Comparison of safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus

• Conditions: type-2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy; MedDRA version: 15.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-001143-46-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-27
• Last Update Posted: 18 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Age > 18 and < 85 years
2.Written informed consent must be obtained before any assessment is performed.
3.Confirmed diagnosis of T2DM.
4.Contraindicated or intolerant to take metformin.
5.HbA1c of = 7.0% and = 8.5% as determined by a central laboratory at Visit 1 and judged by the investigator to be inadequately controlled that requires the expansion of the current anti diabetic therapy.
6.Patients treated with any SU for at least the prior 12 weeks including a stable dose of glimepiride of 4mg (or if not tolerated, the maximal tolerated dose up to 4mg) for at least 4 weeks prior to Visit 1.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1.Patients who are taking any other anti-diabetes drug (oral or injection) other than an SU component in the preceding 12 weeks.
2.Use of any prohibited medication as per protocol section 6.6.
3.A history or evidence of any of the following:
a.Acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state (including diabetic precoma or coma) within the past 6 months.
b.Current diagnosis of congestive heart failure (NYHA III or IV).
c.Myocardial infarction within the past 6 months.
d.Coronary artery bypass surgery or percutaneous coronary intervention within the past 6 months
e.Stroke, transient ischemic attack, or reversible ischemic neurologic deficit within the past 6 months.
f.Unstable angina within the past 3 months.
g.Sustained and clinically relevant ventricular arrhythmia (patients with premature ventricular contractions if deemed not clinically significant may be enrolled).
h.Active substance abuse, alcohol abuse and history of alcohol-related diseases within the past 2 years.
i.Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g. Cushing’s syndrome or acromegaly-associated diabetes).
j.Malignancy of an organ system (other than localized basal cell carcinoma of the skin) treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
k.hepatic disorder defined as:
• Acute or chronic liver disease, evidence of hepatitis, cirrhosis or portal hypertension.
• History of imaging abnormalities that suggest liver disease (except hepatic steatosis), such as portal hypertension, capsule scalloping, cirrhosis.
l. Evidence of active pancreatitis within the 1 month prior to baseline assessment
4.Any of the following significant laboratory abnormalities as assessed at Visit 1:
a.Clinically significant renal dysfunction: glomerular filtration rate (GFR) <30mL/min/1.73m2 (via modification of diet in renal disease (MDRD) formula).
b.alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3x upper limit of normal (ULN), confirmed by repeat measure within 3 working days.
c.Total bilirubin (except patients with Gilbert`s disease) > 2x ULN, confirmed by repeat measure within 3 working days.
d.Clinically significant laboratory abnormalities which, in the opinion of the investigator, cause the patient to be considered inappropriate for inclusion in the study.
5.Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
6.Patients who do not agree to take the study medication and do not want to follow the procedure as required by the study protocol.
7.Patients taking the SU component for longer than 5 years before Visit 1.
8.BMI < 21 or > 45 kg/m2 at Visit 1.
9.Donation of blood (500ml) or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period.
10.Potentially unreliable, inability to comply with the study procedures or medications, and/or judged by the investigator to be unsuitable for the study.
11.Use of an investigative drug within 30 days or 5 half-lives of the drug, whichever is longer.
12.History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
13.Study personnel or first de

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified