Phase 3
Completed N=543
Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT02762578 ↗Enrolled (actual)
543
Serious AEs
5.6%
Results posted
Dec 2018
Primary outcomePrimary: Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin) — -1.48; -1.40 percentage of HbA1c — p=0.2430
◆ Published Evidence
Established
28citations · ~4 / year
Efficacy and safety of insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Chinese adults with type 2 diabetes: A phase III, open-label, 2:1 randomized, treat-to-target trial.
Summary
This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin degludec/insulin aspart and BIAsp 30 in subjects with type 2 diabetes.
Linked Publications (3)
-
Efficacy and safety of insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Chinese adults with type 2 diabetes: A phase III, open-label, 2:1 randomized, treat-to-target trial.
-
Cost-effectiveness of insulin degludec/insulin aspart versus biphasic insulin aspart in Chinese population with type 2 diabetes.
-
Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin) |
-1.48; -1.40 | 0.2430 |
| SECONDARY Change From Baseline in FPG (Fasting Plasma Glucose) |
-2.99; -1.57 | <0.0001 sig |
| SECONDARY Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes |
31.18; 58.55 | 0.0112 sig |
| SECONDARY Number of Treatment Emergent Confirmed Hypoglycaemic Episodes |
223.56; 394.17 | 0.0002 sig |
| SECONDARY Change From Baseline in Body Weight |
2.82; 2.21 | 0.0092 sig |
| SECONDARY Responder Without Confirmed Hypoglycaemic Episodes HbA1c Below 7.0% |
153; 48; 195; 125 | 0.0002 sig |
| SECONDARY Incidence of Treatment Emergent Adverse Events (TEAEs) |
321.74; 348.82 | — |
| SECONDARY Responder for HbA1c (HbA1c <7%) After 26 Weeks of Treatment |
201; 88; 160; 94 | — |
| SECONDARY Responder for HbA1c (HbA1c <=6.5%) After 26 Weeks of Treatment |
106; 54; 255; 128 | — |
| SECONDARY Responder for HbA1c (HbA1c <7%) Without Severe Hypoglycaemic Episodes |
197; 84; 151; 89 | — |
| SECONDARY Responder for HbA1c (HbA1c ≤6.5%) Without Confirmed Hypoglycaemic Episodes |
82; 26; 266; 147 | — |
| SECONDARY Responder for HbA1c (HbA1c ≤6.5%) Without Severe Hypoglycaemic Episodes |
105; 50; 243; 123 | — |
| SECONDARY 9-point Profile (SMPG) After 26 Weeks of Treatment |
5.81; 6.81; 8.68; 9.56; 6.47; 6.65 | — |
| SECONDARY Mean of the 9-point Profile (SMPG) After 26 Weeks of Treatment |
7.70; 8.11 | — |
| SECONDARY Fluctuation in the 9-point Profile (SMPG) After 26 Weeks of Treatment |
1.40; 1.43 | — |
| SECONDARY 9-point Profile (SMPG) - Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment |
2.95; 2.60 | — |
| SECONDARY 2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Time From Randomisation (Measured in Weeks) to Achieve Titration Targets |
NA; NA | — |
| SECONDARY 2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Within-subject Variability as Measured by Coefficient of Variance (CV)% After 26 Weeks of Treatment |
17.26; 17.19; 22.45; 22.96 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition During 26 Weeks of Treatment |
1699.53; 1585.31 | — |
| SECONDARY Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period |
159.08; 361.18 | — |
| SECONDARY Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes in the Maintenance Period |
19.20; 38.60 | — |
| SECONDARY Change in Health Related Quality of Life Questionnaire (SF -36) |
0.19; -0.13; -1.01; -0.50; 0.41; -0.18 | — |
| SECONDARY Change in Treatment Satisfaction Questionnaire (Treatment Related Impact Measure-diabetes [TRIM-D]) |
4.87; 4.11 | — |
| SECONDARY Treatment Satisfaction Questionnaire (Treatment Related Impact Measures - Diabetes Device [TRIM-D Device]) |
72.31; 69.43 | — |
| SECONDARY Device Specific Questionnaires I (How Easy or Difficult is it to Read the Dose Scale) |
220; 104; 128; 69; 10; 5 | — |
| SECONDARY Device Specific Questionnaires I (How Easy or Difficult do You Find it to Hold the Pen Stable When Injecting?) |
228; 99; 121; 72; 8; 7 | — |
| SECONDARY Device Specific Questionnaires I (How Easy or Difficult is it to Hear the Clicks for Each Unit Increment?) |
230; 108; 119; 63; 9; 6 | — |
| SECONDARY Device Specific Questionnaires I (How Easy or Difficult is it to Feel the Clicks for Each Unit Increment?) |
217; 103; 128; 65; 12; 9 | — |
