Phase 4
Completed N=344
Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01618214 ↗Enrolled (actual)
344
Serious AEs
3.2%
Results posted
May 2014
Primary outcomePrimary: Change From Baseline in HbA1c (Glycosylated Haemoglobin) — -1.32; -1.31 percentage of glycosylated haemoglobin
Summary
This trial is conducted in Asia. The aim of this trial is to compare BIAsp 30 twice daily individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by the investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes inadequately controlled with premixed human insulin. Subjects to continue their OAD background treatment: Metformin plus/minus alpha-glucosidase inhibitor.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (Glycosylated Haemoglobin) |
-1.32; -1.31 | — |
| SECONDARY Percentage of Subjects Achieving HbA1c Below 7.0% |
64.5; 58.1 | — |
| SECONDARY Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% |
35.5; 37.2 | — |
| SECONDARY Change From Baseline in FPG (Fasting Plasma Glucose) |
-1.26; -1.48 | — |
| SECONDARY Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only) |
10.04; 10.90; 0.02; 0.02; 1.70; 1.66 | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
- Currently treated with premixed/self-mixed human insulin (proportion of short-acting insulin is equal to or lower than 30%) BID (twice daily) combined with metformin with or without alpha-glucosidase inhibitor for at least 3 months prior to screening visit (Visit 1) with the minimum dose stated: Metformin: at least 1500 mg/day or maximum tolerated dose at least 1000 mg/day (with unchanged dosing within 3 months prior to Visit 1) OR alpha-glucosidase inhibitors: acarbose or miglitol at least 150 mg/day, or voglibose at least 0.6 mg/day
- Total daily insulin dose below 1.4 IU/Kg
- HbA1c above or equal to 7.0% and below or equal to 9.5% (central laboratory)
- Body Mass Index (BMI) below or equal to 35.0 kg/m^2
Exclusion Criteria
- Treatment with any insulin secretagogue, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists within the last 3 months prior to Visit 1
- Previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (CSII)) for more than 14 days
- Previous use of any insulin other than premixed/self-mixed human insulin (proportion of short acting insulin equal to or lower than 30%) BID within 3 month prior to Visit 1
- 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 (NCT01618214). 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.