NCT01512108

Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone

Completed Phase 3 Results posted Last updated 18 December 2017

What this trial tests

Phase 3 trial testing liraglutide in Diabetes in 363 participants. Completed in 26 April 2013.

Timeline

10 January 2012

Primary endpoint
26 April 2013

26 April 2013

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	363
Start date	10 January 2012
Primary completion	26 April 2013
Estimated completion	26 April 2013
Sites	36 locations across Japan

Drugs / interventions tested

• liraglutide (liraglutide) — full drug profile →
• oral anti-diabetic drug — full drug profile →

Conditions studied

• Diabetes — all drugs for Diabetes →
• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

20 and older, any sex, with Diabetes or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Treatment Emergent Adverse Events (AEs) Primary · Week 0 to Week 52 + 7 days

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.

All AEs

Group	Value	95% CI
Liraglutide 0.9 mg/Day	361
Additional OAD	331

Mild AEs

Group	Value	95% CI
Liraglutide 0.9 mg/Day	345
Additional OAD	321

Moderate AEs

Group	Value	95% CI
Liraglutide 0.9 mg/Day	14
Additional OAD	9

Severe AEs

Group	Value	95% CI
Liraglutide 0.9 mg/Day	2
Additional OAD	2

Serious AEs

Group	Value	95% CI
Liraglutide 0.9 mg/Day	5
Additional OAD	9

Number of Confirmed Hypoglycaemic Episodes Secondary · Week 0 to Week 52

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).

Group	Value	95% CI
Liraglutide 0.9 mg/Day	7
Additional OAD	2

Change in HbA1c From Baseline to Week 52 Secondary · Week 0, week 52

Estimated mean change in HbA1c from baseline after 52 Weeks of treatment

Group	Value	95% CI
Liraglutide 0.9 mg/Day	-1.21	± 0.05
Additional OAD	-0.94	± 0.07

Change in FPG From Baseline to Week 52 Secondary · Week 0, week 52

Estimated mean change from baseline in FPG after 52 Weeks of treatment

Group	Value	95% CI
Liraglutide 0.9 mg/Day	-1.55	± 0.09
Additional OAD	-1.24	± 0.12

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were captured from the time of consent until 52 weeks of treatment and if needed were followed up after the final visit.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Liraglutide 0.9 mg/Day

Serious: 11/240 (5%)

Deaths: —

Additional OAD

Serious: 10/120 (8%)

Deaths: —

Serious adverse events (21 terms)

Reaction	System	Liraglutide 0.9 mg/Day	Additional OAD
Arteriosclerosis coronary artery	Cardiac disorders	—	—
Cardiac failure	Cardiac disorders	—	—
Deafness neurosensory	Ear and labyrinth disorders	—	—
Diabetic retinopathy	Eye disorders	—	—
Enterocolitis	Gastrointestinal disorders	—	—
Inguinal hernia	Gastrointestinal disorders	—	—
Chest pain	General disorders	—	—
Meningitis herpes	Infections and infestations	—	—
Fall	Injury, poisoning and procedural complications	—	—
Foot fracture	Injury, poisoning and procedural complications	—	—
Road traffic accident	Injury, poisoning and procedural complications	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Gastric cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Large intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Lung carcinoma unspecified stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Prostate cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Cerebral infarction	Nervous system disorders	—	—
Benign prostatic hyperplasia	Reproductive system and breast disorders	—	—
Limb operation	Surgical and medical procedures	—	—

Other adverse events (11 terms — click to expand)

Reaction	System	Liraglutide 0.9 mg/Day	Additional OAD
Nasopharyngitis	Infections and infestations	—	—
Constipation	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Diabetic retinopathy	Eye disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Headache	Nervous system disorders	—	—
Cataract	Eye disorders	—	—
Influenza	Infections and infestations	—	—
Dental caries	Gastrointestinal disorders	—	—

Most-reported serious reactions: Arteriosclerosis coronary artery, Cardiac failure, Deafness neurosensory, Diabetic retinopathy, Enterocolitis, Inguinal hernia, Chest pain, Meningitis herpes.

Data from ClinicalTrials.gov NCT01512108 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.