Phase 4
Completed N=437
Comparing Efficacy and Safety of Thrice Daily Versus Twice Daily NovoMix® 30 (Biphasic Insulin Aspart 30) in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin
Source: ClinicalTrials.gov NCT02582242 ↗Enrolled (actual)
437
Serious AEs
4.8%
Results posted
May 2018
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) — -1.66; -1.52 Percentage (%) of HbA1c — p=0.2601
◆ Published Evidence
Emerging
6citations · ~1 / year
Efficacy and safety of three-times-daily versus twice-daily biphasic insulin aspart 30 in patients with type 2 diabetes mellitus inadequately controlled with basal insulin combined with oral antidiabetic drugs.
Summary
This trial is conducted in Asia. The aim of the trial is to compare efficacy and safety of thrice daily versus twice daily NovoMix® 30 (Biphasic insulin aspart 30) in subjects with type 2 diabetes inadequately controlled with basal insulin.
Linked Publications
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Efficacy and safety of three-times-daily versus twice-daily biphasic insulin aspart 30 in patients with type 2 diabetes mellitus inadequately controlled with basal insulin combined with oral antidiabetic drugs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) |
-1.66; -1.52 | 0.2601 |
| SECONDARY Proportion of Subjects Achieving HbA1c Below 7.0% |
54.5; 47.5; 45.5; 52.5 | — |
| SECONDARY Proportion of Subjects Achieving HbA1c Below 7.0% Without Severe Hypoglycaemic Episodes. |
50.0; 44.7; 50.0; 55.3 | — |
| SECONDARY Proportion of Subjects Achieving HbA1c Below 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes (According to the Novo Nordisk Classification) |
27.3; 21.7; 72.7; 78.3 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition |
3; 3; 397; 344; 642; 765 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes Classified According to Novo Nordisk Definition |
3; 3; 249; 249; 252; 252 | — |
| SECONDARY Change From Baseline in FPG by Central Laboratory Analysis |
-1.34; -1.07 | — |
| SECONDARY 7-point SMPG Profile |
6.87; 6.86; 9.33; 9.04; 6.86; 7.09 | — |
| SECONDARY 7-point SMPG Profiles: Change From Baseline in 2-hour PPG at Individual Meal (Breakfast, Lunch and Main Evening Meal) |
-4.17; -4.03; -3.43; -3.27; -4.38; -4.09 | — |
| SECONDARY 7-point SMPG Profiles: Change From Baseline in PPG Increment at Individual Meal (Breakfast, Lunch and Main Evening Meal) |
-2.06; -2.02; -0.13; -0.14; -0.64; -1.60 | — |
| SECONDARY 7-point SMPG Profiles: Change From Baseline in Mean of 2-hour PPG Over 3 Main Meals (Breakfast, Lunch and Main Evening Meal) |
-3.98; -3.77 | — |
| SECONDARY 7-point SMPG Profiles: Change From Baseline in Mean of PPG Increment Over 3 Main Meals (Breakfast, Lunch and Main Evening Meal) |
-0.96; -1.22 | — |
| SECONDARY 7-point SMPG Profiles: Change From Baseline in Mean of the 7-point Profile |
-3.58; -3.27 | — |
| SECONDARY 7-point SMPG Profiles: Fluctuation in the 7-point Profile |
1.04; 1.05 | — |
| SECONDARY Incidence of Treatment Emergent Adverse Events (TEAEs) |
275; 251 | — |
| SECONDARY Total Daily Insulin Dose |
24.5; 24.2; 67.4; 63.4 | — |
| SECONDARY Change From Baseline in Body Weight |
1.45; 1.65 | — |
| SECONDARY Change From Baseline in Patient-reported Treatment Satisfaction as Assessed by the Diabetes Treatment Satisfaction Questionnaire (Status) (DTSQs) |
2; 4; 0; 0; -1; -1 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, age at least 18 years at the time of signing informed consent. For Algeria only: age at least 19 years at the time of signing informed consent
- Type 2 diabetes subjects clinically diagnosed for at least 12 months prior to the day of screening (Visit 1)
- Treated with basal insulin for at least 90 days prior to the day of screening (Visit 1). The following basal insulin are allowed : insulin analogue once daily (OD) Neutral Protamine Hagedorn (NPH) OD or BID (twice daily)
- Treatment with metformin with or without one additional OAD (oral antidiabetic drug) for at least 90 days prior to the day of screening (Visit 1) Metformin must be at a stable dose of at least 1500 mg daily or maximum tolerated dose for at least 60 days prior to screening (Visit 1) One additional OAD:Sulphonylurea/Glinides/ a-glucosidase inhibitors/Dipeptidyl-peptidase-4 inhibitors/Sodium glucose co-transporter 2 (SGLT2) inhibitors (if applicable)
- HbA1c (glycosylated haemoglobin) 7.5%-10.0% (both inclusive) by central laboratory analysis at screening (Visit 1)
- Able and willing to intake three main meals daily (breakfast, lunch and main evening meal) throughout the trial. Definition of main meal as judged by the investigator
Exclusion Criteria
- Previous insulin intensification regimen for more than 14 days: premixed insulin thrice daily, basal-bolus regimen or continuous subcutaneous insulin infusion (CSII). Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days
- Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, systemic corticosteroids)
- Impaired liver function, defined as alanine aminotransferase (ALT) equal to or above 2.5 times upper normal limit at screening (Visit 1)
Data sourced from ClinicalTrials.gov (NCT02582242) and the linked publication. 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.