Phase 3
Completed N=363
Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone
Source: ClinicalTrials.gov NCT01512108 ↗Enrolled (actual)
363
Serious AEs
5.8%
Results posted
May 2014
Primary outcomePrimary: Incidence of Treatment Emergent Adverse Events (AEs) — 361; 331; 345; 321 Events/100 years of patient exposure
Summary
This trial was conducted in Japan. The aim of this trial was to evaluate the safety and efficacy of once daily administration of liraglutide in combination with an oral anti-diabetic drug (OAD) in Japanese subjects with type 2 diabetes who are insufficiently controlled on OAD monotherapy. All subjects will continue their pre-trial OAD (either glinide, metformin, alpha-glucosidase inhibitor or thiazolidinedione) during the trial at unchanged type and dose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment Emergent Adverse Events (AEs) |
361; 331; 345; 321; 14; 9 | — |
| SECONDARY Number of Confirmed Hypoglycaemic Episodes |
7; 2 | — |
| SECONDARY Change in HbA1c From Baseline to Week 52 |
-1.21; -0.94 | 0.0026 sig |
| SECONDARY Change in FPG From Baseline to Week 52 |
-1.55; -1.24 | 0.0458 sig |
Eligibility Criteria
Inclusion Criteria
- Informed consent obtained before any trial-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject.)
- Japanese subjects with type 2 diabetes on monotherapy with an OAD (either glinide, metformin, a-glucosidase inhibitor or thiazolidinedione) within approved Japanese labelling in addition to diet and exercise therapy. Total daily dose and type of drug should have remained unchanged for at least 8 weeks prior to Visit 1
- Type 2 diabetes mellitus (clinically diagnosed) for at least 6 months
- HbA1c between 7.0-10.0% (both inclusive)
- Body Mass Index (BMI) below 40.0 kg/m^2
- Outpatients who have no plans for an educational hospitalisation for the purpose of glycaemic control. However, hospitalisation for training of self-injection from Visit 2 that is for no longer than one week is allowed
- Subjects able and willing to perform self-monitoring of plasma glucose (SMPG)
Exclusion Criteria
- Subjects with known or previous malignant tumor and are strongly suspected of recurrence (except basal cell skin cancer or squamous cell skin cancer)
- Calcitonin above or equal to 160 pg/mL
- Personal history of non-familial medullary thyroid carcinoma
- Family or personal history of multiple endocrine neoplasia type 2 (MEN-2) or familial medullary thyroid carcinoma (FMTC)
- History of chronic pancreatitis or idiopathic acute pancreatitis
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
- Treatment with GLP-1 receptor agonist or dipeptidyl peptidase 4 (DPP-4) inhibitor within 12 weeks prior to Visit 1
- Having contraindications to liraglutide and any of the OADs (according to Japanese labelling)
Data sourced from ClinicalTrials.gov (NCT01512108). 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.