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Completed

NCT Number: NCT00395746

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulfonylurea

Drug

SU agent

liraglutide

Drug

Liraglutide 0.6 mg/day or placebo. Injected s.c. (under the skin) once daily.

Primary outcomes

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

    Time frame: after 24 weeks of treatment

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Nov 3, 2006
Registry last updated
Mar 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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