Status:
COMPLETED
Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This trial is conducted in Asia. The aim of this trial is to compare the glycaemic control when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified treatment if treatme...
Eligibility Criteria
Inclusion
- Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1
- HbA1c at least 7.0 % - maximum 11 % at screening
- Subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)
- An antidiabetic regimen that has been stable for at least 3 months prior to screening
- An antidiabetic regimen that includes a minimum of 2 OADs
- OADs dosed at least 50% of the maximum recommended dose
Exclusion
- Known or suspected hypersensitivity to trial product(s) or related products
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
- The receipt of any investigational medicinal product within one month prior to this trial
- Suffer from a life threatening disease (cancer)
- Cardiac disease: class III or IV congestive heart failure (CHF), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening
- Hepatic insufficiency (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 2 times the central laboratory's upper reference limit)
- Renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females
- Recurrent hypoglycaemia or hypoglycaemic unawareness
- Anemia (haemoglobin below 10 mg/dl)
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT01215435
Start Date
March 1 2011
End Date
September 1 2012
Last Update
October 30 2014
Active Locations (1)
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1
Tehran, Iran