Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients
NCT ID: NCT01589653
Last Updated: 2017-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
155 participants
INTERVENTIONAL
2012-05-26
2015-07-09
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
biphasic insulin aspart 30
Dose individually adjusted by the subjects themselves according to the titration algorithm every second week. Administered subcutaneously (s.c., under the skin) twice daily.
Investigator-driven titration
biphasic insulin aspart 30
Dose individually adjusted according to the directions given by the investigator. Administered subcutaneously (s.c., under the skin) twice daily.
Interventions
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biphasic insulin aspart 30
Dose individually adjusted by the subjects themselves according to the titration algorithm every second week. Administered subcutaneously (s.c., under the skin) twice daily.
biphasic insulin aspart 30
Dose individually adjusted according to the directions given by the investigator. Administered subcutaneously (s.c., under the skin) twice daily.
Eligibility Criteria
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Inclusion Criteria
* Currently treated with a NPH insulin for at least 3 months prior to 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 screening
* HbA1c between 7.0% and 10.0% (both inclusive). (One re-test within one week of screening visit is allowed. The last sample will 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 is allowed. The last sample will be conclusive.)
* Impaired kidney function with serum creatinine above or equal to 133 µmol/L (1.5 mg/dL) for males and above or equal to 124 µmol/L (1.4 mg/dL) for females. (One re-test within one week of screening visit is allowed. The last sample will be conclusive.)
* Cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
* Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations)
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Known proliferative retinopathy or maculopathy requiring treatment
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
Alexandria, , Egypt
Novo Nordisk Investigational Site
Banī Suwayf, , Egypt
Novo Nordisk Investigational Site
Cairo, , Egypt
Novo Nordisk Investigational Site
Bandung, , Indonesia
Novo Nordisk Investigational Site
Malang, , Indonesia
Novo Nordisk Investigational Site
Casablanca, , Morocco
Novo Nordisk Investigational Site
Marrakesh, , Morocco
Novo Nordisk Investigational Site
Jeddah, , Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, , Saudi Arabia
Novo Nordisk Investigational Site
Riyadh, , Saudi Arabia
Novo Nordisk Investigational Site
Ta'if, , Saudi Arabia
Novo Nordisk Investigational Site
Tunis, , Tunisia
Novo Nordisk Investigational Site
Tunis, , Tunisia
Novo Nordisk Investigational Site
Hà Nội, , Vietnam
Novo Nordisk Investigational Site
Ho Chi Minh City, , Vietnam
Countries
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References
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Chraibi A, Al-Herz S, Nguyen BD, Soeatmadji DW, Shinde A, Lakshmivenkataraman B, Assaad-Khalil SH. An RCT Investigating Patient-Driven Versus Physician-Driven Titration of BIAsp 30 in Patients with Type 2 Diabetes Uncontrolled Using NPH Insulin. Diabetes Ther. 2017 Aug;8(4):767-780. doi: 10.1007/s13300-017-0268-1. Epub 2017 May 18.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1125-7572
Identifier Type: OTHER
Identifier Source: secondary_id
BIASP-3968
Identifier Type: -
Identifier Source: org_study_id
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