MedDataX Logo

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

NCT ID: NCT02007278

Last Updated: 2017-07-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-03

Study Completion Date

2016-02-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Oral Combination of Glimepiride/Vildagliptin/Metformin in Patients With T2D and Dual Treatment Failure

NCT04841096

Type 2 Diabetes
COMPLETED PHASE3

Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients

NCT01459809

Diabetes Mellitus, Type 2
COMPLETED PHASE3

The Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT Under Fed Conditions

NCT06244407

Healthy Volunteer
NOT_YET_RECRUITING PHASE1

A Study in Patients With Type 2 Diabetes

NCT01408095

Diabetes Mellitus, Type 2
WITHDRAWN PHASE2

Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy

NCT01444248

Type 2 Diabetes Mellitus
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Hypoglycemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

vildagliptin and metformin

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

Group Type ACTIVE_COMPARATOR

vildagliptin and metformin (combination)

Intervention Type DRUG

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

glimepiride and metformin

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

Group Type ACTIVE_COMPARATOR

glimepiride

Intervention Type DRUG

Metformin

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vildagliptin and metformin (combination)

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

Intervention Type DRUG

glimepiride

Intervention Type DRUG

Metformin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Medellín, Antioquia, Colombia

Site Status

Novartis Investigative Site

Manizales, Caldas Department, Colombia

Site Status

Novartis Investigative Site

Cali, Colombia, Colombia

Site Status

Novartis Investigative Site

Bogotá, Cundinamarca, Colombia

Site Status

Novartis Investigative Site

Chía, Cundinamarca, Colombia

Site Status

Novartis Investigative Site

Cali, Valle del Cauca Department, Colombia

Site Status

Novartis Investigative Site

Bogotá, , Colombia

Site Status

Novartis Investigative Site

Montería, , Colombia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Colombia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLAF237ACO01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients
NCT01708902 COMPLETED PHASE3
Bioequivalence Study to Compare Metformin / Vildagliptin (850 mg/50 mg) Versus Galvumet®
NCT06103747 COMPLETED PHASE1
Glimepiride vs Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus
NCT00353691 COMPLETED PHASE3
A Study of GWP42004 as Add on to Metformin in the Treatment of Participants With Type 2 Diabetes
NCT02053272 COMPLETED PHASE2
Study of Metabolic and Haemodynamic Effects of Metformin and Glimepiride in Patients With Type 2 Diabetes Mellitus
NCT01509001 COMPLETED PHASE4
A Research Study to Assess the Mechanism By Which Glucovance, Metformin, and Glyburide Work To Control Glucose Levels In Patients With Type 2 Diabetes
NCT00035568 COMPLETED PHASE4
Effect of Combination of Mitiglinide and Metformin on Glycemic Control in Patients With Type 2 Diabetes Mellitus
NCT01037842 COMPLETED PHASE3
Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes
NCT01512979 COMPLETED PHASE4
Continuous Glucose Monitoring System (CGMS) in Type 2 Diabetic Patients Inadequately Controlled by Metformine Monotherapy; Analyze of Glycemic Profile Before and After Association of Glimepiride
NCT00633425 COMPLETED PHASE4
Mitiglinide in Combination With Metformin vs. Metformin Alone in Patients With Type 2 Diabetes Mellitus
NCT00519142 COMPLETED PHASE3
Phase III Trial to Evaluate the Efficacy and Safety of Gemigliptin 50mg qd Added to Ongoing Glimepiride as Fix-dose Combination in Patients With Type 2 Diabetes
NCT02089126 UNKNOWN PHASE3
Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide
NCT00279045 COMPLETED PHASE3
Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets
NCT06248801 NOT_YET_RECRUITING PHASE1
Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered
NCT01068743 COMPLETED PHASE1
Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled
NCT01699932 COMPLETED PHASE3
Effects of Gemigliptin Versus Sitagliptin or Glimepiride With Metformin on Glucose Variability(MAGE, Glucose SD) Patients With Type 2 DM(STABLE Study)
NCT01890629 COMPLETED PHASE4
Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes
NCT00614120 COMPLETED PHASE3
Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans
NCT01762046 ACTIVE_NOT_RECRUITING PHASE1
Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
NCT02769481 COMPLETED PHASE3
Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
NCT01068717 COMPLETED PHASE1
Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects
NCT00857870 COMPLETED PHASE4
Bioequivalence Study of Vildagliptin From Gliptus 50 mg Tablet (EVA Pharma, Egypt) and Galvus 50 mg Tablet (NOVARTIS PHARMA, GERMANY)
NCT02816970 COMPLETED PHASE1
Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
NCT01438814 COMPLETED PHASE4
Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes
NCT01167881 COMPLETED PHASE3
Observational Study of the Switch of Metformin Alone to Metformin Combined With Repaglinide in Type 2 Diabetes
NCT00709917 COMPLETED