Clinical trial NCT01862263: Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type II Diabetes
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Placebo-Controlled Study to Compare the Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type 2 Diabetes Mellitus Patients Inadequately Controlled With Insulin.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes,
Type 2 diabetes,
Diabetes mellitus,
insulin,
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-05-24
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess if the addition of vildagliptin as add-on therapy improves glucose variability in type 2 diabetes mellitus (T2DM) patients inadequately controlled with insulin, with special emphasis in hypoglycemic episodes measured by continuous glucose monitoring.


Eligibility criteria: Inclusion Criteria:

1. Informed consent read and signed before any protocol procedure.
2. Free will to sign the informed consent.
3. Male and female between 18 and 80 years. If female, patient must be non-fertile or of childbearing potential using a medically approved birth control method.
4. Type 2 diabetes mellitus
5. Patient under insulin treatment within 3 years with stable insulin NPH (Neutral ProtamineHagedorn) regimen at dose of at least 20 UI/day up to 40 UI/day for a minimum of 4 weeks prior to enrolment, only NPH and glargine insulin are allowed.
6. HbA1c between 7.5 to 9%.
7. Fasting plasma glucose (FPG) less than 270 mg/dL.
8. Body mass index (BMI) between 20 to 35 kg/m2.
9. Free willing to take the vildagliptin tablets during the study.

Exclusion Criteria

1. Pregnant or lactating female or without birth control method if of childbearing potential.
2. Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome.
3. Acute cardiovascular complications or metabolic complications within the past 4 months.
4. History cerebrovascular disease during the last year.
5. History of Torsades de Points, ventricular tachycardia or ventricular fibrillation.
6. Ischemic heart disease (e.g. myocardial infarction, unstable angina, coronary artery bypass surgery).
7. Congestive heart failure requiring pharmacologic treatment.
8. Any known serious heart condition.
9. ALT and/or AST greater than three times the upper limit of the normal range.
10. Serum creatinine levels greater than 1.5 mg/dL
11. Malignancy including leukemia and lymphoma within the last 5 years

Other inlcusion/exclusion criteria may apply

Primary outcomes:
measure: Percentage of patients with hyperglycemic events evaluated with CGM
timeFrame: At 13 weeks
Secondary outcomes:
measure: Number of hypoglycemia and/or hyperglycemia measured by CGM
timeFrame: 13 weeks
measure: Area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day
timeFrame: 0 to 24 hours daily for week 1, 4 and 13
measure: Average of insulin units per day administered during the study
timeFrame: 13 weeks
measure: Changes from the baseline in Lipid Profile
timeFrame: Baseline, 13 weeks
measure: Change from baseline in Body weight
timeFrame: Baseline, 13 weeks
measure: Change from baseline in Blood pressure (BP),
timeFrame: Baseline, 13 weeks
measure: Change from baseline in Fasting plasma glucose (FPG),
timeFrame: Baseline, 13 weeks
measure: Change from baseline in Hemoglobin A1C (HbA1c)
timeFrame: Baseline, 13 weeks
measure: Change from baseline in Creatinine
timeFrame: Baseline, 13 weeks
measure: Change from baseline in C-peptide
timeFrame: Baseline, 13 weeks
measure: Changes from baseline in alanine aminotransferase (ALT)/aspartate aminotransferase (AST)
timeFrame: Baseline, 13 week
measure: Changes from baseline in Direct bilirubin
timeFrame: Baseline, 13 weeks
measure: Changes from baseline in Body Mass Index (BMI)
timeFrame: Baseline, 13 weeks
measure: Number of patients with adverse events, serious adverse events and death as evaluation of safety and tolerability of coadministration of vildagliptin with insulin
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Metepec
country: Mexico
facility: Novartis Investigative Site
state: Estado De México
city: Celaya
country: Mexico
facility: Novartis Investigative Site
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Novartis Investigative Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Novartis Investigative Site
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Novartis Investigative Site
state: Nuevo León
city: Cancun
country: Mexico
facility: Novartis Investigative Site
state: Quintana Roo
city: Culiacán
country: Mexico
facility: Novartis Investigative Site
state: Sinaloa
city: Puebla
country: Mexico
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: