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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes

NCTNCT00395746 (opens ClinicalTrials.gov in a new tab)Other idNN2211-1701Other idJapicCTI-060324
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
264 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

Japan

Start
Oct 2006
Primary completion
Oct 2007
Completion
May 2008
First posted
3 Nov 2006 (estimated)
Last update posted
8 Mar 2017
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200720082009
  1. Ph 3

    Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes

    NCT00395746

    Oct 2006 to May 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • sulfonylureaDrug
  • liraglutideDrug
  • liraglutideDrug

Arms4

  • Experimental

    0.6 mg + SU

    Liraglutide 0.6 mg + sulphonylurea

  • Experimental

    0.9 mg + SU

    Liraglutide 0.9 mg + sulphonylurea

  • Placebo comparator

    SU Mono - 1

    Liraglutide placebo 0.6 mg + sulphonylurea

  • Placebo comparator

    SU Mono - 2

    Liraglutide placebo 0.9 mg + sulphonylurea

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment

    Time frame · after 24 weeks of treatment

Secondary outcomes(12)

  1. Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment

    Time frame · after 52 weeks of treatment

  2. Fasting Plasma Glucose After 24 Weeks of Treatment

    Time frame · after 24 weeks of treatment

  3. Fasting Plasma Glucose After 52 Weeks of Treatment

    Time frame · after 52 weeks of treatment

  4. Postprandial Glucose AUC After 24 Weeks of Treatment

    Time frame · after 24 weeks of treatment

    Registry description

    Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment

  5. Postprandial Glucose AUC After 52 Weeks of Treatment

    Time frame · after 52 weeks of treatment

    Registry description

    Postprandial Glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment

  6. Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment

    Time frame · after 24 weeks of treatment

    Registry description

    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.

  7. Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment

    Time frame · after 52 weeks of treatment

    Registry description

    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.

  8. Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment

    Time frame · after 24 weeks of treatment

    Registry description

    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.

  9. Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment

    Time frame · after 52 weeks of treatment

    Registry description

    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.

  10. Body Weight After 24 Weeks of Treatment

    Time frame · after 24 weeks of treatment

  11. Body Weight After 52 Weeks of Treatment

    Time frame · after 52 weeks of treatment

  12. Hypoglycaemic Episodes

    Time frame · over 52 weeks of treatment

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· after 24 weeks of treatment

Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment

GroupValue (percentage of total haemoglobin)Spread
0.6 mg + SU7.020.10
0.9 mg + SU6.750.11
SU Mono8.020.10
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· after 52 weeks of treatment

Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment

GroupValue (percentage of total haemoglobin)Spread
0.6 mg + SU7.420.12
0.9 mg + SU7.060.13
SU Mono8.390.12
Secondary outcomeLeast squares mean· after 24 weeks of treatment

Fasting Plasma Glucose After 24 Weeks of Treatment

GroupValue (mg/dL)Spread
0.6 mg + SU132.23.5
0.9 mg + SU126.23.5
SU Mono158.83.5
Secondary outcomeLeast squares mean· after 52 weeks of treatment

Fasting Plasma Glucose After 52 Weeks of Treatment

GroupValue (mg/dL)Spread
0.6 mg + SU140.34.0
0.9 mg + SU134.54.1
SU Mono164.64.0
Secondary outcomeLeast squares mean· after 24 weeks of treatment

Postprandial Glucose AUC After 24 Weeks of Treatment

GroupValue (mg/dL *h)Spread
0.6 mg + SU614.5814.75
0.9 mg + SU575.5015.01
SU Mono725.7215.71
Secondary outcomeLeast squares mean· after 52 weeks of treatment

Postprandial Glucose AUC After 52 Weeks of Treatment

GroupValue (mg/dL *h)Spread
0.6 mg + SU648.8716.09
0.9 mg + SU589.9816.17
SU Mono717.5517.08
Secondary outcomeLeast squares mean· after 24 weeks of treatment

Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment

GroupValue (mg/dL)Spread
0.6 mg + SU160.204.44
0.9 mg + SU150.054.56
SU Mono194.504.61
Secondary outcomeLeast squares mean· after 52 weeks of treatment

Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment

GroupValue (mg/dL)Spread
0.6 mg + SU171.425.11
0.9 mg + SU159.585.30
SU Mono205.925.25

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
0.6 mg + SULiraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment–4 / 8868 / 88
0.9 mg + SULiraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment–3 / 8868 / 88
SU MonoLiraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment–5 / 8859 / 88

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies6

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Meta-analysis (pooled) · 2012

3 results

A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer.

Alves et al. 2012Diabetes research and clinical practicecited by 142

PMID 23010561DOI 10.1016/j.diabres.2012.09.008PUB-23010561

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Randomized controlled trial · 2011

3 results

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.

Hegedüs et al. 2011The Journal of clinical endocrinology and metabolismcited by 150

PMID 21209033DOI 10.1210/jc.2010-2318PUB-21209033

Rights unknown3 results
Source linkSee results (3)

Indexing hint: Clinical trial · 2011

6 results

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.

Buse et al. 2011The Journal of clinical endocrinology and metabolismcited by 116

PMID 21450987DOI 10.1210/jc.2010-2822PUB-21450987

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2010

11 results

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.

Kaku et al. 2010Diabetes, obesity & metabolismcited by 73

PMID 20380655DOI 10.1111/j.1463-1326.2009.01194.xPUB-20380655

Full text at the publisher11 results
Publisher pageSee results (11)

More studies

2 studies on this page

Indexing hint: Meta-analysis (pooled) · 2015

Corrected

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.

Jensen et al. 2015Diabetes carecited by 45

PMID 25504028DOI 10.2337/dc13-1210PUB-25504028

Rights unknown
Source linkRead the notice

PubMed tag: none · 2012

The once-daily human glucagon-like peptide-1 analog, liraglutide, improves β-cell function in Japanese patients with type 2 diabetes.

Seino et al. 2012Journal of diabetes investigationcited by 14

PMID 24843595PMC4019260DOI 10.1111/j.2040-1124.2012.00193.xPUB-24843595

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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