Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: liraglutide (Drug); placebo (Drug); liraglutide (Drug); liraglutide (Drug); glimepiride (Drug); metformin (Drug); placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Marcin Zychma, MD, PhD, Study Director, Affiliation: Novo Nordisk A/S
Overall contact:
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
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
Clinical Details
Official title: Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in HbA1c
Secondary outcome: Body weightFasting blood glucose 7-point plasma glucose profiles (self-measured) Beta-cell function and lipid profile Hyperglycaemic episodes and adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
Hyderabad, India; Recruiting
Sungnam, Korea, Republic of; Recruiting
Additional Information
Clinical Trials at Novo Nordisk
Starting date: January 2008
Ending date: January 2009
Last updated: February 12, 2008
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