NCT00624364 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Naiker P, Makan HA, Kedijang T, Kong LLL, Omar MAK & the BIAsp-1579 Study Group
Effects of Once-Daily Biphasic Insulin Aspart 30 with Metformin versus Twice-Daily Biphasic Insulin Aspart 30 in South African Type 2 Diabetes Subjects. Society for Endocrino
Naiker P, Makan HA, Omar MAK, Kedijang T, Kong LLL, the BIAsp-1579 Study Group
Effect of biphasic insulin aspart 30/70 (BIAsp30) in combination with metformin on glycaemic control in subjects with type 2 diabetes not optimally controlled on oral antidiab
Naiker P, Makan HA, Omar MAK, Kedijang T, Kong LLL, the BIAsp-1579 Study Group
Efficacy of biphasic insulin aspart 30/70 with metformin on glycaemic control in poorly-controlled type 2 diabetes. IDF 2006 2006; 23(Suppl 4): 339 (P940)

Comparison of Efficacy and Safety of Biphasic Insulin Aspart Plus Metformin to Biphasic Insulin Aspart Monotherapy in Subjects With Type 2 Diabetes

Clinical trial NCT00624364 - References