Phase 4
Completed N=161
Investigating Efficacy and Safety of Biphasic Insulin Aspart 50 Twice Daily Versus Biphasic Human Insulin 50 Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01892020 ↗Enrolled (actual)
161
Serious AEs
0.6%
Results posted
Jul 2015
Primary outcomePrimary: 2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test — 5.30; 6.41 mmol/L — p=< 0.001
Summary
This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of biphasic insulin aspart 50 (BIAsp 50) twice daily versus biphasic human insulin 50 (BHI 50) twice daily, both in combination with metformin, in Chinese subjects with type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test |
5.30; 6.41 | < 0.001 sig |
| SECONDARY -1-hour PPG Increment Following a Standard Meal Test |
4.42; 4.74 | — |
| SECONDARY -IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test |
465.39; 503.64 | — |
| SECONDARY 2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile |
2.52; 2.86; 3.58; 2.93; 1.08; 0.99 | — |
| SECONDARY The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile |
2.39; 2.25 | — |
| SECONDARY Incidence of Hypoglycemic Episodes |
12.10; 14.38; 0; 0.08; 5.97; 8.33 | — |
| SECONDARY Incidence of AEs (Adverse Event) |
322.7; 245.1 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
- Currently treated with premixed human insulin 50 BID for at least 3 months prior to screening visit (Visit 1)
- Currently treated with unchanged total daily dose of at least 1500 mg metformin or maximum tolerated dose at least 1000 mg/day metformin for at least 2 months prior to screening visit
- Glycosylated haemoglobin (HbA1c) 7.0% and 9.0% (both inclusive) (central laboratory)
Exclusion Criteria
- Treatment with any insulin secretagogue, alfa-glucosidase inhibitors, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists within the last 3 months prior to screening
- Previous use of any insulin other than premixed human insulin 50 BID within 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
Data sourced from ClinicalTrials.gov (NCT01892020). 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.