Phase 3
Completed N=145
A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin
Source: ClinicalTrials.gov NCT01570751 ↗Enrolled (actual)
145
Serious AEs
2.8%
Results posted
Nov 2015
Primary outcomePrimary: Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period — -0.1; -0.1 percentage of glycosylated haemoglobin
Summary
This trial is conducted in the United States of America (USA). The aim of the trial is to confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period |
-0.1; -0.1 | — |
| SECONDARY Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period |
-0.8; -0.6; 0.7; 0.4; 11.0; 3.5 | — |
| SECONDARY Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B |
0.02; 0.60; 0.61; 0.21; 10.24; -6.25 | — |
| SECONDARY Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period |
-0.8; -0.0 | — |
| SECONDARY Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B |
-0.78; 0.19 | — |
| SECONDARY Number of Adverse Events (AEs) |
105; 111 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- Current treatment with once daily insulin glargine in vials with a daily dose equal to or above 65 U and equal to or below 100 U
- Current treatment with a stable dose of metformin plus/minus one additional oral antidiabetic drug (OAD) for at least 12 weeks
- Glycosylated haemoglobin (HbA1c) equal to or above 7.5%
Exclusion Criteria
- Current treatment with insulin other than insulin glargine in vials
- Treatment with thiazolidinediones or glucagon-like peptide-1 (GLP-1) receptor agonists within 12 weeks
- Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty
- Suffer from cancer (except basal cell skin cancer and squamous-cell cancer)
Data sourced from ClinicalTrials.gov (NCT01570751). 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.