Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 30 (Drug); biphasic insulin aspart 30 (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s): Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in HbA1c from baseline
Secondary outcome: Change in fasting plasma glucose (FPG) (laboratory values) from baselineNumber of hypoglycaemic episodes during the trial from baseline Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Beni-Suef 62511, Egypt
Malang 65111, Indonesia
Rabat 10000, Morocco
Jeddah 80215, Saudi Arabia
Tunis 1008, Tunisia
Ho Chi Minh City, Vietnam
Additional Information
Clinical Trials at Novo Nordisk
Starting date: May 2012
Last updated: July 15, 2015
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