Clinical trial NCT01649466: Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Type 2 Diabetes Mellitus Patients.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus, diabetes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-07-25
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percentage of patients reaching HbA1c below 7.0% without confirmed hypoglycemia and weight gain
timeFrame: 24 weeks
measure: Rate of confirmed hypoglycemic events
timeFrame: 24 weeks
Secondary outcomes:
measure: Incidence of severe hypoglycemic events
timeFrame: 24 weeks
measure: Incidence of symptomatic hypoglycemic events
timeFrame: 24 weeks
measure: Percentage of patients who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic event
timeFrame: 24 weeks
measure: Change from baseline in body weight at 24 weeks
timeFrame: Baseline, 24 week
measure: Change from baseline in HbA1c at 24 weeks
timeFrame: Baseline, 24 week
measure: Change from baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) at 24 week
timeFrame: Baseline, 24 week
Other outcomes:
Locations:
city: Anderbeck
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Bad Kreuznach
country: Germany
facility: Novartis Investigative Site
city: Bad Oeynhausen
country: Germany
facility: Novartis Investigative Site
city: Balingen
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Einbeck
country: Germany
facility: Novartis Investigative Site
city: Elsterwerda
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Fulda
country: Germany
facility: Novartis Investigative Site
city: Gelnhausen
country: Germany
facility: Novartis Investigative Site
city: Graben-Neudorf
country: Germany
facility: Novartis Investigative Site
city: Grossheirath-Rossach
country: Germany
facility: Novartis Investigative Site
city: Herne
country: Germany
facility: Novartis Investigative Site
city: Hildesheim
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Kleve
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Lienen
country: Germany
facility: Novartis Investigative Site
city: Loehne
country: Germany
facility: Novartis Investigative Site
city: Lutherstadt Eisleben
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Mayen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Mülheim
country: Germany
facility: Novartis Investigative Site
city: Neubukow
country: Germany
facility: Novartis Investigative Site
city: Oschatz
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Reinfeld
country: Germany
facility: Novartis Investigative Site
city: Saarlouis
country: Germany
facility: Novartis Investigative Site
city: St. Ingbert - Oberwuerzbach
country: Germany
facility: Novartis Investigative Site
city: Straubing
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Villingen-Schwenningen
country: Germany
facility: Novartis Investigative Site
city: Wallerfing
country: Germany
facility: Novartis Investigative Site
city: Wangen
country: Germany
facility: Novartis Investigative Site
city: Wedemark
country: Germany
facility: Novartis Investigative Site
city: Weiskirchen
country: Germany
facility: Novartis Investigative Site
city: Wetzlar-Naunheim
country: Germany
facility: Novartis Investigative Site
city: Wurzen
country: Germany
facility: Novartis Investigative Site
city: Würzburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Forst T, Koch C, Dworak M. Vildagliptin versus insulin in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea: results from a randomized, 24 week study. Curr Med Res Opin. 2015 Jun;31(6):1079-84. doi: 10.1185/03007995.2015.1039936. Epub 2015 May 20.
citation: Zuckermann A, Wang SS, Ross H, Frigerio M, Eisen HJ, Bara C, Hoefer D, Cotrufo M, Dong G, Junge G, Keogh AM. Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial. J Transplant. 2011;2011:535983. doi: 10.1155/2011/535983. Epub 2011 Sep 13.