Clinical trial NCT01589653: Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-05-02
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in HbA1c From Baseline
timeFrame: Week 0, week 20
Secondary outcomes:
measure: Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline
timeFrame: Week 0, week 20
measure: Number of Hypoglycaemic Episodes During the Trial From Baseline
timeFrame: Week 20
measure: Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)
timeFrame: Week 0, week 20
measure: Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden
timeFrame: Week 0, week 20
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Novo Nordisk Investigational Site
city: Beni-Suef
country: Egypt
facility: Novo Nordisk Investigational Site
city: Cairo
country: Egypt
facility: Novo Nordisk Investigational Site
city: Bandung
country: Indonesia
facility: Novo Nordisk Investigational Site
city: Malang
country: Indonesia
facility: Novo Nordisk Investigational Site
city: Casablanca
country: Morocco
facility: Novo Nordisk Investigational Site
city: Marrakech
country: Morocco
facility: Novo Nordisk Investigational Site
city: Jeddah
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Taif
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Tunis
country: Tunisia
facility: Novo Nordisk Investigational Site
city: Tunis
country: Tunisia
facility: Novo Nordisk Investigational Site
city: Ha Noi City
country: Vietnam
facility: Novo Nordisk Investigational Site
city: Ho Chi Minh City
country: Vietnam
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.