Phase 3
Completed N=24
A Trial Comparing the Efficacy of Insulin Degludec With Insulin Glargine on Glycaemic Control Using Continuous Glucose Monitoring in Patients With Type 1 Diabetes
Diabetes · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT01569841 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL) — 1.39; 1.09 hours
Summary
This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy of insulin decludec with insulin glargine on glycaemic control using continuous glucose monitoring in patients with type 1 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL) |
1.39; 1.09 | — |
| SECONDARY Mean Interstitial Glucose (IG) Based on 14 Days of CGM |
9.6; 9.8 | — |
| SECONDARY Fasting Plasma Glucose (FPG) |
8.8; 10.9; 10.4; 10.9 | — |
| SECONDARY Glycosylated Haemoglobin (HbA1c) |
6.6; 7.1; 6.9; 7.3 | — |
| SECONDARY Number of Treatment Emergent Adverse Events (AEs) |
18; 16; 0; 0; 3; 0 | — |
| SECONDARY Number of Treatment Emergent Confirmed Hypoglycaemic Episodes |
283; 239 | — |
Eligibility Criteria
Inclusion Criteria
- Type 1 diabetes
- HbA1c (glycosylated haemoglobin) below or equal to 8.5%
- Current treatment with IGlar (insulin glargine) in a basal-bolus regimen with a total daily dose below 120 U
- BMI (body mass index) below 35 kg/m^2
Exclusion Criteria
- Use within the last 3 months prior to visit 1 (screening) of any antidiabetic glucose lowering drug other than insulin/insulin analogues
- Subjects with regular use of acetaminophen who are not willing to use another analgetic during CGM (Continuous Glucose Monitoring) periods
- Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty within 24 weeks prior to visit 1
- Recurrent severe hypoglycemia (more than one severe hypoglycemic event during the last 12 months) or hypoglycemia unawareness or hospitalization for diabetic ketoacidosis during the previous 6 months
Data sourced from ClinicalTrials.gov (NCT01569841). 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.