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JanUmet Before Insulin Lantus In Eastern Population Evaluation Program (JUBILEE) In Type 2 Diabetic Patients

NCT01269996 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2015-08-24

No results posted yet for this study

Summary

To evaluate the efficacy and safety of a new treatment regimen of metformin plus sitagliptin (Janumet) followed by a long-acting basal insulin (Lantus) treatment compared to the usual treatment regimen of metformin followed by sulfonylurea and intermediate-acting basal insulin in Type 2 Diabetes Mellitus patients.

Conditions

Interventions

DRUG

Janumet, Lantus

In this multicentre, randomized, open-label prospective study. Recruited patients will be randomized to one of the two treatment groups. Treatment efficacy and safety in terms of HbA1c control and hypoglycemic events will be evaluated. Treatment groups: Group 1 - Metformin followed by Sulfonylurea (Gliclazide) and supplementary intermediate-acting insulin (Protaphane) injection. Group 2 - Janumet followed by Lantus insulin injection.

DRUG

metformin, gliclazide, protaphane

In this multicentre, randomized, open-label prospective study. Recruited patients will be randomized to one of the two treatment groups. Treatment efficacy and safety in terms of HbA1c control and hypoglycemic events will be evaluated. Treatment groups: Group 1 - Metformin followed by Sulfonylurea (Gliclazide) and supplementary intermediate-acting insulin (Protaphane) injection. Group 2 - Janumet followed by Lantus insulin injection.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Juliana CN CHAN, FRCP, MD · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-07-31
Completion
2015-02-28

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

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 NCT01269996 on ClinicalTrials.gov