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Trial record 63 of 547 for:    INSULIN ASPART

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

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ClinicalTrials.gov Identifier: NCT00537277
Recruitment Status : Completed
First Posted : October 1, 2007
Results First Posted : August 17, 2010
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 2
Intervention Drug: biphasic insulin aspart
Enrollment 161
Recruitment Details One single site in Turkey
Pre-assignment Details Eligible subjects were those with type 2 diabetes inadequately controlled with oral anti-diabetic drugs (OADs) with or without basal insulin therapy.
Arm/Group Title BIAsp 30
Hide Arm/Group Description Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
Period Title: Overall Study
Started 161
Exposed to Trial Drug 160 [1]
Completed 112
Not Completed 49
Reason Not Completed
Adverse Event             1
Lack of Efficacy             2
Lost to Follow-up             12
Protocol Violation             11
Unclassified             4
Inability to tolerate trial medication             4
Non-compliance with trial procedures             15
[1]
One subject not exposed to trial drug, and thus not included in full analysis set (FAS)
Arm/Group Title BIAsp 30
Hide Arm/Group Description Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
Overall Number of Baseline Participants 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 160 participants
54.4  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants
Female
98
  61.3%
Male
62
  38.8%
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 160 participants
31.1  (5.7)
[1]
Measure Description: Body mass index
Diabetes Duration   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 160 participants
9.5  (5.1)
[1]
Measure Description: Number of years since diagnosis
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 160 participants
161  (9.00)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 160 participants
80.2  (15.1)
1.Primary Outcome
Title Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%
Hide Description [Not Specified]
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) was all subjects who have been exposed to at least one dose of trial drug.
Arm/Group Title BIAsp 30
Hide Arm/Group Description:
Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: percentage of subjects
Achieving treatment target HbA1c < 7.0% 34.4
Not achieving treatment target HbA1c < 7.0% 46.9
2.Secondary Outcome
Title Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%
Hide Description [Not Specified]
Time Frame week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) was all subjects who have been exposed to at least one dose of trial drug.
Arm/Group Title BIAsp 30
Hide Arm/Group Description:
Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: percentage of trial completers
Achieving treatment target HbA1c < 7.0% 48.2
Not achieving treatment target HbA1c < 7.0% 51.8
3.Secondary Outcome
Title Number of Hypoglycaemic Episodes
Hide Description 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.
Time Frame weeks 0-48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.
Arm/Group Title BIAsp 30
Hide Arm/Group Description:
Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: episodes
Major 4
Minor 43
Symptom only 15
4.Secondary Outcome
Title Number of Diurnal Hypoglycaemic Episodes
Hide Description 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.
Time Frame weeks 0-48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.
Arm/Group Title BIAsp 30
Hide Arm/Group Description:
Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: episodes
Major 2
Minor 33
Symptom only 13
5.Secondary Outcome
Title Number of Nocturnal Hypoglycaemic Episodes
Hide Description 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.
Time Frame weeks 0-48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.
Arm/Group Title BIAsp 30
Hide Arm/Group Description:
Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: episodes
Major 2
Minor 10
Symptom only 2
6.Secondary Outcome
Title Number of Treatment Emergent Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame weeks 0-48
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set was all subjects who have been exposed to at least one dose of trial drug.
Arm/Group Title BIAsp 30
Hide Arm/Group Description:
Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: events
7
Time Frame Adverse events were collected over a time span of 48 weeks.
Adverse Event Reporting Description Safety analysis set were all subjects who have been exposed to at least one dose of trial drug.
 
Arm/Group Title BIAsp 30
Hide Arm/Group Description Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
All-Cause Mortality
BIAsp 30
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
BIAsp 30
Affected / at Risk (%) # Events
Total   5/160 (3.13%)    
Cardiac disorders   
Acute coronary syndrome  1  1/160 (0.63%)  1
Angina pectoris  1  1/160 (0.63%)  1
Coronary artery disease  1  1/160 (0.63%)  1
Pericardial effusion  1  1/160 (0.63%)  1
Endocrine disorders   
Toxic nodular goitre  1  1/160 (0.63%)  1
Metabolism and nutrition disorders   
Hyperglycaemia  1  1/160 (0.63%)  1
Respiratory, thoracic and mediastinal disorders   
Asphyxia  1  1/160 (0.63%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BIAsp 30
Affected / at Risk (%) # Events
Total   44/160 (27.50%)    
Investigations   
Blood cholesterol increased  1  11/160 (6.88%)  16
Blood potassium increased  1  8/160 (5.00%)  12
Blood triglycerides increased  1  13/160 (8.13%)  18
Low density lipoprotein increased  1  12/160 (7.50%)  14
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Novo Nordisk acknowledges the Investigator’s right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
EMail: clinicaltrials@novonordisk.com
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00537277     History of Changes
Other Study ID Numbers: BIASP-1849
First Submitted: September 28, 2007
First Posted: October 1, 2007
Results First Submitted: July 19, 2010
Results First Posted: August 17, 2010
Last Update Posted: December 8, 2014