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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001143-46 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin | Experimental | 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. |
|
| Protaphane | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAF237 | Drug | Vildagliptin will be used as commercially available tablets of 50mg. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Incidence of symptomatic hypoglycemic events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Anderbeck | 38836 | Germany | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25867771 | Result | 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. | |
| 22295178 | Result | 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. |
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| Protaphane |
| Drug |
Protaphane will be used as commercially available injection pens |
|
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 | 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 | 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 | 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 | The TSQM-9 is a psychometrically sound and valid measure of the major dimensions of patients' satisfaction with medication. | Baseline, 24 week |
| Augsburg |
| 86150 |
| Germany |
| Novartis Investigative Site | Bad Kreuznach | 55545 | Germany |
| Novartis Investigative Site | Bad Oeynhausen | 32549 | Germany |
| Novartis Investigative Site | Balingen | 72336 | Germany |
| Novartis Investigative Site | Berlin | 10115 | Germany |
| Novartis Investigative Site | Berlin | 10117 | Germany |
| Novartis Investigative Site | Berlin | 10627 | Germany |
| Novartis Investigative Site | Berlin | 12347 | Germany |
| Novartis Investigative Site | Berlin | 13189 | Germany |
| Novartis Investigative Site | Berlin | 13597 | Germany |
| Novartis Investigative Site | Cologne | 51069 | Germany |
| Novartis Investigative Site | Dortmund | 44137 | Germany |
| Novartis Investigative Site | Dresden | 01099 | Germany |
| Novartis Investigative Site | Dresden | 01309 | Germany |
| Novartis Investigative Site | Einbeck | 37574 | Germany |
| Novartis Investigative Site | Eisleben Lutherstadt | 06295 | Germany |
| Novartis Investigative Site | Elsterwerda | 04910 | Germany |
| Novartis Investigative Site | Essen | 45219 | Germany |
| Novartis Investigative Site | Essen | 45276 | Germany |
| Novartis Investigative Site | Fulda | 36037 | Germany |
| Novartis Investigative Site | Gelnhausen | 63571 | Germany |
| Novartis Investigative Site | Graben-Neudorf | 76676 | Germany |
| Novartis Investigative Site | Grossheirath-Rossach | 96269 | Germany |
| Novartis Investigative Site | Herne | 44653 | Germany |
| Novartis Investigative Site | Hildesheim | 31139 | Germany |
| Novartis Investigative Site | Kassel | 34125 | Germany |
| Novartis Investigative Site | Kassel | 34127 | Germany |
| Novartis Investigative Site | Kleve | 47533 | Germany |
| Novartis Investigative Site | Lienen | 49536 | Germany |
| Novartis Investigative Site | Löhne | 32584 | Germany |
| Novartis Investigative Site | Magdeburg | 39120 | Germany |
| Novartis Investigative Site | Mainz | 55116 | Germany |
| Novartis Investigative Site | Mayen | 56727 | Germany |
| Novartis Investigative Site | Mülheim | 45468 | Germany |
| Novartis Investigative Site | München | 80339 | Germany |
| Novartis Investigative Site | München | 81373 | Germany |
| Novartis Investigative Site | Oschatz | 04758 | Germany |
| Novartis Investigative Site | Potsdam | 14469 | Germany |
| Novartis Investigative Site | Reinfeld | 23858 | Germany |
| Novartis Investigative Site | Saarlouis | 66740 | Germany |
| Novartis Investigative Site | Saint Ingbert - Oberwuerzbach | 66386 | Germany |
| Novartis Investigative Site | Schliemannstadt Neubukow | 18233 | Germany |
| Novartis Investigative Site | Straubing | 94315 | Germany |
| Novartis Investigative Site | Stuttgart | 70191 | Germany |
| Novartis Investigative Site | Villingen-Schwenningen | 78054 | Germany |
| Novartis Investigative Site | Wallerfing | 94574 | Germany |
| Novartis Investigative Site | Wangen | 88239 | Germany |
| Novartis Investigative Site | Wedemark | 30900 | Germany |
| Novartis Investigative Site | Weiskirchen | 66709 | Germany |
| Novartis Investigative Site | Wetzlar-Naunheim | 35584 | Germany |
| Novartis Investigative Site | Wurzen | 04808 | Germany |
| Novartis Investigative Site | Würzburg | 97072 | Germany |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C475520 | 1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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