Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride

NCT02007278 | Completed Phase 4 Results

• 1 other identifier: CLAF237ACO01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study was to compare the effect of a fixed dose combination of vildagliptin plus metformin versus combination therapy of glimepiride plus metformin in glycemic variability in patients with type 2 diabetes who have not achieved adequate control of their disease prior to treatment with metformin monotherapy in optimal doses.

Conditions

Type 2 Diabetes; Hypoglycemia

Keywords

diabetes; hypoglycemia; glycemic variability; vildagliptin; glimepiride

Outcome Measures

Primary Outcomes (1)

• Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE)

  Mean Amplitude of Glycemic Excursions (MAGE) , which determines the average blood glucose excursions either above or below a value of one standard deviation of the average value of glucose in a given day. MAGE is calculated from the data of continuous tissue glucose monitoring obtained during the measurement period. MAGE is calculated with the formula Σ λ / χ if λ\> ν (where λ = changes in blood glucose from peak to nadir, χ = number of valid observations, ν = 1 standard deviation of the mean glucose during a period of 24 hours) from the data of continuous monitoring of the tissue glucose, obtained during the period of measurement.

  Week 12

Secondary Outcomes (7)

• Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA)

  Week 12

• Glycemic Variability Measured by Total Standard Deviation (TSD)

  Week 12

• Percentage of Patients Who Achieved a Decrease Equal to or Greater Than 0.3% in Value of HbA1c at Week 12

  Screening visit , 12 weeks of treatment

• Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline

  baseline, 12 weeks of treatment

• Number of Patients With Incidence of Hypoglycemia

  12 weeks

Study Arms (2)

vildagliptin and metformin

ACTIVE COMPARATOR

Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks

Drug: vildagliptin and metformin (combination)

glimepiride and metformin

ACTIVE COMPARATOR

Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin

Drug: glimepiride; Drug: Metformin

Interventions

vildagliptin and metformin (combination) DRUG

vildagliptin and metformin combination therapy as 50mg/850mg bid or 50mg/1000mg bid

vildagliptin and metformin

glimepiride DRUG

glimepiride and metformin

Metformin DRUG

glimepiride and metformin

Eligibility Criteria

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

You may qualify if:

• HbA1c between 8%-10.5% in stable metformin dose (\>1500 mg/day), four weeks prior visit 1

You may not qualify if:

• Use of other antidiabetic oral therapy during the last 3 months (sulphonylurea, glitazones, GLP-1 analogues, DPP-4 inhibitors), except metformin

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

Novartis Investigative Site

Medellín, Antioquia, Colombia

Location

Novartis Investigative Site

Manizales, Caldas Department, 1700, Colombia

Location

Novartis Investigative Site

Cali, Colombia, Colombia

Location

Novartis Investigative Site

Bogotá, Cundinamarca, Colombia

Location

Novartis Investigative Site

Chía, Cundinamarca, 11001000, Colombia

Location

Novartis Investigative Site

Cali, Valle del Cauca Department, 760001, Colombia

Location

Novartis Investigative Site

Bogotá, 00000, Colombia

Location

Novartis Investigative Site

Montería, Colombia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia; Diabetes Mellitus

Interventions

Vildagliptin; Metformin; glimepiride

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; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 10, 2013
• Study Start: January 3, 2014
• Primary Completion: February 22, 2016
• Study Completion: February 22, 2016
• Last Updated: July 11, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-04

Locations

CO (8)