Multicenter, double-blind, randomized, placebo controlled, dose ranging phase 2 study to investigate efficacy, safety, tolerability and pharmacokinetics of the DPP-IV inhibitor RO0730699 in patients with type 2 diabetes, who are treated with a stable dose of metformi

• Conditions: Type 2 diabetes; MedDRA version: 7Level: lowClassification code 10012613

• Registration Number: EUCTR2004-004529-84-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

- Type 2 diabetes treated with the maximum tolerated dose of metformin (minimum 1500 mg daily dose, maximum not higher than recommended in the label) for at least 3 months before screening
- HbA1c > or equal 7.0% and < or equal 10.0% at screening
- FPG at screening
> 126 mg/dL (7.0 mmol/L) and
< or equal 240 mg/dL (13.3 mmol/L)
- BMI < or equal 40 kg/m2
- Age 18 to 75 years
- Able and willing to give written informed consent and to comply with the requirements of the study

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

-Type 1 diabetes
- History of ketoacidosis or lactic acidosis
- Any anti-hyperglycemic medication other than metformin during the last 3 months (combination therapy)
- Use of systemic corticosteroids during the last 3 months
- History of convulsions and/or epilepsy
- Central nervous system disease with potential impact on the blood brain barrier, ie. history of stroke, Alzheimer’s disease, cerebrovascular dementia.
- Impaired liver function (ALAT, ASAT, total bilirubin or alkaline phosphatase >2.5 x ULN) at screening
- Contraindications to metformin, i.e.
* Impaired renal function (serum creatinine > 1.5 mg/dL [ > 133 micromol/L] in males and >1.3 mg/dL [>115micromol/L] in females)
* Congestive heart failure requiring pharmacologic treatment
* Respiratory insufficiency
- Myocardial infarction < 6 months before screening
- Uncontrolled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg despite treatment)
- Known proliferative diabetic retinopathy
- Serious illness, such as active cancer, major active infection, severe psychiatric disorders
- Pregnant or lactating women or women with childbearing potential not using adequate method of contraception
- Participation in a clinical trial with an investigational drug within 3 months prior to the screening examination

Study & Design

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