Vildagliptin Versus Liraglutide - Patient Preference After Receiving Both Medications

NCT ID: NCT01518101

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-10-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vildagliptin/Metformin followed by Liraglutide+Metformin

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.

Group Type: EXPERIMENTAL

Vildagliptin/ Metformin

Intervention Type: DRUG

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

Liraglutide

Intervention Type: DRUG

1.2 mg once daily by commercially available injection pens

Metformin

Intervention Type: DRUG

1000 mg tablets twice daily

Liraglutide + Metformin followed by Vildagliptin/Metformin

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.

Group Type: EXPERIMENTAL

Vildagliptin/ Metformin

Intervention Type: DRUG

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

Liraglutide

Intervention Type: DRUG

1.2 mg once daily by commercially available injection pens

Metformin

Intervention Type: DRUG

1000 mg tablets twice daily

Interventions

Vildagliptin/ Metformin

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

Intervention Type: DRUG

Liraglutide

1.2 mg once daily by commercially available injection pens

Intervention Type: DRUG

Metformin

1000 mg tablets twice daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Völlkingen, Germany, Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Berlin, , Germany

Novartis Investigative Site

Dortmund, , Germany

Novartis Investigative Site

Falkensee, , Germany

Novartis Investigative Site

Meissen, , Germany

Novartis Investigative Site

Neunkirchen, , Germany

Novartis Investigative Site

Saarlouis, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 26301063 (View on PubMed)

Other Identifiers

2011-003818-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLMF237ADE03

Identifier Type: -

Identifier Source: org_study_id