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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Novo Nordisk A/S
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01589653
First received: April 30, 2012
Last updated: August 15, 2014
Last verified: August 2014

April 30, 2012
August 15, 2014
May 2012
June 2015   (final data collection date for primary outcome measure)
Change in HbA1c from baseline [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01589653 on ClinicalTrials.gov Archive Site
  • Change in fasting plasma glucose (FPG) (laboratory values) from baseline [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
  • Number of hypoglycaemic episodes during the trial from baseline [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D) [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • 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.
  • 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.
  • Experimental: Subject-driven titration
    Intervention: Drug: biphasic insulin aspart 30
  • Experimental: Investigator-driven titration
    Intervention: Drug: biphasic insulin aspart 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Novo Nordisk clinicaltrials@novonordisk.com
Indonesia,   Morocco,   Saudi Arabia,   Tunisia,   Vietnam
 
NCT01589653
BIASP-3968, U1111-1125-7572
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP