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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00393718 (opens ClinicalTrials.gov in a new tab)Other idNN2211-1700
Open at ClinicalTrials.govAsk about this trial

Overview

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

Japan

Start
Nov 2006
Primary completion
Nov 2007
Completion
May 2008
First posted
30 Oct 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 on Blood Glucose Control in Subjects With Type 2 Diabetes

    NCT00393718

    Nov 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, compared to sulfonylurea (SU treatment), as assessed by HbA1c after 24 and 52 weeks in subjects with type 2 diabetes. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.

Interventions

  • liraglutideDrug
  • glibenclamideDrug
  • placeboDrug
  • placeboDrug

Arms2

  • Experimental

    Liraglutide

    Liraglutide 0.9 mg + glibenclamide placebo

  • Active comparator

    Glibenclamide

    Glibenclamide 1.25-2.5 mg + liraglutide placebo

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 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

    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.

  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
Liraglutide6.990.07
Glibenclamide7.500.09
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
Liraglutide7.310.08
Glibenclamide7.800.10
Secondary outcomeLeast squares mean· after 24 weeks of treatment

Fasting Plasma Glucose After 24 Weeks of Treatment

GroupValue (mg/dL)Spread
Liraglutide137.21.9
Glibenclamide150.12.5
Secondary outcomeLeast squares mean· after 52 weeks of treatment

Fasting Plasma Glucose After 52 Weeks of Treatment

GroupValue (mg/dL)Spread
Liraglutide145.82.4
Glibenclamide157.53.2
Secondary outcomeLeast squares mean· after 24 weeks of treatment

Postprandial Glucose AUC After 24 Weeks of Treatment

GroupValue (mg/dL *h)Spread
Liraglutide557.549.53
Glibenclamide670.6012.69
Secondary outcomeLeast squares mean· after 52 weeks of treatment

Postprandial Glucose AUC After 52 Weeks of Treatment

GroupValue (mg/dL *h)Spread
Liraglutide608.6611.18
Glibenclamide683.1714.96
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
Liraglutide155.982.61
Glibenclamide173.613.51
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
Liraglutide167.393.22
Glibenclamide184.604.34

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
LiraglutideLiraglutide 0.9 mg + glibenclamide placebo–20 / 268172 / 268
GlibenclamideGlibenclamide 1.25-2.5 mg + liraglutide placebo–14 / 13291 / 132

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

Studies4

Studies that cite this trial.

Studies with results

3 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: Randomized controlled trial · 2010

8 results

Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes.

Seino et al. 2010Current medical research and opinioncited by 91

PMID 20199137DOI 10.1185/03007991003672551PUB-20199137

Full text at the publisher8 results
Publisher pageSee results (8)

More studies

1 study on this page

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 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 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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