Comparison of fasting plasma glucose in patients treated with vildagliptin or sitaglipti

Active, not recruiting

• Conditions: Diabetes mellitus type 2; MedDRA version: 13.1Level: 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: EUCTR2011-000518-21-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-08
• Last Update Posted: 18 September 2012

Recruitment & Eligibility

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

Inclusion Criteria

1.Type 2 diabetic patients stabilized on metformin monotherapy (stable dose for at least 4 weeks prior to Screening) = 1000 mg/day and = 2000 mg/day.
2.Patients must be diagnosed with type 2 diabetes mellitus at least 3 months prior to screening.
3.HbA1c 7.0 – 9.5% (metformin = 1000 mg/day and < 2000 mg/day) or
HbA1c 6.5 – 9.5% (metformin 2000 mg/day) at screening.
4.FPG 126 – 270 mg/dl (7.0 – 15.0 mmol/L) at screening and at randomization.
5.Male and female patients, age 18 to 85 years of age inclusive.

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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.FPG = 270mg/dL (15mmol/L) at Visit 1 and Visit 102.
2.Use of any of the following medications as assessed at Visit 1:
a.use of any antidiabetic medication within the last 12 weeks, except metformin
b.use of weight control products including weight-loss medications in the last 12 weeks.
c.use of oral (=7 consecutive days) or chronic parenteral or intra-articular corticosteroid treatment within the last 8 weeks. Inhaled or topical steroids without systemic effects will be allowed.
d.treatment with growth hormone within the previous 6 months.
e.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.
3.a history or evidence of any of the following at Visit 1:
a.acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state (including precoma and 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.other acute or chronic disease which may cause tissue hypoxic (e.g. respiratory insufficiency, shock) within the past 6 months.
e.coronary artery bypass surgery or percutaneous coronary intervention within the past 6 months.
f.Stroke, transient ischemic attack, or reversible ischemic neurologic deficit within the past 6 months.
g.unstable angina within the past 3 months.
h.sustained and clinically relevant ventricular arrhythmia (patients with premature ventricular contractions if deemed not clinically significant may be enrolled).
i.active substance abuse, alcohol abuse and history of alcohol-related diseases within the past 2 years.
j.type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
k.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.
l.hepatic disorder
m.acute infections which may affect blood glucose control within the past 4 weeks.
n.Acute conditions with the potential to alter renal function within the past 6 months, such as:
•dehydration,
•severe infection,
•shock,
•intravascular administration of iodinated contrast agents
4.any of the following significant laboratory abnormalities as assessed at Visit 1:
a.clinically significant increase or reduction in thyroid stimulating hormone (TSH) outside of the normal range.
b.clinically significant renal dysfunction: glomerular filtration rate (GFR) <60mL/min/1.73m2 (via MDRD formula).
c.alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) at Visit 1, confirmed by repeated measurements within 3 working days.
d.total bilirubin > 2 x ULN and/or direct bilirubin > 1 x ULN confirmed by repeated measurements within 3 working days.
e.positive Hepatitis B surface antigen (HBsAg).
f.positive Hepatitis C virus (HCV) antibody test (anti-HCV).
g.elevated fasting triglycerides (TGs) > 500mg/dL (5.65mmol/L), confirmed by a repeated measurements within 3 working days.
h.clinically significant laboratory abnormalities which, in the opinion of the investigator, cause the patient to be considered inappropriate for inclusion in the study.
5.any of the following electrocardiographic abnormalities at Visit 1:
a.second or third degree atrio-v

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 difference in FPG between vildagliptin and sitagliptin after two weeks in patients with type 2 diabetes mellitus pre-treated with metformin.;Secondary Objective: To assess the difference in FPG between vildagliptin and sitagliptin after a missed dose of either drug in patients with type 2 diabetes mellitus on concomitant treatment with metformin.;Primary end point(s): The primary objective of the study is to demonstrate that the FPG after 14 days of treatment with Vildagliptin is superior to the FPG after 14 days of treatment with.;Timepoint(s) of evaluation of this end point: 14 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoint FPG after a missed dose will be analyzed descriptively using graphical methods and tabulations.;Timepoint(s) of evaluation of this end point: 14 days