Phase 3
Completed N=276
Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens
Source: ClinicalTrials.gov NCT01365507 ↗Enrolled (actual)
276
Serious AEs
2.6%
Results posted
Nov 2015
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) — -1.33; -1.09 percentage of glycosylated haemoglobin
Summary
This trial is conducted in Asia and North America. The aim of this trial is to compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve subjects with type 2 diabetes mellitus when using two different titration algorithms (dose individually adjusted) as add-on to subject's ongoing treatment with metformin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) |
-1.33; -1.09 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
-2.99; -2.73 | — |
| SECONDARY Rate of Treatment Emergent Adverse Events (AEs) |
226; 342; 2; 13; 3; 3 | — |
| SECONDARY Rate of Confirmed Hypoglycaemic Episodes |
326; 207 | — |
| SECONDARY Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
52; 41 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation (visit 2)
- Insulin naïve subjects (Allowed are: Previous short term insulin treatment no longer than or equal to 14 days in total; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days in total)
- Current treatment: Metformin alone or metformin in any combination of 1 or 2 additional OADs (oral anti-diabetic drug) including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors or thiazolidinediones (TZDs) - all with unchanged dosing for at least 12 weeks prior to randomisation (visit 2). Metformin dose, alone or in combination (including fixed combination), must be at least 1000 mg daily
- HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive)
- BMI (Body Mass Index) below or equal to 45 kg/m^2
- Ability and willingness to adhere to the protocol including self measurement of plasma glucose
Exclusion Criteria
- Treatment with GLP-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
- Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
- Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
- Known or suspected hypersensitivity to trial products or related products
- The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)
- Anticipated significant lifestyle changes during the study, e.g. shift work (including permanent night/evening shift workers) as well as highly variable eating habits
Data sourced from ClinicalTrials.gov (NCT01365507). 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.