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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00537277
First received: September 28, 2007
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0% [ Time Frame: week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0% [ Time Frame: week 48 ] [ Designated as safety issue: No ]
  • Number of Hypoglycaemic Episodes [ Time Frame: weeks 0-48 ] [ Designated as safety issue: No ]
    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.

  • Number of Diurnal Hypoglycaemic Episodes [ Time Frame: weeks 0-48 ] [ Designated as safety issue: No ]
    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.

  • Number of Nocturnal Hypoglycaemic Episodes [ Time Frame: weeks 0-48 ] [ Designated as safety issue: No ]
    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.

  • Number of Treatment Emergent Serious Adverse Events (SAEs) [ Time Frame: weeks 0-48 ] [ Designated as safety issue: No ]
    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.


Enrollment: 161
Study Start Date: October 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • BIasp
  • NovoLog Mix 70/30
  • NovoMix 30

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537277

Locations
Turkey
Istanbul, Turkey, 343662
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Asude Arslan, BSc Novo Nordisk Turkey
Study Director: Suzan Dumanli, MD Novo Nordisk Turkey
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00537277     History of Changes
Other Study ID Numbers: BIASP-1849
Study First Received: September 28, 2007
Results First Received: July 19, 2010
Last Updated: June 15, 2012
Health Authority: Turkey: Ministry of Health Drug and Pharmaceutical Department

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014