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

An Open Labelled, Randomised, Parallel Trial; Efficacy and Safety Comparison of Two Different Biphasic Insulin Aspart 30 Treatment Initiation Regimens Followed by Intensification in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs Alone in Iran

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 30

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Teheran, Iran, Islamic Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-breakfast BIAsp 30	Drug: biphasic insulin aspart 30; Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms; Drug: biphasic insulin aspart 30; Administered subcutaneously (under the skin) once daily, before dinner. The trial has 3 treatment phases for both treatment arms
Experimental: Pre-dinner BIAsp 30	Drug: biphasic insulin aspart 30; Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms; Drug: biphasic insulin aspart 30; Administered subcutaneously (under the skin) once daily, before dinner. The trial has 3 treatment phases for both treatment arms

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FPG (Fasting Plasma Glucose) From Baseline to Week 36	Estimated mean change from baseline in FPG after 36 weeks of treatment	Week 0, Week 36
Number of Treatment Emergent Hypoglycaemic Episodes	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.	Week 0 to Week 36

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: October 1, 2010
• First Submitted That Met QC Criteria: October 5, 2010
• First Posted (Estimate): October 6, 2010

Study Record Updates

• Last Update Posted (Estimate): October 30, 2014
• Last Update Submitted That Met QC Criteria: October 22, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin, Isophane
• Other Study ID Numbers: BIASP-3858; U1111-1116-2121 (Other Identifier: WHO)