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Completed

NCT Number: NCT01649466

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Anderbeck, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LAF237

Drug

Vildagliptin will be used as commercially available tablets of 50mg.

Protaphane

Drug

Protaphane will be used as commercially available injection pens

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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.

Acronym: BENEFIT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 25, 2012
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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