Phase 3
Completed N=373
Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01364428 ↗Enrolled (actual)
373
Serious AEs
5.4%
Results posted
Nov 2015
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) — -0.79; -0.70 percentage of glycosylated haemoglobin
Summary
This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in subjects with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) |
-0.79; -0.70 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
-2.26; -2.40 | — |
| SECONDARY Rate of Treatment Emergent Adverse Events (AEs) |
416; 300; 20; 16; 27; 21 | — |
| SECONDARY Rate of Confirmed Hypoglycaemic Episodes |
517; 566 | — |
| SECONDARY Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
127; 170 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation (visit 2)
- Current treatment with basal-only insulin (no prandial insulin) consisting of either insulin detemir once daily (OD), insulin glargine OD or neutral protamine hagedorn (NPH) insulin OD/twice daily (BID) for at least 12 weeks prior to randomisation (visit 2), in combination with stable doses of OAD(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl peptidase IV (DPP-IV) inhibitor in any approved (according to label) dose or combination. Stable OAD doses are defined as unchanged doses for at least 12 weeks prior to randomisation (visit 2)
- HbA1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central laboratory analysis
- Body mass index (BMI) below or equal to 45 kg/m^2
- Ability and willingness to adhere to the protocol including self-measured plasma glucose (SMPG) according to the protocol
Exclusion Criteria
- Treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit 2)
- Treatment with glucagon like peptide-1 (GLP-1) 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)
Data sourced from ClinicalTrials.gov (NCT01364428). 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.