Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes (LIRA-LIXI™)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01973231
First received: October 23, 2013
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

This trial is conducted in Europe. The aim of the trial is to investigate the efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes (T2DM).


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide
Drug: lixisenatide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in glycosylated haemoglobin (HbA1c) from baseline [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in fasting plasma glucose (FPG) from baseline [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Change in body weight from baseline [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Subjects who achieve HbA1c below 7.0% (53 mmol/mol) (American Diabetes Association (ADA) target) (yes/no) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Subjects who achieve HbA1c equal to or below 6.5% (48 mmol/mol) ((American Association of Clinical Endocrinologists (AACE) target) (yes/no) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Subjects who achieve HbA1c below 7.0% (53 mmol/mol) and no weight gain (yes/no) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: Weeks 0-26 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin + liraglutide 1.8 mg Drug: liraglutide
Starting dose of 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day is reached. Administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial metformin (equal to or above 1000 mg/day and up to 3000 mg/day).
Active Comparator: Metformin + lixisenatide 20 microg Drug: lixisenatide
Starting dose of 10 microg to be administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (equal to or above 1000mg/day and up to 3000mg/day). Dose escalation to 20 microg s.c. once daily from day 15 after randomization.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
  • Subjects diagnosed with T2DM and on unchanged metformin treatment at the maximum tolerated dose (at least 1000 mg/day and up to 3000 mg/day) for at least 90 days prior to screening
  • HbA1c 7.5 - 10.5% (53 mmol/mol - 91 mmol/mol) (both inclusive)
  • Body Mass Index (BMI) equal to or above 20 kg/m^2

Exclusion Criteria:

  • Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods. (Adequate contraceptive measures as required by local law or practice)
  • Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. Exception is short-term treatment (equal to or below 7 days in total) with insulin in connection with intercurrent illness
  • History of chronic pancreatitis or idiopathic acute pancreatitis
  • Screening calcitonin value equal to or above 50 ng/L
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
  • Impaired liver function, defined as alanine aminotransferase (ALAT) equal to or above 2.5 times upper normal limit (UNL)
  • Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m^2 per Modification of Diet in Renal Disease (MDRD) formula
  • Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack (TIA) or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
  • Heart failure, New York Heart Association (NYHA) class IV
  • Uncontrolled hypertension (defined as systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg)
  • Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01973231

Locations
Czech Republic
Mlada Boleslav, Czech Republic, 293 50
Finland
Oulu, Finland, FI-90100
France
Strasbourg, France, 67000
Germany
Lampertheim, Germany, 68623
Hungary
Budapest, Hungary, 1042
Italy
Palermo, Italy, 90129
Latvia
Riga, Latvia, LV-1012
Lithuania
Kaunas, Lithuania, 50009
United Kingdom
Chiswick, United Kingdom, W4 3JL
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01973231     History of Changes
Other Study ID Numbers: NN2211-3867, 2012-004984-27, U1111-1136-3644
Study First Received: October 23, 2013
Last Updated: May 14, 2014
Health Authority: Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Ministry of Health, Social and Family Affairs
Italy: Ministry of Health
Latvia: State Agency of Medicines
Lithuania: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Metformin
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 19, 2014