Primary outcome
What NCT00395746 measured first
| 0.6 mg + SUn=86 | 0.9 mg + SUn=87 | SU Monon=88 |
|---|---|---|
| 7.02(0.10) | 6.75(0.11) | 8.02(0.10) |
Phase 3 · Liraglutide
NCT00395746 trial results
Effect of Liraglutide in Combination With Sulfonylurea (SU) on Glycaemic Control in Subjects With Type 2 Diabetes
Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment (percentage of total haemoglobin), after 24 weeks of treatment. 0.6 mg + SU: 7.02; 0.9 mg + SU: 6.75; SU Mono: 8.02.
- Participants
- 264
- Status
- completed
- Completed
- 2008-05
- Sponsor
- Novo Nordisk A/S
As posted on ClinicalTrials.gov (NCT00395746), 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 NCT00395746
Percent of participants affected, Adverse events were collected in a time span over 52 weeks.. The most common events the registry lists.
| Event | 0.6 mg + SU | 0.9 mg + SU | SU Mono |
|---|---|---|---|
| Any serious event | 4.5% | 3.4% | 5.7% |
| Nasopharyngitis | 42% | 43.2% | 39.8% |
| Diarrhoea | 8% | 15.9% | 8% |
| Constipation | 9.1% | 12.5% | 4.5% |
| Diabetic retinopathy | 9.1% | 12.5% | 8% |
| Back pain | 11.4% | 8% | 6.8% |
| Headache | 11.4% | 4.5% | 9.1% |
| Upper respiratory tract inflammation | 10.2% | 6.8% | 5.7% |
| Gastritis | 3.4% | 4.5% | 9.1% |
| Arthralgia | 6.8% | 3.4% | 1.1% |
| Dizziness | 5.7% | 6.8% | 2.3% |
| Alanine aminotransferase increased | 6.8% | 2.3% | 1.1% |
| Dental caries | 5.7% | 5.7% | 1.1% |
| Hypoaesthesia | 5.7% | 0% | 5.7% |
| Malaise | 5.7% | 1.1% | 5.7% |
| Fall | 5.7% | 2.3% | 2.3% |
| Hypertension | 5.7% | 3.4% | 4.5% |
Secondary outcomes
What else it measured
| 0.6 mg + SUn=86 | 0.9 mg + SUn=87 | SU Monon=88 |
|---|---|---|
| 7.42(0.12) | 7.06(0.13) | 8.39(0.12) |
| 0.6 mg + SUn=85 | 0.9 mg + SUn=86 | SU Monon=87 |
|---|---|---|
| 132.2(3.5) | 126.2(3.5) | 158.8(3.5) |
| 0.6 mg + SUn=85 | 0.9 mg + SUn=86 | SU Monon=87 |
|---|---|---|
| 140.3(4.0) | 134.5(4.1) | 164.6(4.0) |
| 0.6 mg + SUn=83 | 0.9 mg + SUn=84 | SU Monon=71 |
|---|---|---|
| 614.58(14.75) | 575.50(15.01) | 725.72(15.71) |
| 0.6 mg + SUn=78 | 0.9 mg + SUn=83 | SU Monon=68 |
|---|---|---|
| 648.87(16.09) | 589.98(16.17) | 717.55(17.08) |
| 0.6 mg + SUn=80 | 0.9 mg + SUn=82 | SU Monon=80 |
|---|---|---|
| 160.20(4.44) | 150.05(4.56) | 194.50(4.61) |
| 0.6 mg + SUn=81 | 0.9 mg + SUn=80 | SU Monon=82 |
|---|---|---|
| 171.42(5.11) | 159.58(5.30) | 205.92(5.25) |
| 0.6 mg + SUn=81 | 0.9 mg + SUn=82 | SU Monon=82 |
|---|---|---|
| 86.38(4.65) | 68.34(4.78) | 79.71(4.75) |
| 0.6 mg + SUn=82 | 0.9 mg + SUn=80 | SU Monon=85 |
|---|---|---|
| 82.28(4.81) | 76.09(5.00) | 89.39(4.86) |
| 0.6 mg + SUn=87 | 0.9 mg + SUn=87 | SU Monon=88 |
|---|---|---|
| 65.77(0.23) | 65.34(0.24) | 64.59(0.23) |
| 0.6 mg + SUn=87 | 0.9 mg + SUn=87 | SU Monon=88 |
|---|---|---|
| 65.96(0.26) | 65.87(0.27) | 64.83(0.26) |
| Measure | 0.6 mg + SUn=88 | 0.9 mg + SUn=88 | SU Monon=88 |
|---|---|---|---|
| All hypoglycaemic episodes | 3.131 | 3.715 | 2.990 |
| Major | 0.0000 | 0.0000 | 0.0000 |
| Minor | 1.438 | 1.365 | 1.285 |
| Symptoms only | 1.693 | 2.350 | 1.705 |
The trial
How NCT00395746 was run
This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide in combination with sulphonylurea agent (SU) compared to SU monotherapy, as assessed by HbA1c after 24 weeks and 52 weeks in subjects with type 2 diabetes. Liraglutide will be compared to placebo, in combination with SU. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.
- 0.6 mg + SU: Liraglutide 0.6 mg + sulphonylurea
- 0.9 mg + SU: Liraglutide 0.9 mg + sulphonylurea
- SU Mono - 1: Liraglutide placebo 0.6 mg + sulphonylurea
- SU Mono - 2: Liraglutide placebo 0.9 mg + sulphonylurea
Who could join the trial
Inclusion Criteria: * Type 2 diabetes * Diet/exercise therapy with sulfonylurea (SU) for at least eight weeks * HbA1c greater than or equal to 7.0% and less than 10.0% * BMI less than 35 kg/m2 Exclusion Criteria: * Treatment with insulin within the last 12 weeks * Treatment with any drug that could interfere with the glucose level * Any serious medical condition * Females who are pregnant, have intention of becoming pregnant or are breastfeeding
Published papers
Papers from NCT00395746
- Seino Y, Rasmussen MF, Clauson P, Kaku K. The once-daily human glucagon-like peptide-1 analog, liraglutide, improves beta-cell function in Japanese patients with type 2 diabetes. J Diabetes Investig. 2012 Aug 20;3(4):388-95. doi: 10.1111/j.2040-1124.2012.00193.x.
- Kaku K, Rasmussen MF, Clauson P, Seino Y. Improved glycaemic control with minimal hypoglycaemia and no weight change with the once-daily human glucagon-like peptide-1 analogue liraglutide as add-on to sulphonylurea in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2010 Apr;12(4):341-7. doi: 10.1111/j.1463-1326.2009.01194.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.
- 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.
- Hegedus L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. doi: 10.1210/jc.2010-2318. Epub 2011 Jan 5.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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