Primary outcome
What NCT00393718 measured first
| Liraglutiden=263 | Glibenclamiden=130 |
|---|---|
| 6.99(0.07) | 7.50(0.09) |
Phase 3 · Liraglutide
NCT00393718 trial results
Effect of Liraglutide 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. Liraglutide: 6.99; Glibenclamide: 7.50.
- Participants
- 400
- Status
- completed
- Completed
- 2008-05
- Sponsor
- Novo Nordisk A/S
As posted on ClinicalTrials.gov (NCT00393718), 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 NCT00393718
Percent of participants affected, Adverse events were collected in a time span over 52 weeks.. The most common events the registry lists.
| Event | Liraglutide | Glibenclamide |
|---|---|---|
| Any serious event | 7.5% | 10.6% |
| Nasopharyngitis | 37.3% | 43.2% |
| Diarrhoea | 9.7% | 6.8% |
| Upper respiratory tract inflammation | 9.3% | 6.8% |
| Arthralgia | 3% | 8.3% |
| Constipation | 7.8% | 5.3% |
| Back pain | 6.3% | 6.8% |
| Diabetic retinopathy | 6% | 6.8% |
| Bronchitis | 4.1% | 6.1% |
| Headache | 5.6% | 4.5% |
| Pharyngolaryngeal pain | 0.7% | 5.3% |
| Hypertension | 4.1% | 5.3% |
| Stomach discomfort | 5.2% | 2.3% |
| Nausea | 5.2% | 1.5% |
Secondary outcomes
What else it measured
| Liraglutiden=263 | Glibenclamiden=130 |
|---|---|
| 7.31(0.08) | 7.80(0.10) |
| Liraglutiden=261 | Glibenclamiden=130 |
|---|---|
| 137.2(1.9) | 150.1(2.5) |
| Liraglutiden=261 | Glibenclamiden=130 |
|---|---|
| 145.8(2.4) | 157.5(3.2) |
| Liraglutiden=243 | Glibenclamiden=119 |
|---|---|
| 557.54(9.53) | 670.60(12.69) |
| Liraglutiden=228 | Glibenclamiden=112 |
|---|---|
| 608.66(11.18) | 683.17(14.96) |
| Liraglutiden=237 | Glibenclamiden=120 |
|---|---|
| 155.98(2.61) | 173.61(3.51) |
| Liraglutiden=237 | Glibenclamiden=119 |
|---|---|
| 167.39(3.22) | 184.60(4.34) |
| Liraglutiden=238 | Glibenclamiden=120 |
|---|---|
| 59.69(2.83) | 79.66(3.75) |
| Liraglutiden=238 | Glibenclamiden=119 |
|---|---|
| 63.56(2.96) | 76.59(3.94) |
| Liraglutiden=265 | Glibenclamiden=130 |
|---|---|
| 64.06(0.15) | 65.97(0.20) |
| Liraglutiden=265 | Glibenclamiden=130 |
|---|---|
| 64.30(0.19) | 66.01(0.25) |
| Measure | Liraglutiden=268 | Glibenclamiden=132 |
|---|---|---|
| All hypoglycaemic episodes | 0.694 | 3.843 |
| Major | 0.000 | 0.000 |
| Minor | 0.187 | 1.103 |
| Symptoms only | 0.507 | 2.740 |
The trial
How NCT00393718 was run
This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide, compared to sulfonylurea (SU treatment), as assessed by HbA1c after 24 and 52 weeks in subjects with type 2 diabetes. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.
- Liraglutide: Liraglutide 0.9 mg + glibenclamide placebo
- Glibenclamide: Glibenclamide 1.25-2.5 mg + liraglutide placebo
Who could join the trial
Inclusion Criteria: * Type 2 diabetes * Diet/exercise therapy with or without an oral anti-diabetic drug for at least eight weeks * HbA1c greater than or equal to 7.0% and less than 10.0% * BMI (Body Mass Index) 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 NCT00393718
- Seino Y, Rasmussen MF, Nishida T, Kaku K. Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes. Curr Med Res Opin. 2010 May;26(5):1013-22. doi: 10.1185/03007991003672551.
- 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.
- 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.
- 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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