A 24-week, multi-center, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of vildagliptin 50mg bid as an add-on therapy to insulin, with or without metformin, in patients with type 2 diabetes mellitus
- Conditions
- Type II Diabetes Mellitus
- Registration Number
- EUCTR2010-020684-20-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 428
1.Confirmed diagnosis of T2DM by standard criteria.
2.Treatment with stable, once or twice daily doses (maximum dose of 1 unit/kg/day) of basal long-acting, intermediate-acting insulin alone or in pre-mixed combination with rapid-acting or short-acting insulin for at least 12 weeks prior to Visit 1. Stable is defined as ±10% of the Visit 1 dose during the previous 12 weeks.
3.Patients receiving metformin must be on a stable dose of metformin (at least 1500 mg daily or a maximally tolerated dose) for at least 12 weeks prior to Visit 1.
4.HbA1c =7.5 to =11% at Visit 1
5.Age: =18 to =80 years old at Visit 1
6.BMI =22 to =40 kg/m2 at Visit 1.
7.Males or females
8.Females must be non-fertile or females of childbearing potential must use a medically approved birth control method based on local regulations
9.Agreement to maintain a stable dose of insulin and metformin, if applicable, throughout the study.
10.Agreement to continue current diet and exercise regime throughout the duration of the study, unless otherwise instructed by the investigator.
11.Ability to comply with all study requirements.
12.Written informed consent must be obtained before any assessment is performed
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.FPG =270 mg/dl (15 mmol/L) at Visit 1
2.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
3.Use of any of the following medications as assessed at Visit 1:
a.rapid or short acting insulin except in pre-mixed formulations with intermediate or long-acting insulin; insulin administration more frequently than twice-daily, or total insulin dose >1 unit/kg/day for the past 12 weeks
b.Use of weight control products including weight-loss medications
c.DPP-4 inhibitors, GLP-1 analogues/mimetics, Oral Anti-diabetic Agents (OADs) except metformin within the previous 6 months
d.Chronic oral (>7 consecutive days), parenteral or intra-articular corticosteroid treatment within 8 weeks
e.Treatment with growth hormone within the previous 6 months
f.Treatment with any drug of known and frequent toxicity to a major organ, or that may interfere with the interpretation of the efficacy and safety data during the study.
4.A history or evidence of any of the following:
a.Acute metabolic conditions such an ketoacidosis, lactic acidosis or hyperosmolar state (including coma) within the past 6 months.
b.Current diagnosis of congestive heart failure (NYHA III or IV).
c.Myocardial infarction (MI) within the past 6 months
d.Coronary artery bypass surgery or percutaneous coronary intervention within the past 6 months
e.Stroke or transient ischemic attack (TIA) within the past 6 months
f.Unstable angina within the past 3 months
g.Sustained and clinically relevant ventricular arrhythmia
h.Active substance abuse including alcohol (> 3 drinks per day on average and/or binge drinking of more than 5 drinks in 1 day during the last 6 months) and alcohol related history of disease 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:
i.acute or chronic liver disease, evidence of hepatitis, cirrhosis or portal hypertension
ii.history of imaging abnormalities that suggest liver disease (except hepatic steatosis), such as portal hypertension, capsule scalloping, cirrhosis
l.acute infections which may affect blood glucose conrtol within the past 4 weeks
5.Any of the following significant laboratory abnormalities as assessed at Visit 1:
a.Clinically significant TSH outside of the normal range
b.Clinically significant renal dysfunction as indicated by serum creatinine levels at Visit 1:
i.for patients receving metformin = 1.5 mg/dL (132 µmol/L) for males and = 1.4 mg/dL (123 µmol/L) for females;
ii.for other patients: abnormal creatinine clearance or evidence of renal impairment as determined by eGFR <30 ml/min/1.73m2 (MDRD)
c.Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) at Visit 1, confirmed by repeat measure within 3 working days
d.Total bilirubin > 2 xULN and/or direct bilirubin > 1 x ULN confirmed by repeat measure within 3 working days
e.Positive Hepatitis B surface antigen (HbsAg)
f.Positive Hepatitis C antibody test (anti-HCV)
g.Elevat
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of vildagliptin 50 mg bid add-on therapy, as compared to placebo, to reduce HbA1c after 24 weeks treatment in patients with T2DM treated with stable doses of basal long-acting, intermediate-acting or pre-mixed insulin, with or without concomitant metformin therapy.;Secondary Objective: •To assess the efficacy of vildagliptin 50 mg bid add-on therapy, as compared to placebo, to reduce HbA1c after 24 weeks of treatment in the subpopulation of patients with T2DM treated with insulin and metformin.<br>•To assess the efficacy of vildagliptin 50 mg bid add-on therapy, as compared to placebo, to reduce HbA1c after 24 weeks of treatment in the subpopulation of patients with T2DM treated with insulin without metformin.<br>;Primary end point(s): Change from baseline in HbA1c
- Secondary Outcome Measures
Name Time Method