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
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2012 |
| End Date: | January 2014 |
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.
confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in
controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.
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)
We found this trial at
35
sites
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