Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments placebo to vildagliptin, vildagliptin, metformin
Phase phase 4
Sponsor Novartis Pharmaceuticals
Start date March 2012
End date April 2019
Trial size 2005 participants
Trial identifier NCT01528254, 2011-003712-23, CLAF237A23156

Summary

The purpose of this study is to determine whether the initiation of a vildagliptin plus metformin combination regimen would result in more durable glycemic control than metformin monotherapy in treatment-naïve patients with T2DM.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
vildagliptin LAF237
Patients will be instructed to take one tablet (50 mg oral) of vildagliptin in the morning and one tablet in the evening with or without food.
metformin
Metformin should be taken in a twice daily (bid) regimen during or after meals at the same time as vildagliptin.
(Experimental)
placebo to vildagliptin
metformin
Metformin should be taken in a twice daily (bid) regimen during or after meals at the same time as vildagliptin.

Primary Outcomes

Measure
Rate of loss in glycemic control over time
time frame: Week 26
Time to initial treatment failure
time frame: 5 years

Secondary Outcomes

Measure
Rate of loss in glycemic control in fasting plasma glucose
time frame: Up to 5 years
Rate of loss in glycemic control in fasting plasma glucose (FPG) during period 2
time frame: up to 5 years
Rate of loss of beta cell function from baseline to end of study ( 5 years)
time frame: From baseline to end of study (5 years)
Number patients with adverse events, death and serious adverse events
time frame: 5 years
Rate of loss in glycemic control in over time
time frame: up to 5 years
Rate of change in insulin sensitivity from baseline to end of study (5 years)
time frame: From baseline to end of study (5 years)

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Type 2 Diabetes Mellitus (T2DM) diagnosed ≤ 24 months ago - glycosylated hemoglobin (HbA1c) ≥6.5% and ≤7.5% at Visit 1 - Treatment-naïve. - Body mass index (BMI) ≥22 and ≤40 kg/m2 at Visit 1 Exclusion Criteria: - Pregnant or nursing (lactating) women - Fasting plasma glucose (FPG) ≥ 270 mg/dL (≥ 15.0 mmol/L) - Previous or current participation in any vildagliptin clinical study. - History of hypersensitivity to dipeptidyl peptidase-4 (DPP-4) inhibitors. - Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study. - Donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period Other protocol-defined inclusion/exclusion criteria may apply

Additional Information

Official title A 5-year Study to Compare the Durability of Glycemic Control of a Combination Regimen With Vildagliptin & Metformin Versus Standard-of-care Monotherapy With Metformin, Initiated in Treatment-naïve Patients With Type 2 Diabetes Mellitus
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Novartis.