Clinical trial NCT00395746: Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes
Official title: Effect of Liraglutide in Combination With Sulfonylurea (SU) on Glycaemic Control in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2006-11-03
Enrollment: 264
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
timeFrame: after 24 weeks of treatment
Secondary outcomes:
measure: Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
timeFrame: after 52 weeks of treatment
measure: Fasting Plasma Glucose After 24 Weeks of Treatment
timeFrame: after 24 weeks of treatment
measure: Fasting Plasma Glucose After 52 Weeks of Treatment
timeFrame: after 52 weeks of treatment
measure: Postprandial Glucose AUC After 24 Weeks of Treatment
timeFrame: after 24 weeks of treatment
measure: Postprandial Glucose AUC After 52 Weeks of Treatment
timeFrame: after 52 weeks of treatment
measure: Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
timeFrame: after 24 weeks of treatment
measure: Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
timeFrame: after 52 weeks of treatment
measure: Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
timeFrame: after 24 weeks of treatment
measure: Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
timeFrame: after 52 weeks of treatment
measure: Body Weight After 24 Weeks of Treatment
timeFrame: after 24 weeks of treatment
measure: Body Weight After 52 Weeks of Treatment
timeFrame: after 52 weeks of treatment
measure: Hypoglycaemic Episodes
timeFrame: over 52 weeks of treatment
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.