Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus When Failing on OADs (IMPROVE)
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00537277
First received: September 28, 2007
Last updated: June 15, 2012
Last verified: June 2012
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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:
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:
|
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| 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 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin aspart |
Insulin Insulin, NPH Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013