Primary outcome
What NCT01722266 measured first
| Placebon=17 | Liraglutide 1.8mgn=15 | Liraglutide 1.2mgn=13 | Liraglutide 0.6 mgn=18 |
|---|---|---|---|
| 1(0) | -10(1) | -10(2) | -0.3(2) |
Phase 3 · Liraglutide
NCT01722266 trial results
Liraglutide in the Treatment of Type 1 Diabetes Mellitus
Change in Mean Weekly Glucose Concentrations (mg/dl), 12 Weeks. Placebo: 1; Liraglutide 1.8mg: -10; Liraglutide 1.2mg: -10; Liraglutide 0.6 mg: -0.3.
- Participants
- 72
- Status
- completed
- Completed
- 2014-12-01
- Sponsor
- University at Buffalo
As posted on ClinicalTrials.gov (NCT01722266), updated at source Jan 5, 2024. 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 NCT01722266
Percent of participants affected, 12 weeks.. The most common events the registry lists.
| Event | Placebo | Liraglutide 1.8mg | Liraglutide 1.2mg | Liraglutide 0.6 mg |
|---|---|---|---|---|
| Any serious event | 0% | 0% | 0% | 0% |
| Transient Nausea | 17.6% | 60% | 76.9% | 61.1% |
Secondary outcomes
What else it measured
| Placebon=17 | Liraglutide 1.8mgn=15 | Liraglutide 1.2mgn=13 | Liraglutide 0.6 mgn=18 |
|---|---|---|---|
| -0.30(0.15) | -0.42(0.15) | -0.78(0.15) | -0.26(0.17) |
| Placebon=17 | Liraglutide 1.8mgn=15 | Liraglutide 1.2mgn=13 | Liraglutide 0.6 mgn=18 |
|---|---|---|---|
| -0.3(0.5) | -4.8(0.7) | -5.0(1.2) | -2.7(0.6) |
| Placebon=17 | Liraglutide 1.8mgn=15 | Liraglutide 1.2mgn=13 | Liraglutide 0.6 mgn=18 |
|---|---|---|---|
| -3.4(0.7) | -10(0.5) | -12.1(0.7) | -2.8(0.7) |
| Placebon=17 | Liraglutide 1.8mgn=15 | Liraglutide 1.2mgn=13 | Liraglutide 0.6 mgn=18 |
|---|---|---|---|
| 0.04(0) | -0.55(10) | -0.55(10) | -0.01(0.11) |
| Placebon=17 | Liraglutide 1.8mgn=15 | Liraglutide 1.2mgn=13 | Liraglutide 0.6 mgn=18 |
|---|---|---|---|
| -13.4(2.6) | -46.4(1.6) | -47.6(2.6) | -23.7(2.5) |
| Placebon=17 | Liraglutide 1.8mgn=15 | Liraglutide 1.2mgn=13 | Liraglutide 0.6 mgn=18 |
|---|---|---|---|
| 5(3) | 9(6) | -6(9) | 7(4) |
The trial
How NCT01722266 was run
Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases fasting, postprandial and the overall mean glucose concentrations. Aim 1.1: To compare the mean fasting, the mean weekly glucose and the standard deviation of weekly blood glucose concentrations as recorded by continuous glucose monitoring prior to and following 6 weeks and 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. In addition, the time spent at glucose concentrations \>150 and 200mg/dl and \<70 and \<40 mg/dl will also be compared. Aim 1.2: To compare the postprandial glucose concentrations following a test meal before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. Glucose concentrations will be measured as areas under the curve for the data obtained from the meal challenge. Aim 1.3: To compare HbA1c levels(glycated hemoglobin) before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases postprandial glucagon concentrations and increases postprandial C-peptide concentrations. Aim 2.1: To compare fasting and postprandial glucagon and C-peptide concentrations following a test meal before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric emptying. Aim 3.1: To compare the gastric emptying as measured by acetaminophen absorption before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily.
