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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00395746
Recruitment Status : Completed
First Posted : November 3, 2006
Results First Posted : March 12, 2010
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: sulfonylurea Drug: liraglutide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Liraglutide in Combination With Sulfonylurea (SU) on Glycaemic Control in Subjects With Type 2 Diabetes
Study Start Date : October 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: 0.6 mg + SU
Liraglutide 0.6 mg + sulphonylurea
 Drug: sulfonylurea
SU agent

Drug: liraglutide
Liraglutide 0.6 mg/day or placebo. Injected s.c. (under the skin) once daily.
Experimental: 0.9 mg + SU
Liraglutide 0.9 mg + sulphonylurea
 Drug: sulfonylurea
SU agent

Drug: liraglutide
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
 Drug: sulfonylurea
SU agent
Placebo Comparator: SU Mono - 2
Liraglutide placebo 0.9 mg + sulphonylurea
 Drug: sulfonylurea
SU agent


Outcome Measures
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Primary Outcome Measures :
  1. Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ]

Secondary Outcome Measures :
  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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395746


Locations
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Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00395746    
Other Study ID Numbers: NN2211-1701
JapicCTI-060324 ( Registry Identifier: japic )
First Posted: November 3, 2006    Key Record Dates
Results First Posted: March 12, 2010
Last Update Posted: March 8, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
 Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists