Effect of Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number Type 2 Diabetes

NCT01822548 | Completed Phase 3 Results DMC

• 1 other identifier: 2012-005399-32
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the effect of Dipeptidyl peptidase (DPP) -IV inhibitor Vildagliptin vs. Glibenclamide on circulating endothelial progenitor cells (EPCs) number in type 2 diabetes patients in metformin failure. Subjects will be followed for 12 months after randomization.

Conditions

Type 2 Diabetes

Keywords

EPC; diabetes; DPP IV inhibitors

Outcome Measures

Primary Outcomes (1)

• Absolute Change in the Endothelial Progenitor Cell (EPC) Number

  The study primary endpoint was the change from baseline values of the EPC number in the Vildagliptin vs Glibenclamide arm at 4 and 12 months.

  V0, V2 (month 4), V4 (12 month)

Secondary Outcomes (1)

• Absolute Change in HbA1C Compared to Baseline

  V0 (randomization), V2 (month4), V4 (month 12).

Study Arms (2)

Vildagliptin & metformin

EXPERIMENTAL

Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration

Drug: Vildagliptin; Drug: Metformin

Glibenclamide & metformin

ACTIVE COMPARATOR

Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration

Drug: Glibenclamide; Drug: Metformin

Interventions

Vildagliptin DRUG

100 mg daily

Also known as: LAF237A

Vildagliptin & metformin

Glibenclamide DRUG

2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day.

Glibenclamide & metformin

Metformin DRUG

concomitant therapy with metformin is present in each arm (MAX dose: 2500 mg/die)

Glibenclamide & metformin; Vildagliptin & metformin

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal or above 35 years;
• Diagnosis of type 2 diabetes mellitus as defined by the American Diabetes Association , with at least one year of disease duration at the time of the screening visit;
• Blood glucose lowering treatment with Metformin alone (monotherapy) at a stable dose of at least 1.5 g/day (or maximum tolerated dose) in the 3 months prior to the screening visit;
• Insufficient metabolic control as defined by recent (last six months) HbA1c ≥ 7% in any peripheral laboratory and confirmed at the time of the screening;

You may not qualify if:

• Written informed consent to participate to the study.
• Age below 35 years
• Type 1 diabetes or other causes of diabetes (pancreatectomy, gestational diabetes, etc.)
• HbA1c \< 7% or ≥ 9% at the screening visit
• Treatment with any blood glucose lowering treatment other than Metformin in the six months before screening visit
• BMI \< 20 or ≥ 40 kg/m2, or current/ past history of clinically-relevant eating disorders (including -but no limited to- nervous anorexia, bulimia, binge-eating disorders, etc.)
• Significant progression of diabetic macro-angiopathy or cardiovascular disease in the six months prior to study visit
• Significant progression of diabetic micro-angiopathy in the six months prior to study visit
• Organ failure or other severe diseases limiting life expectancy;
• Beginning, in the three months before screening visit, of any kind of drug which can modify glycemic levels (beta-blockers, diuretics…), or acute disease (acute infection, urinary tract infection…) in three months before screening visit
• History of inflammatory/infective/autoimmune chronic disease
• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, gastric surgery, inflammatory bowel disease;
• Any clinically significant abnormality identified on physical examination, laboratory tests, ECG or vital signs at screening that in the judgment of the investigator would preclude safe completion of the study;
• Uncontrolled or inadequately controlled hypertension at screening (Systolic Blood Pressure (SBP)\>190 or Diastolic Blood Pressure (DBP) \>100 mmHg)
• Ongoing pregnancy or absence of effective contraception in women with childbearing potential

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead

Study Sites (2)

Azienda Opedaliera-Universitaria

Parma, 43126, Italy

Location

Azienda Ospedaliera-Universitaria

Parma, 43126, Italy

Location

Related Publications (1)

• Dei Cas A, Spigoni V, Cito M, Aldigeri R, Ridolfi V, Marchesi E, Marina M, Derlindati E, Aloe R, Bonadonna RC, Zavaroni I. Vildagliptin, but not glibenclamide, increases circulating endothelial progenitor cell number: a 12-month randomized controlled trial in patients with type 2 diabetes. Cardiovasc Diabetol. 2017 Feb 23;16(1):27. doi: 10.1186/s12933-017-0503-0.

  PMID: 28231835 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Vildagliptin; Glyburide; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonylurea Compounds; Urea; Amides; Sulfones; Sulfur Compounds; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Prof.ssa Ivana Zavaroni
• Organization: Azienda ospedaliero-universitaria di Parma

ivana.zavaroni@unipr.it

+390521033306

Study Officials

• Ivana Zavaroni, MD

  Azienda Ospedaliera-Universitaria di Parma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 2, 2013
• Study Start: October 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: August 2, 2017
• Results First Posted: August 2, 2017

Record last verified: 2017-04

Locations

IT (2)