Phase 4
Completed N=155
Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients
Source: ClinicalTrials.gov NCT01589653 ↗Enrolled (actual)
155
Serious AEs
3.3%
Results posted
Aug 2016
Primary outcomePrimary: Change in HbA1c From Baseline — -1.27; -1.04 percentage change in HbA1c — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline |
-1.27; -1.04 | <0.001 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline |
-20.0; -9.1 | — |
| SECONDARY Number of Hypoglycaemic Episodes During the Trial From Baseline |
167; 222 | — |
| SECONDARY Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D) |
1.9; 3.6; 12.7; 6.9; 7.2; 8.9 | — |
| SECONDARY Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden |
10.4; 8.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01589653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.