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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589653
• Other study ID #: BIASP-3968
• Secondary ID: U1111-1125-7572
• Status: Completed
• Phase: Phase 4
• First received: April 30, 2012
• Last updated: July 15, 2015
• Start date: May 2012
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: National Agency of Drug and Food ControlMorocco: Ministry of HealthSaudi Arabia: Ministry of HealthTunisia: Ministry of Public HealthVietnam: Ministry of HealthEgypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• biphasic insulin aspart 30
Dose individually adjusted according to the directions given by the investigator. Administered subcutaneously (s.c., under the skin) twice daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Egypt,  Indonesia,  Morocco,  Saudi Arabia,  Tunisia,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline		Week 0, week 20	No
Secondary	Change in fasting plasma glucose (FPG) (laboratory values) from baseline		Week 0, week 20	No
Secondary	Number of hypoglycaemic episodes during the trial from baseline		Week 20	No
Secondary	Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)		Week 0, week 20	No

External Links

•   Clinical Trials at Novo Nordisk