Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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 treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic drugs) alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)