Phase 3
Completed N=1,143
Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes
Diabetes · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT01831765 ↗
Enrolled (actual)
1,143
Serious AEs
8.4%
Results posted
Jan 2018
Primary outcomePrimary: Change From Baseline in HbA1c (Glycosylated Haemoglobin) — 7.62; 7.63; 7.58; 7.31 Percentage of glycosylated haemoglobin
Summary
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared to insulin aspart, both in combination with insulin detemir in adults with type 1 diabetes. This trial consists of two periods: a 26 week treatment period followed by a 26 week additional treatment period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (Glycosylated Haemoglobin) |
7.62; 7.63; 7.58; 7.31; 7.51; 7.42 | — |
| SECONDARY Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test) |
6.06; 6.06; 6.24; 5.88; 6.73; 6.55 | — |
| SECONDARY Change From Baseline in HbA1c (Post Meal Arm) |
7.63; 7.58; 7.51; 7.42 | — |
| SECONDARY Number of Treatment Emergent Confirmed Hypoglycaemic Episodes |
5899; 5443; 5865 | — |
| SECONDARY Change From Baseline in Body Weight |
78.56; 80.49; 80.15; 79.21; 81.17; 80.69 | — |
| SECONDARY Frequency of Adverse Events |
445.8; 441; 411 | — |
| SECONDARY Change in HbA1c |
7.62; 7.58; 7.51; 7.58 | — |
| SECONDARY Change in PPG (Postprandial Glucose) |
14.51; 14.14; 14.26; 14.51; 6.06; 6.24 | — |
Eligibility Criteria
Inclusion Criteria: - Type 1 diabetes (diagnosed clinically) for 12 months or longer at the time of screening (Visit 1) - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index (BMI) below or equal to 35.0 kg/m^2 Exclusion Criteria: - Use of any anti-diabetic drug other than insulin within the last 3 months prior to screening (Visit 1) - Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1) - Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris, coronary arterial bypass graft or angioplasty
Data sourced from ClinicalTrials.gov (NCT01831765). 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.