Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus When Failing on OADs (IMPROVE)

A Titrate-To-Target Study of the Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs With / Without Once Daily Basal Insulin Therapy

This trial is conducted in Europe.

This is a clinical trial investigating the effectiveness and the safety of using biphasic insulin aspart 30 both for initiation and intensification of insulin treatment in type 2 diabetes.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 343662

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:

• Type 2 Diabetes Mellitus for more than 12 months
• HbA1c: 7.5 - 11.0%
• An antidiabetic regimen that has been stable for at least 3 months prior to screening
• An antidiabetic regimen that includes a minimum of 2 oral anti-diabetic drugs (OADs) or 1 OAD plus evening or bedtime basal insulin
• OADs dosed at 50% or more of the maximum recommended dose

Exclusion Criteria:

• Use of any insulin preparations other than NPH or glargine within the past 6 months
• Use of more than 60 units of insulin per day
• Morning time insulin administration
• Use of more than one insulin dose daily

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIAsp 30; Biphasic insulin aspart 30 administered once daily for 16 weeks. If HbA1c is higher than 7.0 % after 16 weeks of treatment, dose is increased to twice daily for another 16 weeks. If HbA1c is higher than 7.0 % after 32 weeks of treatment, dose is increased to three times daily until week 48 (end of trial).	Drug: biphasic insulin aspart; Treat-to-target dose titration scheme (dose individually adjusted), injected s.c. (under the skin); Other Names: NovoMix 30; NovoLog Mix 70/30; BIasp

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%	week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%		week 48
Number of Hypoglycaemic Episodes	Total number of hypoglycaemic episodes experienced from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.	weeks 0-48
Number of Diurnal Hypoglycaemic Episodes	Total number of hypoglycaemic episodes during the day (diurnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.	weeks 0-48
Number of Nocturnal Hypoglycaemic Episodes	Total number of hypoglycaemic episodes during the night (nocturnal) experienced in the trial from baseline (week 0) to end of trial (week 48). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose (PG) below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no PG or blood glucose measurement or PG higher than or equal to 3.1 mmol/L or 56 mg/dL.	weeks 0-48
Number of Treatment Emergent Serious Adverse Events (SAEs)	Total number of treatment emergent SAEs experienced from baseline (week 0) to end of trial (week 48). A treatment emergent SAE were defined as an adverse event which occurred in the trial treatment period.	weeks 0-48

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: October 1, 2007
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: September 28, 2007
• First Submitted That Met QC Criteria: September 28, 2007
• First Posted (Estimate): October 1, 2007

Study Record Updates

• Last Update Posted (Estimate): December 8, 2014
• Last Update Submitted That Met QC Criteria: November 20, 2014
• Last Verified: November 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 Aspart; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
• Other Study ID Numbers: BIASP-1849