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

  Hide Study Locations
Locations
United States, Arizona
Novo Nordisk Clinical Trial Call Center Recruiting
Phoenix, Arizona, United States, 85018
Novo Nordisk Clinical Trial Call Center Recruiting
Phoenix, Arizona, United States, 85027
Novo Nordisk Clinical Trial Call Center Recruiting
Tucson, Arizona, United States, 85724
Novo Nordisk Clinical Trial Call Center Recruiting
Tucson, Arizona, United States, 85704
United States, California
Novo Nordisk Clinical Trial Call Center Recruiting
Escondido, California, United States, 92026
Novo Nordisk Clinical Trial Call Center Recruiting
Fair Oaks, California, United States, 95628
Novo Nordisk Clinical Trial Call Center Recruiting
Mission Viejo, California, United States, 92691
United States, Colorado
Novo Nordisk Clinical Trial Call Center Recruiting
Colorado Springs, Colorado, United States, 80922
Novo Nordisk Clinical Trial Call Center Recruiting
Colorado Springs, Colorado, United States, 80909
United States, Florida
Novo Nordisk Clinical Trial Call Center Recruiting
Chiefland, Florida, United States, 32626
Novo Nordisk Clinical Trial Call Center Recruiting
Fort Lauderdale, Florida, United States, 33308
Novo Nordisk Clinical Trial Call Center Recruiting
Hialeah, Florida, United States, 33012
Novo Nordisk Clinical Trial Call Center Recruiting
Jacksonville, Florida, United States, 32216
Novo Nordisk Clinical Trial Call Center Recruiting
Jacksonville, Florida, United States, 32258
Novo Nordisk Clinical Trial Call Center Recruiting
Jacksonville, Florida, United States, 32207
Novo Nordisk Clinical Trial Call Center Recruiting
Miami, Florida, United States, 33183
Novo Nordisk Clinical Trial Call Center Recruiting
North Miami, Florida, United States, 33181
Novo Nordisk Clinical Trial Call Center Recruiting
Port Charlotte, Florida, United States, 33952
United States, Georgia
Novo Nordisk Clinical Trial Call Center Recruiting
Johns Creek, Georgia, United States, 30097
United States, Hawaii
Novo Nordisk Clinical Trial Call Center Recruiting
Honolulu, Hawaii, United States, 96813
United States, Idaho
Novo Nordisk Clinical Trial Call Center Recruiting
Blackfoot, Idaho, United States, 83221
United States, Illinois
Novo Nordisk Clinical Trial Call Center Recruiting
Arlington Heights, Illinois, United States, 60005-4144
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Chicago, Illinois, United States, 60604
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Peoria, Illinois, United States, 61602
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Skokie, Illinois, United States, 60077
United States, Indiana
Novo Nordisk Clinical Trial Call Center Recruiting
Avon, Indiana, United States, 46123-7877
Novo Nordisk Clinical Trial Call Center Recruiting
Evansville, Indiana, United States, 47714
Novo Nordisk Clinical Trial Call Center Recruiting
Evansville, Indiana, United States, 47725
United States, Iowa
Novo Nordisk Clinical Trial Call Center Recruiting
Council Bluffs, Iowa, United States, 51501-3605
United States, Maine
Novo Nordisk Clinical Trial Call Center Recruiting
Bangor, Maine, United States, 04401
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center Recruiting
Fall River, Massachusetts, United States, 02720
United States, Michigan
Novo Nordisk Clinical Trial Call Center Recruiting
Troy, Michigan, United States, 48085-5524
United States, Missouri
Novo Nordisk Clinical Trial Call Center Recruiting
St. Peters, Missouri, United States, 63376
United States, Nevada
Novo Nordisk Clinical Trial Call Center Recruiting
Las Vegas, Nevada, United States, 89119
United States, New Hampshire
Novo Nordisk Clinical Trial Call Center Recruiting
Nashua, New Hampshire, United States, 03063
United States, New Jersey
Novo Nordisk Clinical Trial Call Center Recruiting
Berlin, New Jersey, United States, 08009
Novo Nordisk Clinical Trial Call Center Recruiting
Elizabeth, New Jersey, United States, 07202
United States, New York
Novo Nordisk Clinical Trial Call Center Recruiting
Albany, New York, United States, 12206
United States, North Carolina
Novo Nordisk Clinical Trial Call Center Recruiting
Charlotte, North Carolina, United States, 28210-0106
Novo Nordisk Clinical Trial Call Center Recruiting
Salisbury, North Carolina, United States, 28144
United States, Ohio
Novo Nordisk Clinical Trial Call Center Recruiting
Akron, Ohio, United States, 44260
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center Recruiting
Reading, Pennsylvania, United States, 19606
United States, South Carolina
Novo Nordisk Clinical Trial Call Center Recruiting
Moncks Corner, South Carolina, United States, 29461
Novo Nordisk Clinical Trial Call Center Recruiting
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
Novo Nordisk Clinical Trial Call Center Recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
Novo Nordisk Clinical Trial Call Center Recruiting
Edinburg, Texas, United States, 78539
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Fort Worth, Texas, United States, 76104
Novo Nordisk Clinical Trial Call Center Recruiting
Houston, Texas, United States, 77030-2324
Novo Nordisk Clinical Trial Call Center Recruiting
Houston, Texas, United States, 77024
Novo Nordisk Clinical Trial Call Center Recruiting
Houston, Texas, United States, 77079
Novo Nordisk Clinical Trial Call Center Recruiting
Houston, Texas, United States, 77036
Novo Nordisk Clinical Trial Call Center Recruiting
Houston, Texas, United States, 77070
Novo Nordisk Clinical Trial Call Center Recruiting
Midland, Texas, United States, 79707
Novo Nordisk Clinical Trial Call Center Recruiting
New Braunfels, Texas, United States, 78130
Novo Nordisk Clinical Trial Call Center Recruiting
North Richland Hills, Texas, United States, 76180
Novo Nordisk Clinical Trial Call Center Recruiting
San Antonio, Texas, United States, 78212
Novo Nordisk Clinical Trial Call Center Recruiting
Sugarland, Texas, United States, 77478
United States, Virginia
Novo Nordisk Clinical Trial Call Center Recruiting
Virginia Beach, Virginia, United States, 23454
United States, Washington
Novo Nordisk Clinical Trial Call Center Recruiting
Spokane, Washington, United States, 99202-3649
Canada, Ontario
Recruiting
Toronto, Ontario, Canada, M9V 4B4
Hungary
Recruiting
Eger, Hungary, 3300
India
Recruiting
Visakhapatnam, Andhra Pradesh, India, 530002
Israel
Recruiting
Herzliya, Israel, 46851
Puerto Rico
Novo Nordisk Clinical Trial Call Center Recruiting
San Juan, Puerto Rico, 00921
Spain
Recruiting
Sevilla, Spain, 41009
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 23, 2014