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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: biphasic insulin aspart 30

• Registration Number: NCT01215435
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2010-10-01
• Study First Submitted QC: 2010-10-05
• Study First Posted: 2010-10-06
• Study Start: 2011-03
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Disposition First Submitted: 2012-12-19
• Disposition First Submitted QC: 2012-12-19
• Disposition First Posted: 2012-12-24
• Results First Submitted: 2013-09-23
• Results First Submitted QC: 2013-09-23
• Results First Posted: 2013-11-25
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-22
• Last Update Posted: 2014-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-dinner BIAsp 30	biphasic insulin aspart 30	-
Pre-breakfast BIAsp 30	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 11	Week 0, Week 11	Estimated mean change from baseline in HbA1c after 11 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36	Week 0, Week 36	Estimated mean change from baseline in FPG after 36 weeks of treatment
Number of Treatment Emergent Hypoglycaemic Episodes	Week 0 to Week 36	A hypoglycaemic episode will be defined as treatment emergent if the onset of the episode is on or after the first day of trial product, and no later than the last day on trial product.