- Placebo: Daily Injection
- Liraglutide 1.8mg: Daily Injection
- Liraglutide 1.2mg: Daily injections
- Liraglutide 0.6 mg: Daily injection
Who could join the trial
Inclusion Criteria: 1. Patients with type 1 diabetes mellitus: Fasting c-peptide \< 0.1nmol/l on insulin therapy for more than 12 months with or without history of diabetic ketoacidosis. 2. Using a continuous glucose monitoring device (CGM) and regularly measuring their blood sugars four times daily 3. HbA1c of less than 8.5%. 4. Well versed with carbohydrate counting 5. Age 18-75 years Exclusion Criteria: 1. Type 1 diabetes for less than 12 months; 2. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 3. Hepatic disease (transaminase \> 3 times normal) or cirrhosis; 4. Renal impairment (serum creatinine \> 1.5); 5. HIV or Hepatitis C positive status; 6. Participation in any other concurrent clinical trial; 7. Any other life-threatening, non-cardiac disease; 8. Use of an investigational agent or therapeutic regimen within 30 days of study. 9. history of pancreatitis 10. pregnancy 11. inability to give informed consent 12. history of gastroparesis 13. history of medullary thyroid carcinoma or MEN 2 syndrome. 14. Family history of MEN 2, Family history of medullary thyroid cancer, or familial medullary thyroid cancer 15. Women of childbearing potential who are not using adequate contraception 16) Women who are pregnant
Published papers
Papers from NCT01722266
- Kuhadiya ND, Malik R, Bellini NJ, Patterson JL, Traina A, Makdissi A, Dandona P. Liraglutide as additional treatment to insulin in obese patients with type 1 diabetes mellitus. Endocr Pract. 2013 Nov-Dec;19(6):963-7. doi: 10.4158/EP13065.OR.
- Varanasi A, Bellini N, Rawal D, Vora M, Makdissi A, Dhindsa S, Chaudhuri A, Dandona P. Liraglutide as additional treatment for type 1 diabetes. Eur J Endocrinol. 2011 Jul;165(1):77-84. doi: 10.1530/EJE-11-0330. Epub 2011 Jun 6.
- Kielgast U, Asmar M, Madsbad S, Holst JJ. Effect of glucagon-like peptide-1 on alpha- and beta-cell function in C-peptide-negative type 1 diabetic patients. J Clin Endocrinol Metab. 2010 May;95(5):2492-6. doi: 10.1210/jc.2009-2440. Epub 2010 Mar 5.
- Rother KI, Spain LM, Wesley RA, Digon BJ 3rd, Baron A, Chen K, Nelson P, Dosch HM, Palmer JP, Brooks-Worrell B, Ring M, Harlan DM. Effects of exenatide alone and in combination with daclizumab on beta-cell function in long-standing type 1 diabetes. Diabetes Care. 2009 Dec;32(12):2251-7. doi: 10.2337/dc09-0773. Epub 2009 Oct 6.
- Ghanim H, Aljada A, Daoud N, Deopurkar R, Chaudhuri A, Dandona P. Role of inflammatory mediators in the suppression of insulin receptor phosphorylation in circulating mononuclear cells of obese subjects. Diabetologia. 2007 Feb;50(2):278-85. doi: 10.1007/s00125-006-0508-9. Epub 2006 Dec 16.
- Wajchenberg BL, Feitosa AC, Rassi N, Lerario AC, Betti RT. Glycemia and cardiovascular disease in type 1 diabetes mellitus. Endocr Pract. 2008 Oct;14(7):912-23. doi: 10.4158/EP.14.7.912.
- Buse JB, Klonoff DC, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Maggs DG, Wintle ME. Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials. Clin Ther. 2007 Jan;29(1):139-53. doi: 10.1016/j.clinthera.2007.01.015.
- Montanya E, Sesti G. A review of efficacy and safety data regarding the use of liraglutide, a once-daily human glucagon-like peptide 1 analogue, in the treatment of type 2 diabetes mellitus. Clin Ther. 2009 Nov;31(11):2472-88. doi: 10.1016/j.clinthera.2009.11.034.
- Varanasi A, Patel P, Makdissi A, Dhindsa S, Chaudhuri A, Dandona P. Clinical use of liraglutide in type 2 diabetes and its effects on cardiovascular risk factors. Endocr Pract. 2012 Mar-Apr;18(2):140-5. doi: 10.4158/EP11169.OR.
- Varanasi A, Chaudhuri A, Dhindsa S, Arora A, Lohano T, Vora MR, Dandona P. Durability of effects of exenatide treatment on glycemic control, body weight, systolic blood pressure, C-reactive protein, and triglyceride concentrations. Endocr Pract. 2011 Mar-Apr;17(2):192-200. doi: 10.4158/EP10199.OR.
- Okerson T, Yan P, Stonehouse A, Brodows R. Effects of exenatide on systolic blood pressure in subjects with type 2 diabetes. Am J Hypertens. 2010 Mar;23(3):334-9. doi: 10.1038/ajh.2009.245. Epub 2009 Dec 17.
- Lebovitz HE. Adjunct therapy for type 1 diabetes mellitus. Nat Rev Endocrinol. 2010 Jun;6(6):326-34. doi: 10.1038/nrendo.2010.49. Epub 2010 Apr 20.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.