Primary outcome
What NCT01847313 measured first
| Liraglutiden=9 | Controln=8 |
|---|---|
| 27.9(14.3) | 24.3(15.4) |
Phase 3 · Liraglutide
NCT01847313 trial results
Phase 3 Study of the Effect of Glucagon-like-peptide 1 (GLP-1) Receptor Agonism on Renal Outcomes in Humans With Diabetic Kidney Disease
MCP-1:Creatinine Ratio in Urine (ng/mmol), Up to 26 weeks. Liraglutide: 27.9; Control: 24.3.
- Participants
- 20
- Status
- completed
- Completed
- 2015-11
- Sponsor
- Karl Neff
As posted on ClinicalTrials.gov (NCT01847313), updated at source Feb 8, 2019. 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 NCT01847313
Percent of participants affected, Starting from the first administration of the IMP through to the End of Study Visit (30 weeks) all Adverse Event and Serious Adverse event information was collected at each visit.. The most common events the registry lists.
| Event | Liraglutide | Control |
|---|---|---|
| Any serious event | 10% | 10% |
| Hypokalaemia | 0% | 20% |
| Diarrhoea | 20% | 0% |
| Gastroenteritis | 20% | 0% |
| Hypoglycaemia | 20% | 10% |
| Acute kidney injury | 10% | 10% |
| Viral illness | 0% | 10% |
| Dyspepsia | 10% | 0% |
| Gastritis | 10% | 0% |
| Dizziness | 0% | 10% |
| Erectile dysfunction | 10% | 0% |
| Ingrown toenail | 0% | 10% |
| Upper respiratory tract infection | 0% | 10% |
| Palpitations | 0% | 10% |
| Mouth ulcer | 0% | 10% |
| Loose stool | 10% | 0% |
| Lower respiratory tract infection | 10% | 0% |
| Sinusitis | 10% | 0% |
| Hyponatraemia | 10% | 0% |
Secondary outcomes
What else it measured
| Liraglutiden=9 | Controln=7 |
|---|---|
| 144.1(232.6) | 132.4(101.3) |
| Liraglutiden=10 | Controln=8 |
|---|---|
| 82(34) | 84(23) |
| Liraglutiden=10 | Controln=8 |
|---|---|
| 27.9(14.0) | 24.3(15.4) |
The trial
How NCT01847313 was run
Diabetic kidney disease (DKD) is a devastating complication of diabetes, that in it's worst form, can lead to early cardiovascular death or kidney failure. A group of medicines used to treat diabetes, glucagon-like-peptide-1 analogues (GLP-1), may be able to protect people with diabetes from DKD by reducing inflammation in the kidney. This study aims to test this theory by studying the effect of GLP-1 on kidney function in people with diabetes. To understand how GLP-1 can affect inflammation, the investigators will give a GLP-1 treatment (Liraglutide) to people with DKD and monitor the effect on inflammation and kidney function using blood and urine tests. The investigators will compare these results to patients with DKD who do not receive GLP-1 treatment. If GLP-1 proves to be effective in reducing inflammation and improving kidney function, then it could be developed as a viable new treatment for people with DKD, and may significantly reduce the disease burden, or the risk of DKD, in people with diabetes. This would be a major advance in the treatment of DKD.
- Liraglutide: Liraglutide 0.6 mg daily
- Control: Standard diabetes care including renin angiotensin aldosterone system inhibitor or antagonist
Who could join the trial
Inclusion Criteria: * Type 2 diabetes with a HbA1c of 42-75mmol/mol (6-9%DCCT) * Male or female aged above 30 years * Have a negative pregnancy test at screening (women of child bearing potential only) * Body mass index (BMI) of 25kg/m2 or greater * On a renin-angiotensin system antagonist, at a stable dose, for at least 8 weeks before inclusion into the study * Established microalbuminuria * Estimated glomerular filtration rate (eGFR) 30ml/min/1.73m2 or above by Modification of Diet in Renal Disease (MDRD) formula Exclusion Criteria: * Patients with any cognitive impediment that preclude the patient from giving free and informed consent * Patients on dipeptidyl peptidase 4 inhibitors or thiazolidinedione treatment * Patients with stage 4-5 renal disease, defined as an eGFR of 30ml/min/1.73m2 or less * Patients who have used a GLP-1 agent in the last 6 months * Female patients of child bearing potential who are pregnant, breastfeeding, or unwilling to practice an acceptable barrier and/or hormonal method of contraception or abstinence during participation in the study * Previous pancreatitis * Hypersensitivity to GLP-1 analogues * Proliferative diabetic retinopathy * Any other contraindications, as per the SmPC for liraglutide * Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the dosing requirements * Concurrent treatment with an investigational drug or participation in another clinical trial * Use of an investigational drug within 4 weeks or 5 half-lives, whichever is longer, preceding the first dose of investigational medicinal product
Published papers
Papers from NCT01847313
- Fenske WK, Dubb S, Bueter M, Seyfried F, Patel K, Tam FW, Frankel AH, le Roux CW. Effect of bariatric surgery-induced weight loss on renal and systemic inflammation and blood pressure: a 12-month prospective study. Surg Obes Relat Dis. 2013 Jul-Aug;9(4):559-68. doi: 10.1016/j.soard.2012.03.009. Epub 2012 Apr 10.
