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Trial record 62 of 545 for:    INSULIN ASPART

Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

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ClinicalTrials.gov Identifier: NCT00669864
Recruitment Status : Completed
First Posted : May 1, 2008
Results First Posted : July 5, 2010
Last Update Posted : April 1, 2016
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
Interventions Drug: biphasic insulin aspart 30
Drug: metformin
Enrollment 293
Recruitment Details 22 sites in China
Pre-assignment Details Eligible subjects, treated with basal insulin, stopped their oral anti-diabetic drug treatment and started a run-in period of forced metformin titration. Subjects on current metformin therapy could go through a modified titration. Doses were up-titrated weekly until either the max tolerated dose of at least 1500mg/day or a max dose of 2000mg/day.
Arm/Group Title BIAsp 30-30
Hide Arm/Group Description Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
Period Title: Overall Study
Started 293
Completed 284
Not Completed 9
Reason Not Completed
Lost to Follow-up             2
Protocol Violation             2
Withdrawal by Subject             3
Other             2
Arm/Group Title BIAsp 30-30
Hide Arm/Group Description Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
Overall Number of Baseline Participants 293
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 293 participants
54  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 293 participants
Female
139
  47.4%
Male
154
  52.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 293 participants
American Indian or Alaska Native
0
   0.0%
Asian
293
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Previous treatment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 293 participants
Basal insulin analogue 122
Basal human insulin 169
Animal insulin 2
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 293 participants
24.89  (3.28)
[1]
Measure Description: BMI (Body Mass Index) measured at baseline (week 0)
Duration of diabetes   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 293 participants
8.54  (5.49)
[1]
Measure Description: Number of years since diagnosis
HbA1c   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage (%) of total haemoglobin
Number Analyzed 293 participants
8.16  (0.89)
[1]
Measure Description: HbA1c (Glycosylated Haemoglobin A1c) at baseline (week 0)
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 293 participants
68.1  (12.2)
[1]
Measure Description: Weight measured at baseline (week 0)
1.Primary Outcome
Title Change in HbA1c (Glycosylated Haemoglobin A1c)
Hide Description Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)
Time Frame week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.
Arm/Group Title BIAsp 30-30
Hide Arm/Group Description:
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
Overall Number of Participants Analyzed 293
Mean (Standard Error)
Unit of Measure: percentage (%) of total haemoglobin
-1.303  (0.056)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BIAsp 30-30
Comments The null hypothesis (H0): HbA1c after 16 weeks – HbA1c at baseline ≥ 0% against the alternative hypothesis (H1): HbA1c after 16 weeks – HbA1c at baseline < 0%. If H0 rejected at a significance level of 2.5%, declare a significant mean HbA1c decrease
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments A significant mean HbA1c decrease was to be declared if H0 is rejected at a significance level of 2.5%.
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean
Estimated Value -1.303
Confidence Interval 95%
-1.414 to -1.192
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.056
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in 8-point Plasma Glucose Profile
Hide Description Summary of change in 8-point plasma glucose profile by week and time. The 8 time points measured were: Before each meal (breakfast, lunch and dinner), at 2 hours after each meal (breakfast, lunch and dinner), at bedtime, and at 3 AM, measured over 16 weeks of treatment
Time Frame week 0, week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat analysis set (ITT) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.
Arm/Group Title BIAsp 30-30
Hide Arm/Group Description:
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
Overall Number of Participants Analyzed 293
Mean (Standard Error)
Unit of Measure: mg/dL
Before breakfast, N=282 -1.95  (0.15)
2 hours after breakfast, N=282 -3.69  (0.25)
Before lunch, N=279 -2.60  (0.22)
2 hours after lunch, N=282 -2.67  (0.24)
Before dinner, N=282 -2.38  (0.22)
2 hours after dinner, N=281 -3.63  (0.27)
Bedtime, N=279 -3.10  (0.24)
3 AM, N=279 -2.23  (0.18)
3.Secondary Outcome
Title Percentage of Subjects Achieving HbA1c Less Than 7.0%
Hide Description Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below 7.0% after 16 weeks of treatment
Time Frame week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.
Arm/Group Title BIAsp 30-30
Hide Arm/Group Description:
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
Overall Number of Participants Analyzed 293
Measure Type: Number
Unit of Measure: percentage of participants
60.4
4.Secondary Outcome
Title Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%
Hide Description Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below or equal to 6.5% after 16 weeks of treatment
Time Frame week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat analysis set (ITT) using LOCF (Last Observation Carried Forward) is all subjects who entered the trial treatment period and exposed to at least one dose of trial product.
Arm/Group Title BIAsp 30-30
Hide Arm/Group Description:
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
Overall Number of Participants Analyzed 293
Measure Type: Number
Unit of Measure: percentage of participants
38.9
5.Secondary Outcome
Title Hypoglycaemic Episodes
Hide Description Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment). 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 was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.
Time Frame weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set consists of all subjects who entered the trial treatment period and exposed to at least one dose of trial product.
Arm/Group Title BIAsp 30-30
Hide Arm/Group Description:
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
Overall Number of Participants Analyzed 293
Measure Type: Number
Unit of Measure: episodes
Major 0
Minor 39
Symptoms only 203
6.Secondary Outcome
Title Hypoglycaemic Episodes, Diurnal/Nocturnal
Hide Description Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment) during the day (diurnal) and the night (nocturnal).
Time Frame weeks 0-16
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set consists of all subjects who entered the trial treatment period and exposed to at least one dose of trial product.
Arm/Group Title BIAsp 30-30
Hide Arm/Group Description:
Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
Overall Number of Participants Analyzed 293
Measure Type: Number
Unit of Measure: episodes
Diurnal 188
Nocturnal 34
Start time missing 20
Time Frame The adverse events were collected in a time span of 16 weeks.
Adverse Event Reporting Description Safety analysis set consists of all subjects who entered the trial treatment period and exposed to at least one dose of trial product.
 
