BIAsp-3858
- Conditions
- Diabetes Mellitus Type II.Non-insulin-dependent diabetes mellitus type II
- Registration Number
- IRCT201104266297N1
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
2. Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1.
3. Male or female, age =18 years of age
4. HbA1c = 7.0 %- = 11 % at screening
5. Subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)
6. An antidiabetic regimen that has been stable for at least 3 months prior to screening
7. An antidiabetic regimen that includes a minimum of 2 OADs
8. OADs dosed at = 50% of the maximum recommended dose
9. Able and willing to adhere to the therapeutic regimen
10. Able and willing to perform SMBG testing as per protocol
11. Opthalmoscopic examination within 12 months prior to screening
Exclusion Criteria
1. Known or suspected hypersensitivity to trial product(s) or related products
2. 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).
3. The receipt of any investigational medicinal product within one month prior to this trial.
4. Suffer from a life threatening disease (cancer)
5. Active proliferative retinopathy or maculopathy requiring treatment within 6 months prior to Screening
6. Cardiac disease: class III or IV CHF, unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening
7. Hepatic insufficiency (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 2 times the central laboratory's upper reference limit)
8. Renal insufficiency (serum creatinine > 1.6 mg/dl for males; 1.4 mg/dl for females
9. Recurrent hypoglycaemia or hypoglycaemic unawareness
10. Anemia (haemoglobin < 10 mg/dl)
11. Use of concomitant medications which may alter glucose metabolism including but not limited to: systemic or inhaled glucocorticoids, anabolic steroids, non-selective beta-blockers
12. Known or suspected abuse of alcohol, narcotics or illicit substances
13. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write
14. Any conditions that the Investigator judges would interfere with trial participation or evaluation of the results
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c levels. Timepoint: visit 8 (end of phase I). Method of measurement: Laboratory Assessment.
- Secondary Outcome Measures
Name Time Method Percentage of subjects achieving HbA1c < 7%. Timepoint: visit 8, 15 and 23. Method of measurement: Laboratory Assessment.;FPG levels. Timepoint: end of phaseI, II and III, measured at visits 8, 15, 23. Method of measurement: Laboratory Assessment.;8-point plasma glucose profiles. Timepoint: levels at visits 9, 16, 23. Method of measurement: Subcutaneous Measurement of Blood Glucose.;HbA1c level. Timepoint: visits 15 and 23. Method of measurement: Laboratory Assessment.