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

Diabetes Mellitus, Type 2 Clinical Trial

— IMPROVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537277
• Other study ID #: BIASP-1849
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2007
• Last updated: November 20, 2014
• Start date: October 2007
• Est. completion date: January 2009

Study information

• Verified date: November 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health Drug and Pharmaceutical Department
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart
Treat-to-target dose titration scheme (dose individually adjusted), injected s.c. (under the skin)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%		week 48	No
Secondary	Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%		week 48	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Clinical Trials at Novo Nordisk