Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Type 2 Diabetes Mellitus Patients. (BENEFIT)

November 16, 2016 updated by: Novartis Pharmaceuticals

A Randomized Open-label Study to Compare Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Patients With Type 2 Diabetes Mellitus That do Not Reach Adequate Glycemic Control on Their Current Sulfonylurea Monotherapy.

This study is designed to evaluate safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy to give treating physicians a guidance which additional anti-diabetic treatment can be used if sulfonylurea monotherapy is not sufficient to reach glycemic control.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Anderbeck, Germany, 38836
        • Novartis Investigative Site
      • Augsburg, Germany, 86150
        • Novartis Investigative Site
      • Bad Kreuznach, Germany, 55545
        • Novartis Investigative Site
      • Bad Oeynhausen, Germany, 32549
        • Novartis Investigative Site
      • Balingen, Germany, 72336
        • Novartis Investigative Site
      • Berlin, Germany, 10117
        • Novartis Investigative Site
      • Berlin, Germany, 10115
        • Novartis Investigative Site
      • Berlin, Germany, 12347
        • Novartis Investigative Site
      • Berlin, Germany, 13597
        • Novartis Investigative Site
      • Berlin, Germany, 10627
        • Novartis Investigative Site
      • Berlin, Germany, 13189
        • Novartis Investigative Site
      • Dortmund, Germany, 44137
        • Novartis Investigative Site
      • Dresden, Germany, 01309
        • Novartis Investigative Site
      • Dresden, Germany, 01099
        • Novartis Investigative Site
      • Einbeck, Germany, 37574
        • Novartis Investigative Site
      • Elsterwerda, Germany, 04910
        • Novartis Investigative Site
      • Essen, Germany, 45276
        • Novartis Investigative Site
      • Essen, Germany, 45219
        • Novartis Investigative Site
      • Fulda, Germany, 36037
        • Novartis Investigative Site
      • Gelnhausen, Germany, 63571
        • Novartis Investigative Site
      • Graben-Neudorf, Germany, 76676
        • Novartis Investigative Site
      • Grossheirath-Rossach, Germany, 96269
        • Novartis Investigative Site
      • Herne, Germany, 44653
        • Novartis Investigative Site
      • Hildesheim, Germany, 31139
        • Novartis Investigative Site
      • Kassel, Germany, 34125
        • Novartis Investigative Site
      • Kassel, Germany, 34127
        • Novartis Investigative Site
      • Kleve, Germany, 47533
        • Novartis Investigative Site
      • Koeln, Germany, 51069
        • Novartis Investigative Site
      • Lienen, Germany, 49536
        • Novartis Investigative Site
      • Loehne, Germany, 32584
        • Novartis Investigative Site
      • Lutherstadt Eisleben, Germany, 06295
        • Novartis Investigative Site
      • Magdeburg, Germany, 39120
        • Novartis Investigative Site
      • Mainz, Germany, 55116
        • Novartis Investigative Site
      • Mayen, Germany, 56727
        • Novartis Investigative Site
      • Muenchen, Germany, 80339
        • Novartis Investigative Site
      • Muenchen, Germany, 81373
        • Novartis Investigative Site
      • Mülheim, Germany, 45468
        • Novartis Investigative Site
      • Neubukow, Germany, 18233
        • Novartis Investigative Site
      • Oschatz, Germany, 04758
        • Novartis Investigative Site
      • Potsdam, Germany, 14469
        • Novartis Investigative Site
      • Reinfeld, Germany, 23858
        • Novartis Investigative Site
      • Saarlouis, Germany, 66740
        • Novartis Investigative Site
      • St. Ingbert - Oberwuerzbach, Germany, 66386
        • Novartis Investigative Site
      • Straubing, Germany, 94315
        • Novartis Investigative Site
      • Stuttgart, Germany, 70191
        • Novartis Investigative Site
      • Villingen-Schwenningen, Germany, 78054
        • Novartis Investigative Site
      • Wallerfing, Germany, 94574
        • Novartis Investigative Site
      • Wangen, Germany, 88239
        • Novartis Investigative Site
      • Wedemark, Germany, 30900
        • Novartis Investigative Site
      • Weiskirchen, Germany, 66709
        • Novartis Investigative Site
      • Wetzlar-Naunheim, Germany, 35584
        • Novartis Investigative Site
      • Wurzen, Germany, 04808
        • Novartis Investigative Site
      • Würzburg, Germany, 97072
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of type 2 diabetes mellitus.
  • Contraindicated or intolerant to take metformin.
  • HbA1c of ≥ 7.0% and ≤ 8.5%
  • Current sulfonylurea (glimepiride) monotherapy and judged by the investigator to be inadequately controlled
  • Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

  • Patients who are taking any other anti-diabetes drug (oral or injection) other than an SU component in the preceding 12 weeks.
  • Acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state within the past 6 month
  • Patients taking sulfonylurea for longer than 5 years
  • History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
  • pregnancy
  • Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vildagliptin
Patients randomized to the vildagliptin group will receive 50mg vildagliptin once daily add-on to their current glimepiride monotherapy for 24 weeks. No dose titrations are permitted during the study.
Drug: LAF237
Vildagliptin will be used as commercially available tablets of 50mg.
Active Comparator: Protaphane
Patients randomized to the Protaphane group will receive a individualized dose of Protaphane once daily as bedtime dose. The Protaphane dose will be titrated within the first 4 weeks to reach fasting plasma glucose values below 100 mg/dl.
Drug: Protaphane
Protaphane will be used as commercially available injection pens

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of patients reaching HbA1c below 7.0% without confirmed hypoglycemia and weight gain
Time Frame: 24 weeks
Primary endpoint is proportion of patients reaching the combined endpoint, defined as a blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events (BG measurement < 3.9mM (71mg/dL)) and weight gain.
24 weeks
Rate of confirmed hypoglycemic events
Time Frame: 24 weeks
Co-primary endpoint is to evaluate the rate of confirmed hypoglycemic events (BG measurement < 3.9mM (71mg/dL)) in type 2 diabetes patients treated with vildagliptin versus NPH insulin add-on to glimepiride.
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of severe hypoglycemic events
Time Frame: 24 weeks
To evaluate the incidence of severe hypoglycemic events (suspected grade 2 and confirmed grade 2 events) in patients treated with vildagliptin versus NPH insulin add-on to glimepiride.
24 weeks
Incidence of symptomatic hypoglycemic events
Time Frame: 24 weeks
To evaluate the incidence of symptomatic hypoglycemic events in patients treated with vildagliptin versus NPH insulin add-on to glimepiride.
24 weeks
Percentage of patients who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic event
Time Frame: 24 weeks
To evaluate the percentage of patients treated with vildagliptin versus NPH insulin add-on to glimepiride who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic events.
24 weeks
Change from baseline in body weight at 24 weeks
Time Frame: Baseline, 24 week
To evaluate body weight changes between study begin and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride.
Baseline, 24 week
Change from baseline in HbA1c at 24 weeks
Time Frame: Baseline, 24 week
To evaluate changes in HbA1c between study begin and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride.
Baseline, 24 week
Change from baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) at 24 week
Time Frame: Baseline, 24 week
The TSQM-9 is a psychometrically sound and valid measure of the major dimensions of patients' satisfaction with medication.
Baseline, 24 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLAF237ADE08
  • 2012-001143-46 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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