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

NCT01862263 | Terminated Phase 4 DMC

• 1 other identifier: CLAF237AMX01
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 13

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes,; Type 2 diabetes,; Diabetes mellitus,; insulin,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Number of hypoglycemia and/or hyperglycemia measured by CGM

  13 weeks

• Area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day

  0 to 24 hours daily for week 1, 4 and 13

• Average of insulin units per day administered during the study

  13 weeks

• Changes from the baseline in Lipid Profile

  Baseline, 13 weeks

• Change from baseline in Body weight

  Baseline, 13 weeks

Study Arms (2)

Vildagliptin

EXPERIMENTAL

Vildagliptin 50 mg twice daily (bid) + Insulin 20 to 40 IU/day

Drug: Vildagliptin; Drug: Insulin

Placebo

PLACEBO COMPARATOR

Insulin 20 to 40 IU/day + Vildagliptin Placebo twice daily (bid)

Drug: Insulin; Drug: Placebo

Interventions

Vildagliptin DRUG

Orally active and highly selective inhibitor of DPP-4

Vildagliptin

Insulin DRUG

Long- acting human insulin analog indicated to improve glycemic control

Placebo; Vildagliptin

Placebo DRUG

Matching placebo of vildagliptin

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent read and signed before any protocol procedure.
• Free will to sign the informed consent.
• 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.
• Type 2 diabetes mellitus
• 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.
• HbA1c between 7.5 to 9%.
• Fasting plasma glucose (FPG) less than 270 mg/dL.
• Body mass index (BMI) between 20 to 35 kg/m2.
• Free willing to take the vildagliptin tablets during the study.

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (13)

Novartis Investigative Site

Celaya, Guanajuato, 38000, Mexico

Location

Novartis Investigative Site

Guadalajara, Jalisco, 44150, Mexico

Location

Novartis Investigative Site

Guadalajara, Jalisco, 44600, Mexico

Location

Novartis Investigative Site

Guadalajara, Jalisco, 44670, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 06700, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 07300, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico City, 14050, Mexico

Location

Novartis Investigative Site

Monterrey, Nuevo León, 64020, Mexico

Location

Novartis Investigative Site

Monterrey, Nuevo León, 64710, Mexico

Location

Novartis Investigative Site

Cancún, Quintana Roo, 77500, Mexico

Location

Novartis Investigative Site

Culiacán, Sinaloa, 80000, Mexico

Location

Novartis Investigative Site

Metepec, State of Mexico, 52140, Mexico

Location

Novartis Investigative Site

Puebla City, 72190, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Interventions

Vildagliptin; Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 24, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 5, 2019

Record last verified: 2019-06

Locations

ME (13)