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 February 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: February 28, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in HbA1c from baseline [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 180
Study Start Date: May 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589653

Contacts
Contact: Novo Nordisk clinicaltrials@novonordisk.com

Locations
Indonesia
Not yet recruiting
Malang, Indonesia, 65111
Morocco
Not yet recruiting
Rabat, Morocco, 10000
Saudi Arabia
Recruiting
Jeddah, Saudi Arabia, 80215
Tunisia
Recruiting
Tunis, Tunisia, 1008
Vietnam
Not yet recruiting
Ho Chi Minh City, Vietnam
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01589653     History of Changes
Other Study ID Numbers: BIASP-3968, U1111-1125-7572
Study First Received: April 30, 2012
Last Updated: February 28, 2014
Health Authority: Morocco: Ministry of Health
Saudi Arabia: Ministry of Health
Tunisia: Ministry of Public Health
Indonesia: National Agency of Drug and Food Control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Insulin
Metformin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014