- Miras AD, Chuah LL, Lascaratos G, Faruq S, Mohite AA, Shah PR, Gill M, Jackson SN, Johnston DG, Olbers T, le Roux CW. Bariatric surgery does not exacerbate and may be beneficial for the microvascular complications of type 2 diabetes. Diabetes Care. 2012 Dec;35(12):e81. doi: 10.2337/dc11-2353. No abstract available.
- Meguid El Nahas A, Bello AK. Chronic kidney disease: the global challenge. Lancet. 2005 Jan 22-28;365(9456):331-40. doi: 10.1016/S0140-6736(05)17789-7.
- Navarro-Gonzalez JF, Mora-Fernandez C, Muros de Fuentes M, Garcia-Perez J. Inflammatory molecules and pathways in the pathogenesis of diabetic nephropathy. Nat Rev Nephrol. 2011 Jun;7(6):327-40. doi: 10.1038/nrneph.2011.51. Epub 2011 May 3.
- Lim AK, Tesch GH. Inflammation in diabetic nephropathy. Mediators Inflamm. 2012;2012:146154. doi: 10.1155/2012/146154. Epub 2012 Aug 21.
- Shyangdan DS, Royle P, Clar C, Sharma P, Waugh N, Snaith A. Glucagon-like peptide analogues for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2011 Oct 5;2011(10):CD006423. doi: 10.1002/14651858.CD006423.pub2.
- Hogan AE, Tobin AM, Ahern T, Corrigan MA, Gaoatswe G, Jackson R, O'Reilly V, Lynch L, Doherty DG, Moynagh PN, Kirby B, O'Connell J, O'Shea D. Glucagon-like peptide-1 (GLP-1) and the regulation of human invariant natural killer T cells: lessons from obesity, diabetes and psoriasis. Diabetologia. 2011 Nov;54(11):2745-54. doi: 10.1007/s00125-011-2232-3. Epub 2011 Jul 9.
- Lynch LA, O'Connell JM, Kwasnik AK, Cawood TJ, O'Farrelly C, O'Shea DB. Are natural killer cells protecting the metabolically healthy obese patient? Obesity (Silver Spring). 2009 Mar;17(3):601-5. doi: 10.1038/oby.2008.565. Epub 2008 Dec 18.
- Lynch L, O'Shea D, Winter DC, Geoghegan J, Doherty DG, O'Farrelly C. Invariant NKT cells and CD1d(+) cells amass in human omentum and are depleted in patients with cancer and obesity. Eur J Immunol. 2009 Jul;39(7):1893-901. doi: 10.1002/eji.200939349.
- Chow FY, Nikolic-Paterson DJ, Ozols E, Atkins RC, Rollin BJ, Tesch GH. Monocyte chemoattractant protein-1 promotes the development of diabetic renal injury in streptozotocin-treated mice. Kidney Int. 2006 Jan;69(1):73-80. doi: 10.1038/sj.ki.5000014.
- Chow F, Ozols E, Nikolic-Paterson DJ, Atkins RC, Tesch GH. Macrophages in mouse type 2 diabetic nephropathy: correlation with diabetic state and progressive renal injury. Kidney Int. 2004 Jan;65(1):116-28. doi: 10.1111/j.1523-1755.2004.00367.x.
- Kanamori H, Matsubara T, Mima A, Sumi E, Nagai K, Takahashi T, Abe H, Iehara N, Fukatsu A, Okamoto H, Kita T, Doi T, Arai H. Inhibition of MCP-1/CCR2 pathway ameliorates the development of diabetic nephropathy. Biochem Biophys Res Commun. 2007 Sep 7;360(4):772-7. doi: 10.1016/j.bbrc.2007.06.148. Epub 2007 Jul 6.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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