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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

August 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

July 24, 2012

First Posted (Estimate)

July 25, 2012

Study Record Updates

Last Update Posted (Estimate)

November 17, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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