A multicenter, double-blind, randomized, active controlled study to compare the effect of 52 weeks treatment with vildagliptin 50 mg bid to pioglitazone 30 mg daily as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy

• Conditions: Type II Diabetes

• Registration Number: EUCTR2005-002199-14-AT
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-12
• Last Update Posted: 20 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 588

Inclusion Criteria

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/mL); 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 patient 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.
•Females using hormonal contraceptives must use a non-hormonal medically approved birth control method in addition during the full course of the study.
2.Patients who have received metformin for at least three months and have been on stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1.
3.Agreement to maintain the same dose of metformin throughout the study.
4.Age in the range of 18 to 77 years inclusive.
5.Body mass index (BMI) in the range of 22-45 kg/m2 inclusive at visit 1.
6.HbA1c in the range of 7.5 to 11% inclusive at visit 1.
7.FPG < 270 mg/dL ( <15 mmol/L) at visit 1.
8.Agreement to maintain prior diet and exercise habits during the full course of the study.
9.Written informed consent to participate in the study.
10.Ability to comply with all study requirements.

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

Exclusion Criteria

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 or gastroparesis.
4.Acute infections which may affect blood glucose control within 4 weeks prior to visit 1.
5.A history of:
•Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation.
•percutaneous coronary intervention within the past 3 months.
•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; unstable angina; or stroke.
6.Congestive heart failure (NYHA class I-IV).
7.Any of the following ECG abnormalities:
•second degree AV block (Mobitz 1 and 2)
•third degree AV block
•prolonged QTc interval (> 500 ms)
8.Malignancy including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years.
9.Liver disease such as cirrhosis or chronic active hepatitis.
10.Significant renal dysfunction (see also exclusion criteria 23 laboratory abnormalities).
11.Acromegaly or treatment with growth hormone or similar drugs.
12.Concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
13.Donation of one unit (500 mL) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
14.Contraindications and warnings according to the country specific label for metformin or pioglitazone not listed in the other exclusion criteria.
15.Known sensitivity to pioglitazone, rosiglitazone or similar drugs.
16.Treatment with any oral anti-diabetic drug other than metformin within 3 months prior to visit 1.
17.Chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months.
18.Chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
19.Treatment with class Ia, Ib and Ic or III anti-arrhythmics.
20.Thyroid hormone replacement is allowed if the dosage has been stable for at least 3 months and the TSH is within normal range at visit 1.
21.Use of other investigational drugs at visit 1, or within 30 days or 5 half-lives of visit 1, whichever is longer, unless local health authority guidelines mandate a longer period.
22.Treatment with any drug with a known and frequent toxicity to a major organ system within the past 3 months (e.g.. cytostatic drugs).
23.Any of the following significant laboratory abnormalities:
•ALT, AST greater than 2.5 times the upper limit of the normal range at visit 1.
•Direct bilirubin greater than 1.3 times the upper limit of the normal range at visit 1.
•Serum creatinine levels = 132 µmol/L (=1.5 mg/dL) males, = 123 µmol/L (=1.4 mg/dL) females.
•TSH outside of normal range at visit 1.
•Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1.
•Fasting

Study & Design

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