DiabetesPhase 3NCT00393718

Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

A Phase 3 study testing liraglutide and glibenclamide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: liraglutide and glibenclamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 400 participants
Where: 1 siteJapan
Study dates: Nov 2006to May 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Novo Nordisk Investigational Site
Tokyo, 1000005

Other trials in Japan

About this study

Official title: Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: liraglutide, glibenclamide, placebo
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

liraglutideDrug
0.9 mg/day. Injected s.c. (under the skin) once daily.
glibenclamideDrug
1.25-2.5 mg tablet. Given orally once or twice daily.
placeboDrug
liraglutide placebo. Injected s.c. (under the skin) once daily.
placeboDrug
glibenclamide placebo. Given orally once or twice daily.

Study groups in NCT00393718
Study group	Role	What they receive
Liraglutide	Experimental	Liraglutide 0.9 mg + glibenclamide placebo Receives: Drug: liraglutide; Drug: placebo
Glibenclamide	Active comparator	Glibenclamide 1.25-2.5 mg + liraglutide placebo Receives: Drug: glibenclamide; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
Measured: after 24 weeks of treatment

Secondary outcomes (12)

Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
Measured: after 52 weeks of treatment
Fasting Plasma Glucose After 24 Weeks of Treatment
Measured: after 24 weeks of treatment
Fasting Plasma Glucose After 52 Weeks of Treatment
Measured: after 52 weeks of treatment
Postprandial Glucose AUC After 24 Weeks of Treatment
Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment
Measured: after 24 weeks of treatment
Postprandial Glucose AUC After 52 Weeks of Treatment
Postprandial glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment
Measured: after 52 weeks of treatment
Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment
Plasma glucose (PG) profile measured after 24 weeks of treatment. The 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.
Measured: after 24 weeks of treatment
Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
Mean plasma glucose(PG) in 7-point plasma glucose 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.
Measured: after 52 weeks of treatment
Mean Postprandial PG Increment in 7-point Plasma Glucose Profile 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.
Measured: after 24 weeks of treatment
Mean Postprandial PG Increment in 7-point Plasma Glucose Profile 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.
Measured: after 52 weeks of treatment
Body Weight After 24 Weeks of Treatment
Measured: after 24 weeks of treatment
Body Weight After 52 Weeks of Treatment
Measured: after 52 weeks of treatment
Hypoglycaemic Episodes
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.
Measured: over 52 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2006May 2008

First posted30 Oct 2006 (estimated)
Study startNov 2006
Primary completionNov 2007
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00393718
Sponsor's protocol ID: NN2211-1700
Status last verified: Jan 2017
First submitted: 27 Oct 2006
Last updated: 8 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 20199137
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.
PubMed 24843595
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.
PubMed 23010561
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.
PubMed 21209033

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00393718
Acronym / sponsor ID: NN2211-1700
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Nov 2007 (actual)
Study completion: May 2008 (actual)
First posted: 30 Oct 2006 (estimated)
Results: Posted 12 Mar 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Liraglutide	Experimental	Drug: liraglutide, Drug: placeboLiraglutide 0.9 mg + glibenclamide placebo
Glibenclamide	Active comparator	Drug: glibenclamide, Drug: placeboGlibenclamide 1.25-2.5 mg + liraglutide placebo

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
liraglutide0.9 mg/day. Injected s.c. (under the skin) once daily.	Drug	Liraglutide
glibenclamide1.25-2.5 mg tablet. Given orally once or twice daily.	Drug	Glibenclamide
placeboliraglutide placebo. Injected s.c. (under the skin) once daily.	Drug	Glibenclamide
placeboglibenclamide placebo. Given orally once or twice daily.	Drug	Liraglutide

Primary outcome

Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment
Time frame: after 24 weeks of treatment

12 secondary outcomes

Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment
Time frame: after 52 weeks of treatment
Fasting Plasma Glucose After 24 Weeks of Treatment
Time frame: after 24 weeks of treatment
Fasting Plasma Glucose After 52 Weeks of Treatment
Time frame: after 52 weeks of treatment
Postprandial Glucose AUC After 24 Weeks of Treatment
Time frame: after 24 weeks of treatment
Postprandial Glucose AUC After 52 Weeks of Treatment
Time frame: 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
Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
Time frame: after 52 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 PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment
Time frame: after 52 weeks of treatment
Body Weight After 24 Weeks of Treatment
Time frame: after 24 weeks of treatment
Body Weight After 52 Weeks of Treatment
Time frame: after 52 weeks of treatment
Hypoglycaemic Episodes
Time frame: over 52 weeks of treatment

Results and safety

Results posted to the registry on 12 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liraglutide	268	225
Glibenclamide	132	110

Primary outcome: Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment

Time frame: after 24 weeks of treatment. Least squares mean (Standard Error). Unit: percentage of total haemoglobin

Measure	Liraglutide n = 263	Glibenclamide n = 130
Value	6.99 (0.07)	7.50 (0.09)

Liraglutide vs Glibenclamide: Least Squares Mean: -0.50 (95% CI -0.70 to -0.30), p <0.0001, ANOVA

Population analysed: Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected in a time span over 52 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liraglutide	20 of 268 (7.5%)	172 of 268 (64.2%)	Not reported
Glibenclamide	14 of 132 (10.6%)	91 of 132 (68.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20199137Seino 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.
Results publication: PubMed 24843595Seino 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.
Results publication: PubMed 23010561Alves 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.
Derived from this study: PubMed 21209033Hegedus 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.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing liraglutide and glibenclamide in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment (time frame: after 24 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00393718, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.