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

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic insulin aspart 30

Study type: Interventional

Funder types: Industry

Identifiers

NCT01215435

U1111-1116-2121 (Other Identifier)

BIASP-3858

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 2 patient groups

Pre-breakfast BIAsp 30

Experimental group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 30

Pre-dinner BIAsp 30

Experimental group

Treatment:

Drug: biphasic insulin aspart 30

Drug: biphasic insulin aspart 30