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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01512108
First received: January 10, 2012
Last updated: April 25, 2014
Last verified: April 2014

January 10, 2012
April 25, 2014
January 2012
April 2013   (final data collection date for primary outcome measure)
Incidence of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 52 + 7 days ] [ Designated as safety issue: No ]
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.
Incidence of adverse events [ Time Frame: After 52 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01512108 on ClinicalTrials.gov Archive Site
  • Number of Confirmed Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 52 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Estimated mean change from baseline in FPG after 52 Weeks of treatment
  • Incidence of hypoglycaemic episodes [ Time Frame: After 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in glycosylated haemoglobin A1c (HbA1c) [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Week 0, week 52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Alone
A 52-week, Multi-centre, Open-labelled, Randomised (2:1), Parallel-group Trial With an Active Control (Two OADs Combination Therapy) to Evaluate the Safety and Efficacy of Liraglutide in Combination With an OAD in Subjects With Type 2 Diabetes Insufficiently Controlled on OAD Monotherapy

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: liraglutide
    0.9 mg/day liraglutide was injected once daily subcutaneously (s.c., under the skin).
  • Drug: oral anti-diabetic drug
    An additional oral anti-diabetic drug (OAD) with a different mechanism of action than the pre-trial OAD. The type and dosage of the additional OAD should be chosen by the investigator within the Japanese labelled dose.
  • Experimental: Liraglutide + an OAD therapy
    Intervention: Drug: liraglutide
  • Active Comparator: Two OADs combination therapy
    Intervention: Drug: oral anti-diabetic drug
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
363
April 2013
April 2013   (final data collection date for primary outcome measure)

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)
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01512108
NN2211-3924, U1111-1121-3457, JapicCTI-121744
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP