percent of participants affected, The adverse events were collected over a time span of 16 weeks.. The most common events the registry lists.
| Event | Lira 0.6 + Met | Lira 1.2 + Met | Lira 1.8 + Met | Glim + Met |
|---|---|---|---|---|
| Any serious event | 1.7% | 3.4% | 1.7% | 1.7% |
| Diarrhoea | 12.1% | 15.5% | 17.2% | 8.7% |
| Nausea | 12.6% | 13.7% | 16.3% | 2.2% |
| Anorexia | 3% | 14.2% | 15% | 1.7% |
| Vomiting | 7.4% | 9.4% | 14.2% | 1.7% |
| Dyspepsia | 3% | 6.9% | 5.2% | 0.4% |
| Decreased appetite | 4.3% | 5.2% | 3% | 0.4% |
| Asthenia | 1.7% | 4.3% | 5.2% | 1.3% |
Secondary outcomes
What else it measured
| Lira 0.6 + Metn=227 | Lira 1.2 + Metn=225 | Lira 1.8 + Metn=224 | Glim + Metn=231 |
|---|---|---|---|
| -1.8(2.2) | -2.3(2.4) | -2.4(2.6) | 0.1(2.2) |
| Lira 0.6 + Metn=224 | Lira 1.2 + Metn=226 | Lira 1.8 + Metn=222 | Glim + Metn=229 |
|---|---|---|---|
| -1.83(2.66) | -1.96(2.35) | -2.28(2.94) | -2.13(2.25) |
| Measure | Lira 0.6 + Metn=231 | Lira 1.2 + Metn=233 | Lira 1.8 + Metn=233 | Glim + Metn=231 |
|---|---|---|---|---|
| Week 0 - Before breakfast | 168.2(43.5) | 167.5(42.5) | 168.8(40.4) | 163.8(41.2) |
| Week 0 - 90 minutes after breakfast | 245.9(71.6) | 248.0(70.0) | 245.4(63.8) | 238.5(62.4) |
| Week 0 - Before lunch | 178.5(62.7) | 180.5(63.5) | 176.9(56.8) | 175.8(61.0) |
| Week 0 - 90 minutes after lunch | 234.2(68.7) | 232.3(67.0) | 234.4(64.2) | 227.6(67.0) |
| Week 0 - Before dinner | 194.8(63.0) | 184.8(65.0) | 190.9(61.7) | 180.2(59.2) |
| Week 0 - 90 minutes after dinner | 239.6(65.3) | 239.6(71.3) | 244.0(69.8) | 231.6(60.3) |
| Week 0 - Bedtime | 205.7(69.6) | 208.1(67.5) | 219.3(71.7) | 202.7(66.4) |
| Week 8 - Before breakfast | 137.0(31.2) | 130.4(28.0) | 133.7(28.4) | 130.1(31.8) |
| Week 8 - 90 minutes after breakfast | 198.5(55.8) | 190.1(50.8) | 178.5(48.2) | 201.2(54.4) |
| Week 8 - Before lunch | 144.8(45.2) | 136.5(41.8) | 138.0(37.8) | 132.6(46.1) |
| Week 8 - 90 minutes after lunch | 187.2(48.7) | 176.9(49.5) | 177.9(48.4) | 184.3(54.2) |
| Week 8 - Before dinner | 159.1(47.5) | 147.8(40.1) | 144.2(40.6) | 143.3(47.8) |
| Lira 0.6 + Metn=216 | Lira 1.2 + Metn=216 | Lira 1.8 + Metn=213 | Glim + Metn=222 |
|---|---|---|---|
| 15.3(94.6) | 17.8(30.4) | 21.7(78.5) | 21.8(43.1) |
| Measure | Lira 0.6 + Metn=231 | Lira 1.2 + Metn=233 | Lira 1.8 + Metn=233 | Glim + Metn=231 |
|---|---|---|---|---|
| Change in TC (Absolute), N=221, 216, 216, 228 | 0.06(0.74) | -0.01(0.77) | -0.03(0.73) | 0.02(0.73) |
| Change in LDL-C (Absolute), N=221, 216, 216, 228 | 0.06(0.61) | -0.03(0.64) | 0.00(0.58) | 0.04(0.55) |
| Change in VLDL-C (Absolute), N=213, 210, 207, 220 | 0.03(0.35) | 0.05(0.40) | 0.01(0.35) | 0.05(0.42) |
| Change in HDL-C (Absolute), N=217, 212, 212, 220 | -0.02(0.19) | -0.05(0.34) | -0.05(0.15) | -0.01(0.34) |
| Change in TG (Absolute), N=220, 212, 213, 226 | -0.08(0.96) | -0.06(1.13) | -0.22(1.57) | -0.07(1.26) |
| Change in FFA (Absolute), N=218, 214, 216, 227 | -0.03(0.28) | -0.04(0.28) | -0.10(0.28) | -0.02(0.28) |
| Lira 0.6 + Metn=221 | Lira 1.2 + Metn=216 | Lira 1.8 + Metn=216 | Glim + Metn=228 |
|---|---|---|---|
| 0.02(0.17) | 0.00(0.18) | -0.00(0.16) | 0.01(0.17) |
| Measure | Lira 0.6 + Metn=231 | Lira 1.2 + Metn=233 | Lira 1.8 + Metn=233 | Glim + Metn=231 |
|---|---|---|---|---|
| Major | 0 | 0 | 0 | 2 |
| Minor | 6 | 0 | 5 | 80 |
| Symptoms only | 12 | 11 | 9 | 86 |
The trial
How NCT00614120 was run
This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes
- Lira 0.6 + Met: Liraglutide 0.6 mg + metformin + glimepiride placebo
- Lira 1.2 + Met: Liraglutide 1.2 mg + metformin + glimepiride placebo
- Lira 1.8 + Met: Liraglutide + metformin + glimepiride placebo
- Glim + Met: Glimepiride 4.0 mg + metformin + liraglutide placebo
Who could join the trial
Inclusion Criteria: * Type 2 diabetes * Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months * HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone * HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy * BMI less than 45.0 kg/m\^2 Exclusion Criteria: * Treatment with insulin within the last 3 months prior to the trial * Impaired liver or/and renal function * Significant cardiovascular disease over the last 6 months * Known retinopathy or maculopathy * Recurrent major hypoglycaemia or hypoglycaemic unawareness
Published papers
Papers from NCT00614120
- Yang W, Chen L, Ji Q, Liu X, Ma J, Tandon N, Bhattacharyya A, Kumar A, Kim KW, Yoon KH, Bech OM, Zychma M. Liraglutide provides similar glycaemic control as glimepiride (both in combination with metformin) and reduces body weight and systolic blood pressure in Asian population with type 2 diabetes from China, South Korea and India: a 16-week, randomized, double-blind, active control trial(*). Diabetes Obes Metab. 2011 Jan;13(1):81-8. doi: 10.1111/j.1463-1326.2010.01323.x.
- Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.
- 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.
- Ingwersen SH, Petri KC, Tandon N, Yoon KH, Chen L, Vora J, Yang W. Liraglutide pharmacokinetics and dose-exposure response in Asian subjects with Type 2 diabetes from China, India and South Korea. Diabetes Res Clin Pract. 2015 Apr;108(1):113-9. doi: 10.1016/j.diabres.2015.01.001. Epub 2015 Jan 19.
- Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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