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

Type 2 Diabetes Mellitus Clinical Trial

— BENEFIT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01649466
• Other study ID #: CLAF237ADE08
• Secondary ID: 2012-001143-46
• Status: Completed
• Phase: Phase 4
• First received: July 20, 2012
• Last updated: November 16, 2016
• Start date: August 2012
• Est. completion date: October 2013

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• LAF237
Vildagliptin will be used as commercially available tablets of 50mg.
• Protaphane
Protaphane will be used as commercially available injection pens

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Anderbeck
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Bad Kreuznach
Germany	Novartis Investigative Site	Bad Oeynhausen
Germany	Novartis Investigative Site	Balingen
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Einbeck
Germany	Novartis Investigative Site	Elsterwerda
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Fulda
Germany	Novartis Investigative Site	Gelnhausen
Germany	Novartis Investigative Site	Graben-Neudorf
Germany	Novartis Investigative Site	Grossheirath-Rossach
Germany	Novartis Investigative Site	Herne
Germany	Novartis Investigative Site	Hildesheim
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Kleve
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Lienen
Germany	Novartis Investigative Site	Loehne
Germany	Novartis Investigative Site	Lutherstadt Eisleben
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Mayen
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Mülheim
Germany	Novartis Investigative Site	Neubukow
Germany	Novartis Investigative Site	Oschatz
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Reinfeld
Germany	Novartis Investigative Site	Saarlouis
Germany	Novartis Investigative Site	St. Ingbert - Oberwuerzbach
Germany	Novartis Investigative Site	Straubing
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Villingen-Schwenningen
Germany	Novartis Investigative Site	Wallerfing
Germany	Novartis Investigative Site	Wangen
Germany	Novartis Investigative Site	Wedemark
Germany	Novartis Investigative Site	Weiskirchen
Germany	Novartis Investigative Site	Wetzlar-Naunheim
Germany	Novartis Investigative Site	Würzburg
Germany	Novartis Investigative Site	Wurzen

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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: 10.1185/03007995.2015.103 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients reaching HbA1c below 7.0% without confirmed hypoglycemia and weight gain	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	No
Primary	Rate of confirmed hypoglycemic events	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	Yes
Secondary	Incidence of severe hypoglycemic events	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	Yes
Secondary	Incidence of symptomatic hypoglycemic events	To evaluate the incidence of symptomatic hypoglycemic events in patients treated with vildagliptin versus NPH insulin add-on to glimepiride.	24 weeks	Yes
Secondary	Percentage of patients who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic event	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	No
Secondary	Change from baseline in body weight at 24 weeks	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	No
Secondary	Change from baseline in HbA1c at 24 weeks	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	No
Secondary	Change from baseline in Treatment Satisfaction Questionnaire for Medication (TSQM-9) at 24 week	The TSQM-9 is a psychometrically sound and valid measure of the major dimensions of patients' satisfaction with medication.	Baseline, 24 week	No

External Links

•   Results for CLAF237ADE08 from the Novartis Clinical Trials Website