| SECONDARY Device Specific Questionnaires I (How Easy or Difficult is it to Push Down the Injection Button?) |
224; 89; 125; 75; 9; 14 | — |
| SECONDARY Device Specific Questionnaires I (How Easy/Difficult is it to Turn the Dose Selector When Choosing the Right Dose?) |
222; 99; 128; 72; 7; 6 | — |
| SECONDARY Device Specific Questionnaires I (How Easy/Difficult is it to Know if the Push Button Has Been Pushed Completely Down?) |
213; 92; 134; 77; 11; 9 | — |
| SECONDARY Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?) |
1; 0; 215; 94; 126; 78 | — |
| SECONDARY Device Specific Questionnaires I (How Confident Are You That You Set the Insulin Dose Correctly Every Time?) |
209; 85; 43; 26; 106; 65 | — |
| SECONDARY Device Specific Questionnaires I (How Confident Are You That You Inject the Correct Amount of Insulin Every Time?) |
202; 83; 52; 28; 104; 67 | — |
| SECONDARY Device Specific Questionnaires I (Overall, How Confident Are You in Your Management of Your Daily Insulin Injections Using This Pen?) |
197; 82; 59; 39; 102; 57 | — |
| SECONDARY Device Specific Questionnaires I (Overall, How Confident Are You in Controlling Your Blood Sugar Level Using This Pen?) |
180; 71; 85; 60; 92; 42 | — |
| SECONDARY Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?) |
129; 60; 117; 64; 0; 1 | — |
| SECONDARY Device Specific Questionnaires I (How Confident Are You That the Air Shot Has Been Done Correctly?) |
157; 73; 85; 55; 109; 47 | — |
| SECONDARY Device Specific Questionnaires I (How Convenient do You Find the Size of the Pen?) |
143; 63; 109; 69; 101; 42 | — |
| SECONDARY Device Specific Questionnaires I (How Comfortable do You Find the Handling of the Pen?) |
146; 66; 107; 68; 104; 44 | — |
| SECONDARY Device Specific Questionnaires I (Did You Have Any Problems Using the Pen?) |
12; 8; 346; 169 | — |
| SECONDARY Device Specific Questionnaires II (How Easy or Difficult Was it to Learn How to Use This Pen?) |
206; 92; 145; 79; 7; 7 | — |
| SECONDARY Device Specific Questionnaires II (How Easy or Difficult is it to Distinguish Between Dialling up and Down?) |
203; 91; 144; 81; 10; 6 | — |
| SECONDARY Device Specific Questionnaires II (How Easy or Difficult is it to Inject Your Usual Insulin Dose?) |
193; 93; 154; 81; 11; 3 | — |
| SECONDARY Device Specific Questionnaires II (How Easy/Difficult is it to Reach the Dose Button When Inject Your Insulin Dose?) |
193; 90; 153; 82; 11; 6 | — |
| SECONDARY Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?) |
167; 77; 169; 85; 20; 16 | — |
| SECONDARY Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?) |
1; 0; 184; 79; 54; 42 | — |
| SECONDARY Device Specific Questionnaires II (Would You Recommend the Pen?) |
338; 161; 19; 17 | — |
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
- Male or female at least 18 years of age
- Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
- Insulin treated subjects on current treatment: basal insulin, premixed insulin or a self-mixed insulin regimen, all administered once daily (OD) or BID with or without metformin. The treatment regimen should have remained unchanged for at least 8 weeks prior to randomisation
- HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
- Body mass index (BMI) equal or below 40.0 kg/m^2
Exclusion Criteria
- Treatment with sulphonylureas, meglitinides, DPP-4 inhibitors, alpha-glycosidase inhibitors within 8 weeks prior to screening (Visit 1) or thiazolidinediones (TZDs) or GLP-1 receptor agonists within 12 weeks prior to screening (Visit 1)
- Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers and monoamine oxidase (MAO) inhibitors
- Anticipated significant lifestyle changes during the trial according to the discretion of the investigator, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits
- Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as: stroke; decompensated heart failure NYHA1 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
- Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the investigator's opinion could interfere with the results of the trial
- Previous participation in this trial. Participation is defined as screened.
- Known or suspected hypersensitivity to trial products or related products
Data sourced from ClinicalTrials.gov (NCT02762578) 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.