We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Liraglutide or Glimepiride Added to Metformin 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: NCT00614120
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : March 12, 2010
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: placebo Drug: glimepiride Drug: metformin Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 929 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes
Study Start Date : January 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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/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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00614120


Locations
Show Show 50 study locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Layout table for investigator information
Study Director: Global Clinical Registry (GCR, 1452), MD, PhD Novo Nordisk A/S
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

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

Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00614120    
Other Study ID Numbers: NN2211-1796
First Posted: February 13, 2008    Key Record Dates
Results First Posted: March 12, 2010
Last Update Posted: March 8, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Liraglutide
Glimepiride
 Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors