Type-2 Diabetes Mellitus | Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin
Type-2 Diabetes Mellitus research study
What is the primary objective of this study?
Who is eligible to participate?
Inclusion Criteria: 1. Male or Female in age ≥18 at Visit 1 2. Type 2 diabetes mellitus (T2DM) patients on their maximum tolerated dose of Metformin for more than 3 months 3. HbA1c (glycosylated hemoglobin) at Visit 1 greater than 7.0% 4. With nearest documented record of HbA1c before Visit 1 greater than 7.0% after patient reached his/her maximum tolerated dose of Metformin Key Exclusion Criteria: 1. Patients with hepatic impairment, including patients with a pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 X the upper limit of normal at Visit 1 2. Patients with moderate or severe renal impairment or end-stage-renal-disease (ESRD) on haemodialysis at the time of enrolment 3. Patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption 4. Pregnant women or breastfeeding women at the time of enrolment 5. Use of insulin or other oral anti-diabetic drug (OAD) apart from Metformin in the past for T2DM treatment
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Type-2 Diabetes Mellitus
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:LAF237 (vildagliptin)Vildagliptin 50mg capsule
Drug:MetforminMetformin maximum tolerance dose
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
LAF237 (vildagliptin) 50mg once daily (QD)Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
LAF237 (vildagliptin) 50mg twice daily (BID)Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
Start Date: May 13, 2013
Completed Date: October 22, 2015
Phase: Phase 4
Primary Outcome: Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12
Secondary Outcome: Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)
Study sponsors, principal investigator, and references
Principal Investigator: Novartis Pharmaceuticals
Lead Sponsor: Novartis Pharmaceuticals