Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type II Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— VIDA  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01862263
• Other study ID #: CLAF237AMX01
• Status: Terminated
• Phase: Phase 4
• Start date: May 2013
• Est. completion date: July 2015

Study information

• Verified date: June 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 191
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Vildagliptin
Orally active and highly selective inhibitor of DPP-4
• Insulin
Long- acting human insulin analog indicated to improve glycemic control
• Placebo
Matching placebo of vildagliptin

Locations

Country	Name	City	State
Mexico	Novartis Investigative Site	Cancun	Quintana Roo
Mexico	Novartis Investigative Site	Celaya	Guanajuato
Mexico	Novartis Investigative Site	Culiacán	Sinaloa
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Metepec	Estado De México
Mexico	Novartis Investigative Site	Mexico	Distrito Federal
Mexico	Novartis Investigative Site	Mexico	Distrito Federal
Mexico	Novartis Investigative Site	Mexico	Distrito Federal
Mexico	Novartis Investigative Site	Monterrey	Nuevo Leon
Mexico	Novartis Investigative Site	Monterrey	Nuevo León
Mexico	Novartis Investigative Site	Puebla

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with hyperglycemic events evaluated with CGM	An hypoglycemic event is defined as any continuous glucose monitoring (CGM) measurement less than 60 mg/dL and a hyperglycemic is define as any CGM greater than 140 mg/dL.	At 13 weeks
Secondary	Number of hypoglycemia and/or hyperglycemia measured by CGM	An episode of hypoglycemia is defined as any value of glucose under 60 mg/dL, an episode of hyperglycemia is defined as any value of glucose above 140mg/dL measured by CGM.	13 weeks
Secondary	Area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day	Duration and intensity of hypoglycemic episodes, measured as area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day, measured by continuous glucose monitoring	0 to 24 hours daily for week 1, 4 and 13
Secondary	Average of insulin units per day administered during the study	Change from baseline	13 weeks
Secondary	Changes from the baseline in Lipid Profile	Lipid Profile will include total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol	Baseline, 13 weeks
Secondary	Change from baseline in Body weight	Weight will be measured on Kg.	Baseline, 13 weeks
Secondary	Change from baseline in Blood pressure (BP),	BP will be mesured on mmHg	Baseline, 13 weeks
Secondary	Change from baseline in Fasting plasma glucose (FPG),	FPG will be measured on mg/dL	Baseline, 13 weeks
Secondary	Change from baseline in Hemoglobin A1C (HbA1c)	HbA1c will be measured on %	Baseline, 13 weeks
Secondary	Change from baseline in Creatinine	Creatinine will be measured on mg/dL	Baseline, 13 weeks
Secondary	Change from baseline in C-peptide	C-Peptide will be measured on microIU/mL	Baseline, 13 weeks
Secondary	Changes from baseline in alanine aminotransferase (ALT)/aspartate aminotransferase (AST)	ALT/AST will be measured on ratio.	Baseline, 13 week
Secondary	Changes from baseline in Direct bilirubin	Bilirubin will be measure on mg/dL	Baseline, 13 weeks
Secondary	Changes from baseline in Body Mass Index (BMI)		Baseline, 13 weeks
Secondary	Number of patients with adverse events, serious adverse events and death as evaluation of safety and tolerability of coadministration of vildagliptin with insulin		13 weeks