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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01649466
First received: July 20, 2012
Last updated: June 10, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: LAF237
Drug: Protaphane
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of patients reaching HbA1c below 7.0% without confirmed hypoglycemia and weight gain [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Rate of confirmed hypoglycemic events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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 vildagliptinversus NPH insulin add-on to glimepiride.


Secondary Outcome Measures:
  • Incidence of severe hypoglycemic events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    To evaluatethe 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.

  • Incidence of symptomatic hypoglycemic events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    To evaluate the incidence of symptomatic hypoglycemic events in patients treated with vildagliptin versus NPH insulin add-on to glimepiride.

  • Percentage of patients who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic event [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    To evaluate thepercentage 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.

  • Change from baseline in body weight at 24 weeks [ Time Frame: Baseline, 24 week ] [ Designated as safety issue: No ]
    To evaluate body weight changes between study begin and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride.

  • Change from baseline in HbA1c at 24 weeks [ Time Frame: Baseline, 24 week ] [ Designated as safety issue: No ]
    To evaluate changes in HbA1c between study begin and study end in patients treated with vildagliptin versus NPH insulin add-on to glimepiride.

  • Change from baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) at 24 week [ Time Frame: Baseline, 24 week ] [ Designated as safety issue: No ]
    The TSQM-9 is a psychometrically sound and valid measure of the major dimensions of patients' satisfaction with medication.


Enrollment: 162
Study Start Date: August 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 individulazed 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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649466

  Show 53 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01649466     History of Changes
Other Study ID Numbers: CLAF237ADE08, 2012-001143-46
Study First Received: July 20, 2012
Last Updated: June 10, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Novartis:
Type 2 diabetes mellitus, diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Vildagliptin
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013