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Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients

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ClinicalTrials.gov Identifier: NCT01589653
Recruitment Status : Completed
First Posted : May 2, 2012
Results First Posted : August 9, 2016
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This trial is conducted in Africa and Asia. The aim of the trial is to compare patient-adjusted versus physician-adjusted titration of BIAsp 30 combined with metformin in type 2 diabetes patients uncontrolled on NPH insulin.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart 30 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 20-week Study Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients Uncontrolled on NPH Insulin
Actual Study Start Date : May 26, 2012
Actual Primary Completion Date : July 9, 2015
Actual Study Completion Date : July 9, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Subject-driven titration Drug: 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.
Experimental: Investigator-driven titration Drug: biphasic insulin aspart 30
Dose individually adjusted according to the directions given by the investigator. Administered subcutaneously (s.c., under the skin) twice daily.


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c From Baseline [ Time Frame: Week 0, week 20 ]
    Change in HbA1c (%) from baseline to the end of the treatment period.


Secondary Outcome Measures :
  1. Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline [ Time Frame: Week 0, week 20 ]
    Change in FPG (laboratory values) from baseline to the end of the treatment period

  2. Number of Hypoglycaemic Episodes During the Trial From Baseline [ Time Frame: Week 20 ]
    The number of hypoglycaemic episodes (a blood glucose level of approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level 3.1 mmol/L [56 mg/dL]) during the trial.

  3. Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D) [ Time Frame: Week 0, week 20 ]
    Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included an overall score as well the subscale scores (daily life, diabetes management, compliance and psychological health). The scores were transformed to a 0-100 scale with higher scores indicating a better health state.

  4. Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden [ Time Frame: Week 0, week 20 ]
    Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included a subscale score -treatment burden. The scores were transformed to a 0-100 scale with higher scores indicating a better health state.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with type 2 diabetes for a minimum of 12 months prior to screening
  • 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:

  • Treatment with any thiazolidinedione (TZD) and Glucagon-like peptide-1 (GLP-1) receptor agonists or pramlintide within the last 3 months prior to screening
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589653


Locations
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Egypt
Novo Nordisk Investigational Site
Alexandria, Egypt, 21131
Novo Nordisk Investigational Site
Beni-Suef, Egypt, 62511
Novo Nordisk Investigational Site
Cairo, Egypt, 11562
Indonesia
Novo Nordisk Investigational Site
Bandung, Indonesia, 40161
Novo Nordisk Investigational Site
Malang, Indonesia, 65111
Morocco
Novo Nordisk Investigational Site
Casablanca, Morocco, 20100
Novo Nordisk Investigational Site
Marrakech, Morocco, 40000
Saudi Arabia
Novo Nordisk Investigational Site
Jeddah, Saudi Arabia, 80215
Novo Nordisk Investigational Site
Riyadh, Saudi Arabia, 11211
Novo Nordisk Investigational Site
Riyadh, Saudi Arabia, 11426
Novo Nordisk Investigational Site
Taif, Saudi Arabia, 21944
Tunisia
Novo Nordisk Investigational Site
Tunis, Tunisia, 1007
Novo Nordisk Investigational Site
Tunis, Tunisia, 1008
Vietnam
Novo Nordisk Investigational Site
Ha Noi City, Vietnam
Novo Nordisk Investigational Site
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01589653    
Other Study ID Numbers: BIASP-3968
U1111-1125-7572 ( Other Identifier: WHO )
First Posted: May 2, 2012    Key Record Dates
Results First Posted: August 9, 2016
Last Update Posted: July 11, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
 Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Biphasic Insulins
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs