Comparison of Biphasic Insulin Aspart 30 Individually Adjusted by the Subject and the Trial Physician, Both Combined With Metformin in Subjects With Type 2 Diabetes
NCT ID: NCT01427920
Last Updated: 2017-02-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
348 participants
INTERVENTIONAL
2011-09-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Subject-driven titration BIAsp 30 (BID) + metformin
The subjects performed the titration of BIAsp 30 dose.
biphasic insulin aspart 30
Administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued.
Investigator-driven titration BIAsp 30 (BID) + metformin
The investigator performed the titration of BIAsp 30 dose.
biphasic insulin aspart 30
Administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued.
Interventions
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biphasic insulin aspart 30
Administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued.
Eligibility Criteria
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Inclusion Criteria
* Currently treated with a basal insulin analogue for at least 3 months prior to Visit 1 (screening)
* Stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) ± additional OAD treatment. The metformin treatment must have been stable for at least 2 months prior to Visit 1 (screening)
* HbA1c higher or equal to 7.0% and below or equal to 10.0% (one re-test within one week of screening visit was allowed. The last sample was to be conclusive)
* Body Mass Index (BMI) below or equal to 40.0 kg/m\^2
* Able and willing to eat at least 2 main meals each day during the trial
* Able and willing to adhere to the protocol including compliance with performance of self measured plasma glucose (SMPG), injection regimen and titrating themselves according to the protocol
* Experience in performing self measured plasma glucose (SMPG)
Exclusion Criteria
* Impaired hepatic function defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper referenced limit (one re-test within one week of screening visit was allowed. The last sample was to be conclusive)
* Impaired kidney function with serum creatinine above or equal to 133 micromol/L (1.5 mg/dL) for males and above or equal to 124 micromol/L (1.4 mg/dL) for females (one re-test within one week of screening visit was allowed. The last sample was to be conclusive)
* Cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic blood pressure higher or equal to 180 mmHg and/or diastolic blood pressure higher or equal to 100 mmHg)
* Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations) or bolus insulin. Previous use of pre-mixed or bolus insulin products was allowed only in case of hospitalisation or a severe condition requiring intermittent use of pre-mixed or bolus insulin products for less than 14 consecutive days, but not during the last 3 months prior to screening visit (Visit 1)
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Capital Federal, , Argentina
Novo Nordisk Investigational Site
Capital Federal, , Argentina
Novo Nordisk Investigational Site
Chacabuco, , Argentina
Novo Nordisk Investigational Site
Córdoba, , Argentina
Novo Nordisk Investigational Site
Córdoba, , Argentina
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China
Novo Nordisk Investigational Site
Chongqing, Chongqing Municipality, China
Novo Nordisk Investigational Site
Lanzhou, Gansu, China
Novo Nordisk Investigational Site
Zhengzhou, Henan, China
Novo Nordisk Investigational Site
Dalian, Liaoning, China
Novo Nordisk Investigational Site
Tianjin, , China
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India
Novo Nordisk Investigational Site
Belagavi, Karnataka, India
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India
Novo Nordisk Investigational Site
New Delhi, New Delhi, India
Novo Nordisk Investigational Site
Chennai, Tamil Nadu, India
Novo Nordisk Investigational Site
Coimbatore, Tamil Nadu, India
Novo Nordisk Investigational Site
Kolkata, West Bengal, India
Novo Nordisk Investigational Site
Thriruvananthapuram, , India
Novo Nordisk Investigational Site
Bialystok, , Poland
Novo Nordisk Investigational Site
Gdansk, , Poland
Novo Nordisk Investigational Site
Lodz, , Poland
Novo Nordisk Investigational Site
Lubin, , Poland
Novo Nordisk Investigational Site
Ruda Śląska, , Poland
Novo Nordisk Investigational Site
Sopot, , Poland
Novo Nordisk Investigational Site
Warsaw, , Poland
Novo Nordisk Investigational Site
Wroclaw, , Poland
Novo Nordisk Investigational Site
Almería, , Spain
Novo Nordisk Investigational Site
Centelles (Barcelona), , Spain
Novo Nordisk Investigational Site
La Roca Del Vallés (Barcelona), , Spain
Novo Nordisk Investigational Site
Málaga, , Spain
Novo Nordisk Investigational Site
Palma de Mallorca, , Spain
Novo Nordisk Investigational Site
Valencia, , Spain
Novo Nordisk Investigational Site
Vic (Barcelona), , Spain
Novo Nordisk Investigational Site
Doncaster, , United Kingdom
Novo Nordisk Investigational Site
Ipswich, , United Kingdom
Novo Nordisk Investigational Site
Manchester, , United Kingdom
Novo Nordisk Investigational Site
Northwood, , United Kingdom
Novo Nordisk Investigational Site
Reading, , United Kingdom
Novo Nordisk Investigational Site
Scunthorpe, , United Kingdom
Novo Nordisk Investigational Site
Wirral, Merseyside, , United Kingdom
Countries
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References
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Gao Y, Luquez C, Lynggaard H, Andersen H, Saboo B. The SimpleMix study with biphasic insulin aspart 30: a randomized controlled trial investigating patient-driven titration versus investigator-driven titration. Curr Med Res Opin. 2014 Dec;30(12):2483-92. doi: 10.1185/03007995.2014.960512. Epub 2014 Sep 29.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2010-024303-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1118-4096
Identifier Type: OTHER
Identifier Source: secondary_id
BIASP-3878
Identifier Type: -
Identifier Source: org_study_id
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