NCT01518101

Brief Summary

Dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagonlike peptide-1 (GLP-1) mimetics or analogs, which rely on the gastrointestinal hormones that are part of the incretin system for the treatment of T2DM, provide a therapeutic alternative to common oral antihyperglycemic agents (eg, sulfonylureas, thiazolidinediones). Although GLP-1 analogs and DPP-4 inhibitor medications are effective, there are differences between these products, including method of administration (injectable versus oral). Previous studies have shown that patients prefer additional oral agents over injectable agents because of fear of injections and the desire to avoid them. Patient preference is both clinically and financially important, as it can have long-term implications in terms of patients' motivation and insight into their disease state and its treatment, which might have a direct impact on the patient's compliance and treatment adherence. The aim of the current study is to evaluate the proportion of T2DM patients preferring oral anti-diabetic treatment with vildagliptin + metformin versus an injectable anti-diabetic treatment with liraglutide after 4 weeks of treatment with each medication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_4 type-2-diabetes

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

January 22, 2012

Last Update Submit

February 23, 2017

Conditions

Type 2 Diabetes

Keywords

patient preferencevildagliptinliraglutide

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients preferring each treatment regimen

    Individual patient preference will be assessed by a two-choice question.

    At week 24

Secondary Outcomes (6)

  • Number of patients with treatment satisfaction for each treatment measured by Diabetes Treatment Satisfaction Questionnaire (TSQM-9)

    week 12, Week 24

  • Number of patients responding to subjective reasons of preference to each treatment

    Week 12, week 24

  • Number of patients with adverse event, serious adverse events and death

    24 weeks

  • Change from baseline in fasting plasma glucose at 12 weeks and 24 weeks

    From Baseline to 12 weeks and 24 weeks

  • Change From Baseline in Hemoglobin A1c (HbA1c) at week 12 and week 24

    From Baseline to 12 weeks and 24 weeks

  • +1 more secondary outcomes

Study Arms (2)

Vildagliptin/Metformin followed by Liraglutide+Metformin

EXPERIMENTAL

In period I, Patients receiving vildagliptin will receive a stable dose of 50mg vildagliptin bid (twice daily) + 1000mg metformin bid for 12 weeks. In period II, patients will receive 0.6mg liraglutide od (once daily) + 1000mg metformin bid for the first week (week 13 - week 14) and increase the dose after 7 days up to 1.2mg liraglutide od/1000mg metformin bid.

Drug: Vildagliptin/ MetforminDrug: LiraglutideDrug: Metformin

Liraglutide + Metformin followed by Vildagliptin/Metformin

EXPERIMENTAL

In period I, patients will receive 0.6mg liraglutide od (once daily) + 1000mg metformin bid (twice daily) for the first week (week 0 - week 1) and increase the dose after 7 days up to 1.2mg liraglutide od/1000mg metformin bid (week 2 -12). In period II, patients will receive a stable dose of 50mg vildagliptin bid (twice daily) + 1000mg metformin bid for next 12 weeks.

Drug: Vildagliptin/ MetforminDrug: LiraglutideDrug: Metformin

Interventions

Vildagliptin/ MetforminDRUG

Single pill combination of Vildagliptin/ Metformin (50/1000 mg).

Liraglutide + Metformin followed by Vildagliptin/MetforminVildagliptin/Metformin followed by Liraglutide+Metformin
LiraglutideDRUG

1.2 mg once daily by commercially available injection pens

Liraglutide + Metformin followed by Vildagliptin/MetforminVildagliptin/Metformin followed by Liraglutide+Metformin
MetforminDRUG

1000 mg tablets twice daily

Liraglutide + Metformin followed by Vildagliptin/MetforminVildagliptin/Metformin followed by Liraglutide+Metformin

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 2 diabetes
  • Metformin monotherapy \> 12 weeks
  • Hemoglobin A1c (HbA1c) \> 6.5 % and \< 9.0 %
  • Body mass Index (BMI) 19-35 (kg/m²)

You may not qualify if:

  • acute diseases at randomization
  • kidney diseases with creatinin \> 120 µmol/l, glomerular filtration rate (GFR) \<50 ml/min
  • contraindication for Gliptins or glucagon-like-peptide-analogues according to the respective Summary of Product Characteristics (SmPC)
  • previous use of dipeptidyl peptidase-4-inhibitors and GLP-1-mimetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Novartis Investigative Site

Völlkingen, Germany, 66333, Germany

Location

Novartis Investigative Site

Berlin, 10115, Germany

Location

Novartis Investigative Site

Berlin, 13055, Germany

Location

Novartis Investigative Site

Dortmund, 44137, Germany

Location

Novartis Investigative Site

Falkensee, 14612, Germany

Location

Novartis Investigative Site

Meissen, 01662, Germany

Location

Novartis Investigative Site

Neunkirchen, 57290, Germany

Location

Novartis Investigative Site

Saarlouis, 66740, Germany

Location

Related Publications (1)

  • Ludemann J, Dutting ED, Dworak M. Patient preference and tolerability of a DPP-4 inhibitor versus a GLP-1 analog in patients with type 2 diabetes mellitus inadequately controlled with metformin: a 24-week, randomized, multicenter, crossover study. Ther Adv Endocrinol Metab. 2015 Aug;6(4):141-8. doi: 10.1177/2042018815595584.

    PMID: 26301063RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Patient Preference

Interventions

VildagliptinMetforminLiraglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient SatisfactionTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiguanidesGuanidinesAmidinesGlucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2012

First Posted

January 25, 2012

Study Start

January 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations

DE(8)