Status:
COMPLETED
Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of repaglinide plus metformin as initial treatment compared to repaglinide alone in Ch...
Eligibility Criteria
Inclusion
- Diagnosed with type 2 diabetes
- Never taken oral antidiabetic drugs before
- HbA1c greater than 8.5 %
- BMI (Body Mass Index) less than or equal to 35 kg/m\^2
Exclusion
- Known or suspected allergy to repaglinide, metformin, or any of the excipients in the medications
- Taken an investigational drug in another clinical trial within 4 weeks prior to this trial
- Impaired liver function, defined as ASAT (aspartate aminotransferase) or ALAT (alanine aminotransferase) equal to or greater than 2 times upper normal limit
- Have a clinically significant, active disease of the gastrointestinal, pulmonary, neurological, renal, genitourinary, and haematological systems
- Severe uncontrolled or untreated hypertension (sitting diastolic blood pressure (BP) equal to or greater than 100 mmHg or systolic BP equal to or greater than 180 mmHg)
- Impaired renal function
- Acute or chronic acidosis or if there are plans to have a radiographic material containing iodine
- Have a clinically significant, active cardiovascular disease, or decompensated heart failure
- Treatment with systemic corticosteroids within the past two months prior to screening
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
433 Patients enrolled
Trial Details
Trial ID
NCT00819741
Start Date
February 1 2009
End Date
November 1 2009
Last Update
February 10 2017
Active Locations (17)
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1
Novo Nordisk Investigational Site
Fuzhou, Fujian, China, 350001
2
Novo Nordisk Investigational Site
Nanjing, Jiangsu, China, 210009
3
Novo Nordisk Investigational Site
Nanjing, Jiangsu, China, 210012
4
Novo Nordisk Investigational Site
Nanjing, Jiangsu, China, 210029