A multicenter, double-blind, randomized parallel-group study to demonstrate the effect of 24 weeks treatment with vildagliptin 100 mg qd as add-on to metformin 500 mg bid compared to metformin up to 1000 mg bid in patients with type 2 diabetes inadequately controlled on metformin 500 mg bid monotherapy.

ovartis Pharma Services AG0 sites860 target enrollmentOctober 12, 2006

DrugsMetformine 500 mg

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: ovartis Pharma Services AG
Enrollment: 860
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 12, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Pharma Services AG

Eligibility Criteria

Inclusion Criteria

•Inclusion criteria (assessed during screening):
•1\.Male, non\-fertile female or female of childbearing potential using a medically approved birth control method.
•A non\-fertile female is defined as: post menopausal (12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \>40 mIU/m); 6 weeks post bilateral oophorectomy with or without hysterectomy; post hysterectomy; or sterilized by tubal ligation.
•A female of childbearing potential is defined as any woman physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means.
•Medically approved birth control method include: hormonal contraceptives, IUD, and double\-barrier contraception. Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post\-ovulation methods) and withdrawal are not acceptable methods of contraception.
•Reliable contraception should be maintained throughout the study.
•2\.Age in the range of 18\-78 years inclusive.
•3\.Patients with T2DM who have taken 850\-1000 mg daily dose of metformin monotherapy for at least 2 months immediately prior to visit 1\.
•4\.Diagnosis of T2DM for at least 2 months prior to study entry (visit 1\).
•5\.Body mass index (BMI) in the range of 22\-45 kg/m2 inclusive at visit 1\.

Exclusion Criteria

•Exclusion criteria (assessed during screening):
•1\.Pregnant or lactating female.
•2\.A history of:
•type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing’s syndrome and acromegaly.
•acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
•3\.Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy, gastroparesis, as well as symptoms of worsening hyperglycemia (i.e. polyuria, polydipsia, weight loss) in the absence of any intercurrent illness or other incidental circumstances potentially causing deterioration of glucose control.
•4\.Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
•5\.Any of the following within the past 6 months:
•myocardial infarction (MI) (if the visit 1 ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the patient can enter the study at the discretion of the investigator and the sponsor);
•coronary artery bypass surgery or percutaneous coronary intervention;