Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin (LIRA-SWITCH™)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Novo Nordisk A/S
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01907854
First received: July 22, 2013
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Change in body weight [ Time Frame: Baseline, week 26 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose [ Time Frame: Baseline, week 26 ] [ Designated as safety issue: No ]
  • Change in fasting blood lipids [ Time Frame: Baseline, week 26 ] [ Designated as safety issue: No ]
  • Change in systolic blood pressure and diastolic blood pressure [ Time Frame: Baseline, week 26 ] [ Designated as safety issue: No ]
  • Subjects who achieve HbA1c below 7.0% (53 mmol/mol) (American Diabetes Association target) (y/n) [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
  • Number of treatment emergent adverse events [ Time Frame: During 26 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 396
Study Start Date: December 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: liraglutide + metformin + sitagliptin placebo 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 subcutaneously (s.c., under the skin) once daily + metformin tablets (at least 1000 mg/day)
Drug: placebo
Sitagliptin placebo tablets once-daily
Active Comparator: sitagliptin + metformin + liraglutide placebo Drug: sitagliptin
100 mg/day sitagliptin tablets once-daily + metformin (at least 1000 mg/day)
Drug: placebo
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 subcutaneously (s.c., under the skin) once daily

  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 type 2 diabetes and treated with metformin equal to or above 1500 mg/day (or maximum tolerated dose equal to or above 1000 mg/day) and sitagliptin 100 mg/day, both at a stable dose for at least 90 days prior to screening. Stable is defined as unchanged medication and dose
  • HbA1c 7.5% - 9.5% (58 mmol/mol - 80 mmol/mol) (both inclusive)
  • Body mass index equal to or above 20 kg/m^2

Exclusion Criteria:

  • Any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol
  • Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. An exception is short-term treatment (equal to or less than 7 days in total) with insulin in connection with intercurrent illness
  • Female who is pregnant, breast-feeding, intends to become pregnant or of child-bearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulations or practice)
  • 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 or multiple endocrine neoplasia syndrome type 2
  • Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
  • Impaired liver function, defined as alanine aminotransferase equal to or above 2.5 times upper normal limit
  • Impaired renal function defined as estimated glomerular filtration rate 60 mL/min/1.73 m^2 per modification of diet in renal disease formula
  • Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
  • Heart failure, New York Heart Association class IV
  • Uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg)
  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: NCT01907854

Contacts
Contact: Novo Nordisk clinicaltrials@novonordisk.com

  Show 65 Study Locations
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: NCT01907854     History of Changes
Other Study ID Numbers: NN2211-4059, 2012-004931-22, U1111-1136-2073, CTRI/2014/05/004623
Study First Received: July 22, 2013
Last Updated: July 17, 2014
Health Authority: Canada: Health Canada
Hungary: Ministry of Health, Social and Family Affairs
India: Drugs Controller General of India
Israel: Ministry of Health
Spain: Spanish Agency of Medicines
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon-Like Peptide 1
Liraglutide
Metformin
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 22, 2014