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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00395746
First received: November 2, 2006
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: sulfonylurea
Drug: liraglutide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Liraglutide in Combination With Sulfonylurea (SU) on Glycaemic Control in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
  • Postprandial Glucose AUC After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
    Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment

  • Postprandial Glucose AUC After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
    Postprandial Glucose AUC measured 0-3 hours after a meal 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 ] [ Designated as safety issue: No ]
    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.

  • Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
    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.

  • Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
    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.

  • Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
    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.

  • Body Weight After 24 Weeks of Treatment [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]
  • Body Weight After 52 Weeks of Treatment [ Time Frame: after 52 weeks of treatment ] [ Designated as safety issue: No ]
  • Hypoglycaemic Episodes [ Time Frame: over 52 weeks of treatment ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 264
Study Start Date: October 2006
Study Completion Date: May 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395746

Locations
Japan
Osaka, Japan
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Yasuyuki Katayama, MD Novo Nordisk Pharma Ltd.
Study Director: Hiroko Terano Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00395746     History of Changes
Other Study ID Numbers: NN2211-1701, JapicCTI-060324
Study First Received: November 2, 2006
Results First Received: February 23, 2010
Last Updated: June 19, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014