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Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes

NCT01930188 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1231

Last updated 2019-06-13

Study results available
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Summary

This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or TZD (thiazolidinedione) in subjects with type 2 diabetes.

Conditions

Interventions

DRUG

semaglutide

For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.

DRUG

sitagliptin

Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.

DRUG

placebo

Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.

DRUG

placebo

For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.

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
2015-10-12
Completion
2015-10-12

Countries

  • Argentina
  • Bulgaria
  • Czechia
  • Hong Kong
  • Hungary
  • India
  • Japan
  • Mexico
  • Norway
  • Portugal
  • Romania
  • Russia
  • South Africa
  • Spain
  • Sweden
  • Thailand
  • Turkey (Türkiye)
  • Ukraine

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 NCT01930188 on ClinicalTrials.gov