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

NCT ID: NCT01215435

Last Updated: 2014-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-09-30

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

Conditions

Diabetes; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pre-breakfast BIAsp 30

Group Type: EXPERIMENTAL

biphasic insulin aspart 30

Intervention Type: DRUG

Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms

Pre-dinner BIAsp 30

Group Type: EXPERIMENTAL

biphasic insulin aspart 30

Intervention Type: DRUG

Administered subcutaneously (under the skin) once daily, before dinner. The trial has 3 treatment phases for both treatment arms

Interventions

biphasic insulin aspart 30

Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms

Intervention Type: DRUG

biphasic insulin aspart 30

Administered subcutaneously (under the skin) once daily, before dinner. The trial has 3 treatment phases for both treatment arms

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Tehran, , Iran

Countries

Iran

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

U1111-1116-2121

Identifier Type: OTHER

Identifier Source: secondary_id

BIASP-3858

Identifier Type: -

Identifier Source: org_study_id