Effect of Liraglutide or Glimepiride Added to Metformin 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:
NCT00614120
First received: January 15, 2008
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide
Drug: placebo
Drug: glimepiride
Drug: metformin
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 or Glimepiride Added to Metformin 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:
  • Change in Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: week 0, week 16 ] [ Designated as safety issue: No ]
    Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).


Secondary Outcome Measures:
  • Change in Body Weight [ Time Frame: week 0, week 16 ] [ Designated as safety issue: No ]
    Change in body weight from baseline (week 0) to 16 weeks (end of treatment)

  • Change in Self-measured Fasting Plasma Glucose [ Time Frame: week 0, week 16 ] [ Designated as safety issue: No ]
    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.

  • 7-point Self-measured Plasma Glucose Profiles [ Time Frame: week 0, 8, 12 and 16 ] [ Designated as safety issue: No ]
    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).

  • Change in Beta-cell Function [ Time Frame: week 0, week 16 ] [ Designated as safety issue: No ]

    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).


  • Change in Fasting Lipid Profile [ Time Frame: week 0, week 16 ] [ Designated as safety issue: No ]

    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)

  • Change in Fasting Lipid Profile, APO-B [ Time Frame: week 0, week 16 ] [ Designated as safety issue: No ]
    Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment).

  • Hypoglycaemic Episodes [ Time Frame: weeks 0-16 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 929
Study Start Date: January 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lira 0.6 + Met
Liraglutide 0.6 mg + metformin + glimepiride placebo
Drug: liraglutide
0.6 mg/day, s.c. (under the skin) injection
Drug: placebo
Glimepiride placebo, capsules
Drug: metformin
Tablets, 1.5-2.0 g/day
Experimental: Lira 1.2 + Met
Liraglutide 1.2 mg + metformin + glimepiride placebo
Drug: placebo
Glimepiride placebo, capsules
Drug: liraglutide
1.2 mg/day, s.c. (under the skin) injection
Drug: metformin
Tablets, 1.5-2.0 g/day
Experimental: Lira 1.8 + Met
Liraglutide + metformin + glimepiride placebo
Drug: placebo
Glimepiride placebo, capsules
Drug: liraglutide
1.8 mg/day, s.c. (under the skin) injection
Drug: metformin
Tablets, 1.5-2.0 g/day
Experimental: Glim + Met
Glimepiride 4.0 mg + metformin + liraglutide placebo
Drug: glimepiride
Capsules, 4.0 mg/day
Drug: metformin
Tablets, 1.5-2.0 g/day
Drug: placebo
Liraglutide placebo, s.c. (under the skin) injection

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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/m2

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614120

Locations
China, Beijing
Beijing, Beijing, China, 100029
India
Hyderabad, India, 500 001
Korea, Republic of
Sungnam, Korea, Republic of, 463-707
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Marcin Zychma, MD, PhD Novo Nordisk A/S
  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: NCT00614120     History of Changes
Other Study ID Numbers: NN2211-1796
Study First Received: January 15, 2008
Results First Received: February 23, 2010
Last Updated: June 19, 2012
Health Authority: China: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
India: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Metformin
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on April 16, 2014