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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

NCT01907854 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2018-10-02

Study results available
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Summary

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.

Conditions

Interventions

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

Sitagliptin placebo tablets once-daily

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-02
Primary Completion
2015-06-15
Completion
2015-06-15

Countries

  • United States
  • Canada
  • Hungary
  • India
  • Israel
  • Puerto Rico
  • Spain

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01907854 on ClinicalTrials.gov