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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

NCT ID: NCT01907854

Last Updated: 2018-10-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

407 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-02

Study Completion Date

2015-06-15

Brief Summary

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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.

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Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Liraglutide + metformin + sitagliptin placebo

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

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)

placebo

Intervention Type DRUG

Sitagliptin placebo tablets once-daily

Sitagliptin + metformin + liraglutide placebo

Group Type EXPERIMENTAL

sitagliptin

Intervention Type DRUG

100 mg/day sitagliptin tablets once-daily + metformin (at least 1000 mg/day)

placebo

Intervention Type DRUG

Sitagliptin placebo tablets once-daily

Interventions

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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)

Intervention Type DRUG

sitagliptin

100 mg/day sitagliptin tablets once-daily + metformin (at least 1000 mg/day)

Intervention Type DRUG

placebo

Sitagliptin placebo tablets once-daily

Intervention Type DRUG

placebo

Sitagliptin placebo tablets once-daily

Intervention Type DRUG

Eligibility Criteria

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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

* \- 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)

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Phoenix, Arizona, United States

Site Status

Novo Nordisk Investigational Site

Phoenix, Arizona, United States

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Novo Nordisk Investigational Site

Tucson, Arizona, United States

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Novo Nordisk Investigational Site

Tucson, Arizona, United States

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Escondido, California, United States

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Mission Viejo, California, United States

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Roseville, California, United States

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Colorado Springs, Colorado, United States

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Colorado Springs, Colorado, United States

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Chiefland, Florida, United States

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Fort Lauderdale, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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North Miami, Florida, United States

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Port Charlotte, Florida, United States

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Johns Creek, Georgia, United States

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Honolulu, Hawaii, United States

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Blackfoot, Idaho, United States

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Arlington Heights, Illinois, United States

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Chicago, Illinois, United States

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Peoria, Illinois, United States

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Skokie, Illinois, United States

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Avon, Indiana, United States

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Evansville, Indiana, United States

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Evansville, Indiana, United States

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Council Bluffs, Iowa, United States

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Bangor, Maine, United States

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Fall River, Massachusetts, United States

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Troy, Michigan, United States

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City of Saint Peters, Missouri, United States

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Las Vegas, Nevada, United States

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Nashua, New Hampshire, United States

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Berlin, New Jersey, United States

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Elizabeth, New Jersey, United States

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Albany, New York, United States

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Charlotte, North Carolina, United States

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Salisbury, North Carolina, United States

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Akron, Ohio, United States

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Reading, Pennsylvania, United States

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Moncks Corner, South Carolina, United States

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Orangeburg, South Carolina, United States

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Memphis, Tennessee, United States

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Edinburg, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Midland, Texas, United States

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New Braunfels, Texas, United States

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North Richland Hills, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Virginia Beach, Virginia, United States

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Spokane, Washington, United States

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Surrey, British Columbia, Canada

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Brampton, Ontario, Canada

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Burlington, Ontario, Canada

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Concord, Ontario, Canada

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Etobicoke, Ontario, Canada

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Grimsby, Ontario, Canada

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Ottawa, Ontario, Canada

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Sarnia, Ontario, Canada

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Strathroy, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Drummondville, Quebec, Canada

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Montreal, Quebec, Canada

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Saint Romuald, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Québec, , Canada

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Budapest, , Hungary

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Debrecen, , Hungary

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Eger, , Hungary

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Gyula, , Hungary

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Salgótarján, , Hungary

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Sopron, , Hungary

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Szeged, , Hungary

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Tatabánya, , Hungary

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Hyderabad, Andhra Pradesh, India

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Visakhapatnam, Andhra Pradesh, India

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Ahmedabad, Gujarat, India

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Gandhinagar, Gujarat, India

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Bangalore, Karnataka, India

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Mumbai, Maharashtra, India

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Pune, Maharashtra, India

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New Delhi, , India

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Haifa, , Israel

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Haifa, , Israel

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Herzliya, , Israel

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Kfar Saba, , Israel

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Nahariya, , Israel

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Ofakim, , Israel

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Tel Aviv, , Israel

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Tel Aviv, , Israel

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San Juan, , Puerto Rico

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Badalona, , Spain

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Ferrol, , Spain

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Granada, , Spain

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Málaga, , Spain

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Sanlúcar de Barrameda, , Spain

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Seville, , Spain

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Countries

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United States Canada Hungary India Israel Puerto Rico Spain

References

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Bailey TS, Takacs R, Tinahones FJ, Rao PV, Tsoukas GM, Thomsen AB, Kaltoft MS, Maislos M. Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes (LIRA-SWITCH): a randomized, double-blind, double-dummy, active-controlled 26-week trial. Diabetes Obes Metab. 2016 Dec;18(12):1191-1198. doi: 10.1111/dom.12736. Epub 2016 Sep 14.

Reference Type RESULT
PMID: 27381275 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2012-004931-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1136-2073

Identifier Type: OTHER

Identifier Source: secondary_id

CTRI/2014/05/004623

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN2211-4059

Identifier Type: -

Identifier Source: org_study_id

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