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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01907854
First received: July 22, 2013
Last updated: December 15, 2016
Last verified: December 2016
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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: From baseline to week 26 ]
    Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM).


Secondary Outcome Measures:
  • Change in Body Weight [ Time Frame: From baseline to week 26 ]
    Change from baseline in body weight was analysed after 26 weeks of treatment. Analysis population set: FAS: all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM.

  • Change in Fasting Plasma Glucose [ Time Frame: From baseline to week 26 ]
    Change from baseline in fasting plasma glucose was analysed after 26 weeks of treatment. Missing values were imputed using MMRM.

  • Change in Fasting Blood Lipids [ Time Frame: From baseline to week 26 ]
    Ratio to baseline in fasting blood lipids (total cholesterol, low density lipoprotein [LDL], very low density lipoprotein [VLDL], high density lipoprotein [HDL], triglycerides, and free fatty acids) were analysed after 26 weeks treatment. Missing values were imputed using MMRM. Here we are presenting ratio to baseline data.

  • Change in Systolic Blood Pressure and Diastolic Blood Pressure [ Time Frame: From baseline to week 26 ]
    Change from baseline in systolic and diastolic blood pressure were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.

  • Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n) [ Time Frame: After 26 weeks of treatment ]
    Number of subjects who achieve HbA1c <7.0% were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.

  • Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: During 26 weeks of treatment plus one week follow-up period. ]
    A treatment emergent adverse event (TEAE) was defined as an event that had an onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. The number of TEAEs was recorded during 26 weeks of treatment plus one week follow-up period.


Enrollment: 407
Study Start Date: December 2013
Study Completion Date: June 2015
Primary Completion Date: June 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
Experimental: Sitagliptin + metformin + liraglutide placebo Drug: sitagliptin
100 mg/day sitagliptin tablets once-daily + metformin (at least 1000 mg/day)
Drug: placebo
Sitagliptin placebo tablets once-daily

