Primary outcomeNumber· Week 0 to Week 52 + 7 days
Incidence of Treatment Emergent Adverse Events (AEs)
| Group | Value (Events/100 years of patient exposure) |
|---|---|
| Liraglutide 0.9 mg/Day | 361 |
| Additional OAD | 331 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataSafety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone
NCTNCT01512108 (opens ClinicalTrials.gov in a new tab)Other idNN2211-3924Other idU1111-1121-3457Other idJapicCTI-121744
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 363 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Japan
- Start
- 10 Jan 2012
- Primary completion
- 26 Apr 2013
- Completion
- 26 Apr 2013
- First posted
- 19 Jan 2012 (estimated)
- Last update posted
- 18 Dec 2017
- Conditions
- Diabetes · Diabetes Mellitus, Type 2
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201220132014
- Ph 3
Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone
NCT0151210810 Jan 2012 to 26 Apr 2013
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- liraglutideDrug
- oral anti-diabetic drugDrug
Arms2
Experimental
Liraglutide + an OAD therapy
Active comparator
Two OADs combination therapy
Primary outcomes1
Outcomes the sponsor listed as primary.
Incidence of Treatment Emergent Adverse Events (AEs)
Time frame · Week 0 to Week 52 + 7 days
Registry description
Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly.
Secondary outcomes(3)
Number of Confirmed Hypoglycaemic Episodes
Time frame · Week 0 to Week 52
Registry description
Confirmed hypoglycaemic episodes consisted of the pool of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes \[An episode with symptoms consistent with hypoglycaemia with confirmation by plasma glucose \<3.1 mmol/L (56 mg/dL) or full blood glucose \<2.8 mmol/L (50 mg/dL) and which is handled by the subject himself or herself or any asymptomatic PG value \<3.1 mmol/L (56 mg/dL) or full blood glucose value \<2.8 mmol/L (50 mg/dL)\] with a confirmed plasma glucose value of less than 3.1 mmol/L (56 mg/dL).
Change in HbA1c From Baseline to Week 52
Time frame · Week 0, week 52
Registry description
Estimated mean change in HbA1c from baseline after 52 Weeks of treatment
Change in FPG From Baseline to Week 52
Time frame · Week 0, week 52
Registry description
Estimated mean change from baseline in FPG after 52 Weeks of treatment
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(3)
Secondary outcomeNumber· Week 0 to Week 52
Number of Confirmed Hypoglycaemic Episodes
| Group | Value (episodes) |
|---|---|
| Liraglutide 0.9 mg/Day | 7 |
| Additional OAD | 2 |
Secondary outcomeMean· Week 0, week 52
Change in HbA1c From Baseline to Week 52
| Group | Value (percentage of glycosylated haemoglobin) | Spread |
|---|---|---|
| Liraglutide 0.9 mg/Day | -1.21 | 0.05 |
| Additional OAD | -0.94 | 0.07 |
Secondary outcomeMean· Week 0, week 52
Change in FPG From Baseline to Week 52
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Liraglutide 0.9 mg/Day | -1.55 | 0.09 |
| Additional OAD | -1.24 | 0.12 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Liraglutide 0.9 mg/DayLiraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg. | – | 11 / 240 | 161 / 240 |
| Additional OADSubject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual's glycaemic control by the investigator as per Japanese labelling. | – | 10 / 120 | 77 / 120 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2018
6 results
Safety and efficacy of the combination of the glucagon-like peptide-1 receptor agonist liraglutide with an oral antidiabetic drug in Japanese patients with type 2 diabetes: Post-hoc analysis of a randomized, 52-week, open-label, parallel-group trial.
Kiyosue et al. 2018Journal of diabetes investigationcited by 5
PMID 28984041PMC6031500DOI 10.1111/jdi.12759PUB-28984041
Free to read · publisher termsCC BY-NC6 results
More studies
1 study on this page
Indexing hint: Randomized controlled trial · 2016
Corrected
Liraglutide is effective and well tolerated in combination with an oral antidiabetic drug in Japanese patients with type 2 diabetes: A randomized, 52-week, open-label, parallel-group trial.
Kaku et al. 2016Journal of diabetes investigationcited by 18
PMID 26816604PMC4718097DOI 10.1111/jdi.12367PUB-26816604
Free to read · publisher termsCC BY-NC-ND
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 20 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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)
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