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

July 22, 2013
July 17, 2014
December 2013
February 2015   (final data collection date for primary outcome measure)
Change in HbA1c (glycosylated haemoglobin) [ Time Frame: Baseline, week 26 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01907854 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin
Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • 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: sitagliptin
    100 mg/day sitagliptin tablets once-daily + metformin (at least 1000 mg/day)
  • Drug: placebo
    Sitagliptin placebo tablets once-daily
  • 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
  • Experimental: liraglutide + metformin + sitagliptin placebo
    Interventions:
    • Drug: liraglutide
    • Drug: placebo
  • Active Comparator: sitagliptin + metformin + liraglutide placebo
    Interventions:
    • Drug: sitagliptin
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
396
February 2015
February 2015   (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 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)
Both
18 Years and older
No
Contact: Novo Nordisk clinicaltrials@novonordisk.com
United States,   Canada,   Hungary,   India,   Israel,   Puerto Rico,   Spain
 
NCT01907854
NN2211-4059, 2012-004931-22, U1111-1136-2073, CTRI/2014/05/004623
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
July 2014

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