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Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01766778
First received: January 9, 2013
Last updated: April 7, 2017
Last verified: April 2017
  Purpose
The purpose of this study was to observe change of HbA1c over time from baseline to month 12. The ultimate goal of this study was to provide a local reference value to the physicians & patients in the future when they consider initiating Vildagliptin and taking balance between efficacy, compliance, risk factors, convenience and medication cost.

Condition Intervention Phase
Type-2 Diabetes Mellitus Drug: LAF237 (vildagliptin) Drug: Metformin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Local Phase IV, Multicenter, Open-label Study to Evaluate Early add-on Vildagliptin in Patients With Type 2 Diabetes Inadequately Controlled by Metformin

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12 [ Time Frame: Baseline, Month 12 (weeK 52) ]
    HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c


Secondary Outcome Measures:
  • Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis) [ Time Frame: Baseline, Month 3, 6, 9 and 12 ]
    HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model includes terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by age, pre-existing hypertension and microvascular and macrovascular complications for diabetes mellitus. The variables selected for baseline adjustment were based on the lowest AIC.

  • Change in Fasting Plasma Glucose (FPG) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis) [ Time Frame: Baseline, Month 3, 6, 9 and 12 ]
    Blood samples were collected to analyze fasting plasma glucose. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model included terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by pre-existing hypertension. The variable selected for baseline adjustment was based on the lowest AIC.

  • Percentage of Patients Achieving Good Glycemic Control [ Time Frame: Month 3, 6, 9, 12 ]
    Blood samples were collected to analyze HbA1c. Good glycemic control is defined as patient achieving Hb1Ac < 7.0%. Percentage of patients who achieved HbA1c less than 7.0% at month 3, 6, 9 and 12 were reported for this endpoint.

  • Percentage of Overall Drug Compliance in 12 Months [ Time Frame: Month 12 ]
    The overall drug compliance (%) = (Observed Consumption / Expected Consumption) x 100% Where (Observed Consumption / Expected Consumption) = [1- (Number of missing tablets from all visits/(sum of Allocated Daily Dosage (in tablets) from all visits × No. of Days between the Date Dispensed and the Date Returned))]

  • Number of Patients With Adverse Events, Serious Adverse Events and Death as an Assessment of Overall Safety and Tolerability [ Time Frame: Month 12 ]
    This analysis reported percentage patients with adverse events and patient discontinued from the study due to adverse events. Aslo, percentage of patients with serious adverse events and death was reported.


Enrollment: 117
Actual Study Start Date: May 13, 2013
Study Completion Date: October 22, 2015
Primary Completion Date: October 22, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LAF237 (vildagliptin) 50mg once daily (QD)
Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
Drug: LAF237 (vildagliptin)
Vildagliptin 50mg capsule
Other Name: LAF237
Drug: Metformin
Metformin maximum tolerance dose
Active Comparator: LAF237 (vildagliptin) 50mg twice daily (BID)
Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
Drug: LAF237 (vildagliptin)
Vildagliptin 50mg capsule
Other Name: LAF237
Drug: Metformin
Metformin maximum tolerance dose

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766778

Locations
Hong Kong
Novartis Investigative Site
Hong Kong SAR, Hong Kong
Novartis Investigative Site
HongKong, Hong Kong
Novartis Investigative Site
Tuen Mun, Hong Kong
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01766778     History of Changes
Other Study ID Numbers: CLAF237AHK01
Study First Received: January 9, 2013
Results First Received: February 23, 2017
Last Updated: April 7, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
type-2 diabetes mellitus, inadequately controlled Metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017