Phase 3
Completed N=222
Comparing the Efficacy and Safety of NN1250 Once Daily When Titrated Using 2 Different Algorithms in Insulin naïve Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01326026 ↗Enrolled (actual)
222
Serious AEs
5.4%
Results posted
Nov 2015
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) — -1.09; -0.93 percentage of glycosylated haemoglobin
Summary
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different self-titration algorithms (dose individually adjusted) in combination with metformin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) |
-1.09; -0.93 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
-3.27; -2.68 | — |
| SECONDARY Rate of Treatment Emergent Adverse Events (AEs) |
346; 379; 15; 15; 15; 10 | — |
| SECONDARY Rate of Confirmed Hypoglycaemic Episodes |
160; 117 | — |
| SECONDARY Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
21; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes (diagnosed clinically) for at least 24 weeks prior to randomisation (Visit 2)
- Current treatment: metformin monotherapy or metformin in any combination with 1 or 2 other OADs including an insulin secretagogue (sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase inhibitors, thiazolidinediones (TZDs) all with unchanged dosing for at least 12 weeks prior to randomisation (Visit 2)-metformin: alone or in combination (including fixed combination) must be at least 1000 mg daily
- HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
- BMI (Body Mass Index) no higher than 45.0 kg/m^2
Exclusion Criteria
- Treatment with glucagon-like peptide 1 (GLP-1) receptor agonist within the last 12 weeks prior to Visit 2
- Suffer from a life threatening disease (e.g. cancer)
- Females of childbearing potential who are pregnant (as determined by central laboratory beta-human chorionic gonadotropin (beta-hCG), breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods as required by law or practise [for Germany, adequate contraceptive methods are: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner])
Data sourced from ClinicalTrials.gov (NCT01326026). 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.