NCT01589653

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

Completed Phase 4 Results posted Last updated 11 July 2017

What this trial tests

Phase 4 trial testing biphasic insulin aspart 30 in Diabetes in 155 participants. Completed in 9 July 2015.

Timeline

26 May 2012

Primary endpoint
9 July 2015

9 July 2015

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	155
Start date	26 May 2012
Primary completion	9 July 2015
Estimated completion	9 July 2015
Sites	15 locations across Tunisia, Saudi Arabia, Indonesia, Vietnam, Morocco, Egypt

Drugs / interventions tested

• biphasic insulin aspart 30 — full drug profile →
• biphasic insulin aspart 30 — full drug profile →

Conditions studied

• Diabetes — all drugs for Diabetes →
• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

18 and older, any sex, with Diabetes or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in HbA1c From Baseline Primary · Week 0, week 20

Change in HbA1c (%) from baseline to the end of the treatment period.

Group	Value	95% CI
Subject-driven Titration	-1.27	± 0.11
Investigator-driven Titration	-1.04	± 0.11

Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline Secondary · Week 0, week 20

Change in FPG (laboratory values) from baseline to the end of the treatment period

Group	Value	95% CI
Subject-driven Titration	-20.0	± 67.23
Investigator-driven Titration	-9.1	± 62.99

Number of Hypoglycaemic Episodes During the Trial From Baseline Secondary · 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.

Group	Value	95% CI
Subject-driven Titration	167
Investigator-driven Titration	222

Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D) Secondary · 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.

Daily life

Group	Value	95% CI
Subject-driven Titration	1.9	± 21.84
Investigator-driven Titration	3.6	± 20.04

Diabetes management

Group	Value	95% CI
Subject-driven Titration	12.7	± 22.79
Investigator-driven Titration	6.9	± 22.77

Compliance

Group	Value	95% CI
Subject-driven Titration	7.2	± 27.69
Investigator-driven Titration	8.9	± 19.54

Psychological health

Group	Value	95% CI
Subject-driven Titration	8.4	± 23.97
Investigator-driven Titration	6.1	± 21.82

Total score

Group	Value	95% CI
Subject-driven Titration	8.2	± 16.52
Investigator-driven Titration	6.6	± 15.14

Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden Secondary · 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.

Group	Value	95% CI
Subject-driven Titration	10.4	± 21.00
Investigator-driven Titration	8.0	± 22.90

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events from the first trial related activity after the subject has signed the informed consent and until post treatment follow-up period.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Subject-driven Titration

Serious: 0/76 (0%)

Deaths: —

Investigator-driven Titration

Serious: 5/78 (6%)

Deaths: —

Serious adverse events (5 terms)

Reaction	System	Subject-driven Titration	Investigator-driven Titrat…
Dyspepsia	Gastrointestinal disorders	—	—
Cholelithiasis	Hepatobiliary disorders	—	—
Localised infection	Infections and infestations	—	—
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Transient ischaemic attack	Nervous system disorders	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Subject-driven Titration	Investigator-driven Titrat…
Headache	Nervous system disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Influenza	Infections and infestations	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—

Most-reported serious reactions: Dyspepsia, Cholelithiasis, Localised infection, Invasive ductal breast carcinoma, Transient ischaemic attack.

Data from ClinicalTrials.gov NCT01589653 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. An RCT Investigating Patient-Driven Versus Physician-Driven Titration of BIAsp 30 in Patients with Type 2 Diabetes Uncontrolled Using NPH Insulin.
   Chraibi A, Al-Herz S, Nguyen BD, Soeatmadji DW, et al · · 2017 · cited 5× · PMID 28523482 · DOI 10.1007/s13300-017-0268-1