- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00395746
Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes
January 25, 2017 updated by: Novo Nordisk A/S
Effect of Liraglutide in Combination With Sulfonylurea (SU) on Glycaemic Control in Subjects With Type 2 Diabetes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
264
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tokyo, Japan, 1000005
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0.6 mg + SU
Liraglutide 0.6 mg + sulphonylurea
|
SU agent
Liraglutide 0.6 mg/day or placebo.
Injected s.c.
(under the skin) once daily.
Liraglutide 0.9 mg/day or placebo.
Injected s.c.
(under the skin) once daily.
|
Experimental: 0.9 mg + SU
Liraglutide 0.9 mg + sulphonylurea
|
SU agent
Liraglutide 0.6 mg/day or placebo.
Injected s.c.
(under the skin) once daily.
Liraglutide 0.9 mg/day or placebo.
Injected s.c.
(under the skin) once daily.
|
Placebo Comparator: SU Mono - 1
Liraglutide placebo 0.6 mg + sulphonylurea
|
SU agent
|
Placebo Comparator: SU Mono - 2
Liraglutide placebo 0.9 mg + sulphonylurea
|
SU agent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
Time Frame: after 24 weeks of treatment
|
after 24 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
Time Frame: after 52 weeks of treatment
|
after 52 weeks of treatment
|
|
Fasting Plasma Glucose After 24 Weeks of Treatment
Time Frame: after 24 weeks of treatment
|
after 24 weeks of treatment
|
|
Fasting Plasma Glucose After 52 Weeks of Treatment
Time Frame: after 52 weeks of treatment
|
after 52 weeks of treatment
|
|
Postprandial Glucose AUC After 24 Weeks of Treatment
Time Frame: after 24 weeks of treatment
|
Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment
|
after 24 weeks of treatment
|
Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
Time Frame: after 24 weeks of treatment
|
Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment.
The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
|
after 24 weeks of treatment
|
Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
Time Frame: after 52 weeks of treatment
|
Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment.
The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
|
after 52 weeks of treatment
|
Body Weight After 24 Weeks of Treatment
Time Frame: after 24 weeks of treatment
|
after 24 weeks of treatment
|
|
Body Weight After 52 Weeks of Treatment
Time Frame: after 52 weeks of treatment
|
after 52 weeks of treatment
|
|
Hypoglycaemic Episodes
Time Frame: over 52 weeks of treatment
|
Hypoglycaemic episodes measured over 52 weeks of treatment.
Hypoglycaemic episodes were defined as major, minor, or symptoms only.
Major if the subject was unable to treat her/himself.
Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L.
Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
|
over 52 weeks of treatment
|
Postprandial Glucose AUC After 52 Weeks of Treatment
Time Frame: after 52 weeks of treatment
|
Postprandial Glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment
|
after 52 weeks of treatment
|
Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
Time Frame: after 24 weeks of treatment
|
Plasma glucose (PG) profile measured after 24 weeks of treatment.
The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
|
after 24 weeks of treatment
|
Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
Time Frame: after 52 weeks of treatment
|
7-point plasma glucose (PG) profile measured after 52 weeks of treatment.
The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.
|
after 52 weeks of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Diabetes Care. 2015 Aug;38(8):1622.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
November 2, 2006
First Submitted That Met QC Criteria
November 2, 2006
First Posted (Estimate)
November 3, 2006
Study Record Updates
Last Update Posted (Actual)
March 8, 2017
Last Update Submitted That Met QC Criteria
January 25, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN2211-1701
- JapicCTI-060324 (Registry Identifier: japic)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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