Phase 3
Completed N=272
Comparison of the Efficacy and Safety of Two Different Dose Adjustment Regimens for Insulin Degludec/Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Previously Treated With Insulin Glargine
Source: ClinicalTrials.gov NCT01680341 ↗Enrolled (actual)
272
Serious AEs
6.3%
Results posted
Nov 2015
Primary outcomePrimary: Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) — -1.45; -1.33 Percent (%) glycosylated haemoglobin
Summary
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).
The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) |
-1.45; -1.33 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
-1.68; -1.98 | — |
| SECONDARY Subjects With HbA1c Below 7.0% |
91; 85 | — |
| SECONDARY Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia |
25.4; 32.0 | — |
| SECONDARY Incidence of Treatment Emergent Adverse Events (TEAEs) |
242; 286 | — |
| SECONDARY Number of Treatment Emergent Confirmed Hypoglycaemic Episodes |
552; 323 | — |
| SECONDARY Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period |
230; 143 | — |
| SECONDARY Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes |
82; 49 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to Visit 2 (randomisation)
- Currently treated with IGlar (Insulin Glargine) and up to 3 oral antidiabetic drugs (OADs) (metformin, DPP-4 inhibitor, sulphonylurea/glinide or alpha-glucosidase inhibitor). All antidiabetic treatments should have been ongoing for at least 12 weeks prior to Visit 2 (randomisation) and doses should have been stable in this period of time
- Glycosylated haemoglobin (HbA1c) 7.0-10.0% (both inclusive) by central laboratory analysis
- Body mass index (BMI) below or equal to 40 kg/m^2
Exclusion Criteria
- Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists or thiazolidinediones (TZDs) both within the last 12 weeks prior to Visit 2 (randomisation)
- Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 24 weeks prior to Visit 2 (randomisation)
- Uncontrolled or untreated severe hypertension defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the investigator
- Life-threatening disease (e.g. cancer)
Data sourced from ClinicalTrials.gov (NCT01680341). 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.