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Completed

NCT Number: NCT00614120

Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes

This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes

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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

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months
  • HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone
  • HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy
  • BMI less than 45.0 kg/m^2

Exclusion criteria

  • Treatment with insulin within the last 3 months prior to the trial
  • Impaired liver or/and renal function
  • Significant cardiovascular disease over the last 6 months
  • Known retinopathy or maculopathy
  • Recurrent major hypoglycaemia or hypoglycaemic unawareness

Treatment and study plan

liraglutide

Drug

0.6 mg/day, s.c. (under the skin) injection

Placebo

Drug

Glimepiride placebo, capsules

Glimepiride

Drug

Capsules, 4.0 mg/day

metformin

Drug

Tablets, 1.5-2.0 g/day

Primary outcomes

  1. Change in Glycosylated Haemoglobin A1c (HbA1c)

    Time frame: week 0, week 16

    Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).

Secondary outcomes

  1. Change in Body Weight

    Time frame: week 0, week 16

    Change in body weight from baseline (week 0) to 16 weeks (end of treatment)

  2. Change in Self-measured Fasting Plasma Glucose

    Time frame: week 0, week 16

    Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary.

  3. 7-point Self-measured Plasma Glucose Profiles

    Time frame: week 0, 8, 12 and 16

    Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16).

  4. Change in Beta-cell Function

    Time frame: week 0, week 16

    Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

    Beta-cell function: HOMA-B (%) = 20∙fasting insulin[uU/mL] divided by (FPG mmol/L]-3.5).

  5. Change in Fasting Lipid Profile

    Time frame: week 0, week 16

    Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on:

    • Total Cholesterol (TC)
    • Low-density Lipoprotein-cholesterol (LDL-C)
    • Very Low-density Lipoprotein-cholesterol (VLDL-C)
    • High-density Lipoprotein-cholesterol (HDL-C)
    • Triglyceride (TG)
    • Free Fatty Acid (FFA)

  6. Change in Fasting Lipid Profile, APO-B

    Time frame: week 0, week 16

    Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment).

  7. Hypoglycaemic Episodes

    Time frame: weeks 0-16

    Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). 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 or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 13, 2008
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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