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

NCT01649466 | Completed Phase 4

• 2 other identifiers: CLAF237ADE082012-001143-46
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 53

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus, diabetes

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Incidence of severe hypoglycemic events

  24 weeks

• Incidence of symptomatic hypoglycemic events

  24 weeks

• Percentage of patients who reach their blood glucose target (HbA1c below 7.0%) without any confirmed hypoglycemic event

  24 weeks

• Change from baseline in body weight at 24 weeks

  Baseline, 24 week

• Change from baseline in HbA1c at 24 weeks

  Baseline, 24 week

Study Arms (2)

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.

Drug: LAF237

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.

Drug: Protaphane

Interventions

LAF237 DRUG

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

Vildagliptin

Protaphane DRUG

Protaphane will be used as commercially available injection pens

Protaphane

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (53)

Novartis Investigative Site

Anderbeck, 38836, Germany

Location

Novartis Investigative Site

Augsburg, 86150, Germany

Location

Novartis Investigative Site

Bad Kreuznach, 55545, Germany

Location

Novartis Investigative Site

Bad Oeynhausen, 32549, Germany

Location

Novartis Investigative Site

Balingen, 72336, Germany

Location

Novartis Investigative Site

Berlin, 10115, Germany

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Berlin, 10627, Germany

Location

Novartis Investigative Site

Berlin, 12347, Germany

Location

Novartis Investigative Site

Berlin, 13189, Germany

Location

Novartis Investigative Site

Berlin, 13597, Germany

Location

Novartis Investigative Site

Cologne, 51069, Germany

Location

Novartis Investigative Site

Dortmund, 44137, Germany

Location

Novartis Investigative Site

Dresden, 01099, Germany

Location

Novartis Investigative Site

Dresden, 01309, Germany

Location

Novartis Investigative Site

Einbeck, 37574, Germany

Location

Novartis Investigative Site

Eisleben Lutherstadt, 06295, Germany

Location

Novartis Investigative Site

Elsterwerda, 04910, Germany

Location

Novartis Investigative Site

Essen, 45219, Germany

Location

Novartis Investigative Site

Essen, 45276, Germany

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Novartis Investigative Site

Fulda, 36037, Germany

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Novartis Investigative Site

Gelnhausen, 63571, Germany

Location

Novartis Investigative Site

Graben-Neudorf, 76676, Germany

Location

Novartis Investigative Site

Grossheirath-Rossach, 96269, Germany

Location

Novartis Investigative Site

Herne, 44653, Germany

Location

Novartis Investigative Site

Hildesheim, 31139, Germany

Location

Novartis Investigative Site

Kassel, 34125, Germany

Location

Novartis Investigative Site

Kassel, 34127, Germany

Location

Novartis Investigative Site

Kleve, 47533, Germany

Location

Novartis Investigative Site

Lienen, 49536, Germany

Location

Novartis Investigative Site

Löhne, 32584, Germany

Location

Novartis Investigative Site

Magdeburg, 39120, Germany

Location

Novartis Investigative Site

Mainz, 55116, Germany

Location

Novartis Investigative Site

Mayen, 56727, Germany

Location

Novartis Investigative Site

Mülheim, 45468, Germany

Location

Novartis Investigative Site

München, 80339, Germany

Location

Novartis Investigative Site

München, 81373, Germany

Location

Novartis Investigative Site

Oschatz, 04758, Germany

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Novartis Investigative Site

Potsdam, 14469, Germany

Location

Novartis Investigative Site

Reinfeld, 23858, Germany

Location

Novartis Investigative Site

Saarlouis, 66740, Germany

Location

Novartis Investigative Site

Saint Ingbert - Oberwuerzbach, 66386, Germany

Location

Novartis Investigative Site

Schliemannstadt Neubukow, 18233, Germany

Location

Novartis Investigative Site

Straubing, 94315, Germany

Location

Novartis Investigative Site

Stuttgart, 70191, Germany

Location

Novartis Investigative Site

Villingen-Schwenningen, 78054, Germany

Location

Novartis Investigative Site

Wallerfing, 94574, Germany

Location

Novartis Investigative Site

Wangen, 88239, Germany

Location

Novartis Investigative Site

Wedemark, 30900, Germany

Location

Novartis Investigative Site

Weiskirchen, 66709, Germany

Location

Novartis Investigative Site

Wetzlar-Naunheim, 35584, Germany

Location

Novartis Investigative Site

Wurzen, 04808, Germany

Location

Novartis Investigative Site

Würzburg, 97072, Germany

Location

Related 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: 10.1185/03007995.2015.1039936. Epub 2015 May 20.

  PMID: 25867771 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.

  PMID: 22295178 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: July 25, 2012
• Study Start: August 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 17, 2016

Record last verified: 2016-11

Locations

DE (53)