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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 30

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21131
    • Novo Nordisk Investigational Site
  • Beni-Suef, Egypt, 62511
    • Novo Nordisk Investigational Site
  • Cairo, Egypt, 11562
    • Novo Nordisk Investigational Site
• Indonesia
  • Bandung, Indonesia, 40161
    • Novo Nordisk Investigational Site
  • Malang, Indonesia, 65111
    • Novo Nordisk Investigational Site
• Morocco
  • Casablanca, Morocco, 20100
    • Novo Nordisk Investigational Site
  • Marrakech, Morocco, 40000
    • Novo Nordisk Investigational Site
• Saudi Arabia
  • 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
    • Novo Nordisk Investigational Site
• Tunisia
  • Tunis, Tunisia, 1007
    • Novo Nordisk Investigational Site
  • Tunis, Tunisia, 1008
    • Novo Nordisk Investigational Site
• Vietnam
  • Ha Noi City, Vietnam
    • Novo Nordisk Investigational Site
  • Ho Chi Minh City, Vietnam
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.; 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: Investigator-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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c From Baseline	Change in HbA1c (%) from baseline to the end of the treatment period.	Week 0, week 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline	Change in FPG (laboratory values) from baseline to the end of the treatment period	Week 0, week 20
Number of Hypoglycaemic Episodes During the Trial From Baseline	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.	Week 20
Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)	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.	Week 0, week 20
Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden	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.	Week 0, week 20

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• 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. Erratum In: Diabetes Ther. 2017 Jun 20;:

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2012
• Primary Completion (Actual): July 9, 2015
• Study Completion (Actual): July 9, 2015

Study Registration Dates

• First Submitted: April 30, 2012
• First Submitted That Met QC Criteria: April 30, 2012
• First Posted (Estimate): May 2, 2012

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; 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
• Other Study ID Numbers: BIASP-3968; U1111-1125-7572 (Other Identifier: WHO)