Phase 3
Completed N=458
A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily (OD) Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01880736 ↗Enrolled (actual)
458
Serious AEs
3.1%
Results posted
Mar 2016
Primary outcomePrimary: Change From Baseline in HbA1c (%) Glycosylated Haemoglobin) — -0.54; -0.62; -0.57; -0.59 Percent (%) glycosylated haemoglobin
◆ Published Evidence
Emerging
14citations · ~1 / year
Efficacy and safety of once-daily insulin degludec dosed flexibly at convenient times vs fixed dosing at the same time each day in a Japanese cohort with type 2 diabetes: A randomized, 26-week, treat-to-target trial.
Summary
This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin degludec in inadequately treated subjects with type 2 diabetes.
Linked Publications (2)
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Efficacy and safety of once-daily insulin degludec dosed flexibly at convenient times vs fixed dosing at the same time each day in a Japanese cohort with type 2 diabetes: A randomized, 26-week, treat-to-target trial.
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Insulin degludec in a simple or stepwise titration algorithm in a Japanese population of patients with type 2 diabetes: a randomized, 26-week, treat-to-target trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c (%) Glycosylated Haemoglobin) |
-0.54; -0.62; -0.57; -0.59 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
-28.8; -25.4; -27.0; -27.2 | — |
| SECONDARY Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial |
90; 95; 91; 94 | — |
| SECONDARY Incidence of Treatment Emergent Adverse Events (TEAEs) |
150; 154; 138; 166 | — |
| SECONDARY Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Defined as Severe Hypoglycaemia and/or a Measured Plasma Glucose (PG) Less Than 3.1 mmol/L (Less Than 56 mg/dL)) |
476; 371; 469; 378 | — |
| SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition |
3053; 2736; 3089; 2700; 0; 1 | — |
| SECONDARY Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period |
227; 192; 241; 178 | — |
| SECONDARY Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes |
77; 58; 80; 55 | — |
| SECONDARY Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period |
34; 23; 40; 17 | — |
Eligibility Criteria
Inclusion Criteria
- Current treatment with IGlar (insulin glargine) with or without OADs (oral antidiabetic drug). All antidiabetic treatments should have been on-going for at least 12 weeks prior to randomisation, and doses of OADs should have been stable in this period of time. - Please note that a maximum of 3 OADs are allowed during this trial: metformin, sulphonylurea (SU)/glinides, dipeptidyl peptidase 4 (DPP-IV) inhibitors, alfa-glucosidaseinhibitors or pioglitazone.
- Diagnosis of T2DM (type 2 diabetes mellitus) at the discretion of the investigator for at least 26 weeks prior to visit 1 (Screening visit)
- HbA1c 7.0-9.5% (both inclusive) by central laboratory analysis
- Body mass index (BMI) equal to or below 35 kg/m^2
Exclusion Criteria
- Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
- Stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 26 weeks prior to Visit 1 (Screening visit)
- Impaired renal function, defined as serum-creatinine higher than or equal to 1.4 mg/dL for males and higher than or equal to 1.3 mg/dL for females
- Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
- Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to randomisation
Data sourced from ClinicalTrials.gov (NCT01880736) and the linked publication. 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.