Arm/Group Title BIAsp 30-30
Hide Arm/Group Description Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
All-Cause Mortality
BIAsp 30-30
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
BIAsp 30-30
Affected / at Risk (%) # Events
Total   0/293 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BIAsp 30-30
Affected / at Risk (%) # Events
Total   80/293 (27.30%)    
Cardiac disorders   
Coronary Artery Disease  1  1/293 (0.34%)  1
Eye disorders   
Eye pain  1  1/293 (0.34%)  1
Vision blurred  1  1/293 (0.34%)  1
Gastrointestinal disorders   
Abdominal discomfort  1  1/293 (0.34%)  1
Abdominal pain  1  2/293 (0.68%)  2
Abdominal pain upper  1  2/293 (0.68%)  2
Diarrhoea  1  4/293 (1.37%)  4
Enteritis  1  1/293 (0.34%)  1
Gastric dilatation  1  1/293 (0.34%)  1
Haemorrhoids  1  1/293 (0.34%)  1
Nausea  1  1/293 (0.34%)  1
Periodontitis  1  1/293 (0.34%)  1
Toothache  1  6/293 (2.05%)  6
Vomiting  1  4/293 (1.37%)  4
General disorders   
Adverse drug reaction  1  1/293 (0.34%)  1
Feeling abnormal  1  1/293 (0.34%)  1
Oedema  1  1/293 (0.34%)  1
Pain  1  1/293 (0.34%)  2
Hepatobiliary disorders   
Hepatic function abnormal  1  6/293 (2.05%)  6
Immune system disorders   
Hypersensitivity  1  1/293 (0.34%)  1
Infections and infestations   
Influenza  1  1/293 (0.34%)  1
Nasopharyngitis  1  15/293 (5.12%)  21
Otitis externa  1  1/293 (0.34%)  1
Pharyngitis  1  1/293 (0.34%)  1
Pneumonia  1  1/293 (0.34%)  1
Upper respiratory tract infection  1  2/293 (0.68%)  2
Injury, poisoning and procedural complications   
Animal bite  1  2/293 (0.68%)  2
Limb injury  1  1/293 (0.34%)  1
Muscle strain  1  1/293 (0.34%)  1
Soft tissue injury  1  1/293 (0.34%)  1
Investigations   
Alanine aminotransferase increased  1  3/293 (1.02%)  3
Blood lactate dehydrogenase increased  1  1/293 (0.34%)  1
Blood triglycerides abnormal  1  1/293 (0.34%)  1
Blood triglycerides increased  1  2/293 (0.68%)  2
Electrocardiogram ST segment depression  1  1/293 (0.34%)  1
Electrocardiogram ST-T segment abnormal  1  1/293 (0.34%)  1
Electrocardiogram T wave abnormal  1  2/293 (0.68%)  2
Lipids abnormal  1  3/293 (1.02%)  3
Lipids increased  1  1/293 (0.34%)  1
Low density lipoprotein abnormal  1  1/293 (0.34%)  1
Metabolism and nutrition disorders   
Hyperlipidaemia  1  14/293 (4.78%)  14
Hypertriglyceridaemia  1  4/293 (1.37%)  4
Hyperuricaemia  1  1/293 (0.34%)  1
Lipid metabolism disorder  1  1/293 (0.34%)  1
Musculoskeletal and connective tissue disorders   
Back pain  1  1/293 (0.34%)  1
Muscle spasms  1  1/293 (0.34%)  1
Periarthritis  1  1/293 (0.34%)  1
Nervous system disorders   
Convulsion  1  1/293 (0.34%)  1
Dizziness  1  1/293 (0.34%)  1
Vascular headache  1  1/293 (0.34%)  2
Renal and urinary disorders   
Renal failure  1  1/293 (0.34%)  1
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain  1  1/293 (0.34%)  1
Vascular disorders   
Hypertension  1  2/293 (0.68%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
This single-armed trial does not permit a comprehensive comparison between BIAsp30 and basal insulin. Otherwise, this could have proffered greater clarity on the putative benefits that BIAsp30 brings to subjects with type 2 diabetes.
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 maintains the right to be informed of any investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
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: NCT00669864     History of Changes
Other Study ID Numbers: BIASP-1960
First Submitted: April 29, 2008
First Posted: May 1, 2008
Results First Submitted: April 29, 2010
Results First Posted: July 5, 2010
Last Update Posted: April 1, 2016