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Hide Study Locations
Locations
United States, Arizona
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85018
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85027
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85704
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85724
United States, California
Novo Nordisk Investigational Site
Escondido, California, United States, 92025
Novo Nordisk Investigational Site
Mission Viejo, California, United States, 92691
Novo Nordisk Investigational Site
Roseville, California, United States, 95661
United States, Colorado
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80909
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80922
United States, Florida
Novo Nordisk Investigational Site
Chiefland, Florida, United States, 32626
Novo Nordisk Investigational Site
Fort Lauderdale, Florida, United States, 33308
Novo Nordisk Investigational Site
Hialeah, Florida, United States, 33012
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32207
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32216
Novo Nordisk Investigational Site
Jacksonville, Florida, United States, 32258
Novo Nordisk Investigational Site
Miami, Florida, United States, 33183
Novo Nordisk Investigational Site
North Miami, Florida, United States, 33181
Novo Nordisk Investigational Site
Port Charlotte, Florida, United States, 33952
United States, Georgia
Novo Nordisk Investigational Site
Johns Creek, Georgia, United States, 30097
United States, Hawaii
Novo Nordisk Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Idaho
Novo Nordisk Investigational Site
Blackfoot, Idaho, United States, 83221
United States, Illinois
Novo Nordisk Investigational Site
Arlington Heights, Illinois, United States, 60005-4144
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60604
Novo Nordisk Investigational Site
Peoria, Illinois, United States, 61602
Novo Nordisk Investigational Site
Skokie, Illinois, United States, 60077
United States, Indiana
Novo Nordisk Investigational Site
Avon, Indiana, United States, 46123
Novo Nordisk Investigational Site
Evansville, Indiana, United States, 47714
Novo Nordisk Investigational Site
Evansville, Indiana, United States, 47725
United States, Iowa
Novo Nordisk Investigational Site
Council Bluffs, Iowa, United States, 51501
United States, Maine
Novo Nordisk Investigational Site
Bangor, Maine, United States, 04401
United States, Massachusetts
Novo Nordisk Investigational Site
Fall River, Massachusetts, United States, 02720
United States, Michigan
Novo Nordisk Investigational Site
Troy, Michigan, United States, 48085-5524
United States, Missouri
Novo Nordisk Investigational Site
St. Peters, Missouri, United States, 63376
United States, Nevada
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89119
United States, New Hampshire
Novo Nordisk Investigational Site
Nashua, New Hampshire, United States, 03063
United States, New Jersey
Novo Nordisk Investigational Site
Berlin, New Jersey, United States, 08009
Novo Nordisk Investigational Site
Elizabeth, New Jersey, United States, 07202
United States, New York
Novo Nordisk Investigational Site
Albany, New York, United States, 12206
United States, North Carolina
Novo Nordisk Investigational Site
Charlotte, North Carolina, United States, 28210-0106
Novo Nordisk Investigational Site
Salisbury, North Carolina, United States, 28144
United States, Ohio
Novo Nordisk Investigational Site
Akron, Ohio, United States, 44311
United States, Pennsylvania
Novo Nordisk Investigational Site
Reading, Pennsylvania, United States, 19606
United States, South Carolina
Novo Nordisk Investigational Site
Moncks Corner, South Carolina, United States, 29461
Novo Nordisk Investigational Site
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
Novo Nordisk Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Novo Nordisk Investigational Site
Edinburg, Texas, United States, 78539
Novo Nordisk Investigational Site
Fort Worth, Texas, United States, 76104
Novo Nordisk Investigational Site
Houston, Texas, United States, 77024
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030
Novo Nordisk Investigational Site
Houston, Texas, United States, 77036
Novo Nordisk Investigational Site
Houston, Texas, United States, 77079
Novo Nordisk Investigational Site
Midland, Texas, United States, 79707
Novo Nordisk Investigational Site
New Braunfels, Texas, United States, 78130
Novo Nordisk Investigational Site
North Richland Hills, Texas, United States, 76180
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78245
Novo Nordisk Investigational Site
Sugar Land, Texas, United States, 77478
United States, Virginia
Novo Nordisk Investigational Site
Virginia Beach, Virginia, United States, 23454
United States, Washington
Novo Nordisk Investigational Site
Spokane, Washington, United States, 99202-3649
Canada, British Columbia
Novo Nordisk Investigational Site
Surrey, British Columbia, Canada, V3S 2N6
Canada, Ontario
Novo Nordisk Investigational Site
Brampton, Ontario, Canada, L6S 0C9
Novo Nordisk Investigational Site
Burlington, Ontario, Canada, L7M 4Y1
Novo Nordisk Investigational Site
Etobicoke, Ontario, Canada, M9R 4E1
Novo Nordisk Investigational Site
Grimsby, Ontario, Canada, L3M 1P3
Novo Nordisk Investigational Site
Ottawa, Ontario, Canada, K1K 4L2
Novo Nordisk Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
Novo Nordisk Investigational Site
Strathroy, Ontario, Canada, N7G 1Y7
Novo Nordisk Investigational Site
Thornhill, Ontario, Canada, L4J 8L7
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M3J 1N2
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M4G 3E8
Novo Nordisk Investigational Site
Toronto, Ontario, Canada, M9V 4B4
Canada, Quebec
Novo Nordisk Investigational Site
Drummondville, Quebec, Canada, J2B 7T1
Novo Nordisk Investigational Site
St. Romuald, Quebec, Canada, G6W 5M6
Novo Nordisk Investigational Site
Trois Rivières, Quebec, Canada, G8T 7A1
Novo Nordisk Investigational Site
Westmount, Quebec, Canada, H3Z 1E5
Canada
Novo Nordisk Investigational Site
Quebec, Canada, G3K 2P8
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, 1042
Novo Nordisk Investigational Site
Debrecen, Hungary, 4043
Novo Nordisk Investigational Site
Eger, Hungary, 3300
Novo Nordisk Investigational Site
Gyula, Hungary, H-5700
Novo Nordisk Investigational Site
Salgótarján, Hungary, 3100
Novo Nordisk Investigational Site
Sopron, Hungary, 9400
Novo Nordisk Investigational Site
Szeged, Hungary, H-6720
Novo Nordisk Investigational Site
Tatabánya, Hungary, 2800
India
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India, 500082
Novo Nordisk Investigational Site
Visakhapatnam, Andhra Pradesh, India, 530002
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India, 380008
Novo Nordisk Investigational Site
Gandhinagar, Gujarat, India, 382428
Novo Nordisk Investigational Site
Bangalore, Karnataka, India, 560002
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400007
Novo Nordisk Investigational Site
Pune, Maharashtra, India, 411040
Novo Nordisk Investigational Site
New Delhi, India, 110060
Israel
Novo Nordisk Investigational Site
Haifa, Israel, 3339419
Novo Nordisk Investigational Site
Haifa, Israel, 35152
Novo Nordisk Investigational Site
Herzliya, Israel, 46851
Novo Nordisk Investigational Site
Kfar Saba, Israel, 44281
Novo Nordisk Investigational Site
Nahariya, Israel, 22100
Novo Nordisk Investigational Site
Ofakim, Israel, 87520
Novo Nordisk Investigational Site
Tel Aviv, Israel, 6937947
Novo Nordisk Investigational Site
Tel-Aviv, Israel, 62038
Puerto Rico
Novo Nordisk Investigational Site
San Juan, Puerto Rico, 00921
Spain
Novo Nordisk Investigational Site
Badalona, Spain, 08916
Novo Nordisk Investigational Site
El Ferrol, Spain, 15405
Novo Nordisk Investigational Site
Granada, Spain, 18003
Novo Nordisk Investigational Site
Málaga, Spain, 29006
Novo Nordisk Investigational Site
Sanlúcar de Barrameda, Spain, 11540
Novo Nordisk Investigational Site
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:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01907854     History of Changes
Other Study ID Numbers: NN2211-4059
2012-004931-22 ( EudraCT Number )
U1111-1136-2073 ( Other Identifier: WHO )
CTRI/2014/05/004623 ( Registry Identifier: Clinical Trial Registry India (CTRI) )
Study First Received: July 22, 2013
Results First Received: May 23, 2016
Last Updated: December 15, 2016

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

ClinicalTrials.gov processed this record on September 21, 2017