A double-blind, double-dummy, randomized, controlled, multi-centre study of the activity and safety of 2 daily doses of EMD 387008 versus placebo and metformin in parallel groups after 8 weeks of treatment in type 2 diabetic subjects. - DEEP study

• Conditions: Phase II study on type 2 diabetic subjects

• Registration Number: EUCTR2006-002902-74-LV
• Lead Sponsor: Merck Santé s.a.s.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

- Male and female type 2 diabetic subjects who are not receiving antidiabetic treatment or who are being treated with antidiabetic monotherapy including metformin, sulfonylurea, glinide or acarbose·
- Age between 18 and 70 years·
- Body mass index (BMI) >=20 and <40 kg/m²·
- Fasting plasma glucose >=7.8 mmol/L and <=13.3 mmol/L (>=140 mg/dL and <=240 mg/dL) at Visit 4a·
- HbA1c <=10%, at screening visit.
- No treatment with thiazolidinediones or insulin within 3 months before randomization·
- No treatment with statin or fibrate within 3 months before randomization·
- Creatinine clearance equal or above 60 mL/[min*1.73 m2] as estimated by the Modification of Diet in Renal Disease (MDRD) formula·
- Albuminuria of <300 µg/mg creatininuria·
- No acute cardiovascular event within 3 months before randomization·
- Effective contraception for women if the risk for conception exists·
- Subject has given written informed consent before any study-related activities are carried out
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

- Any disease which in the investigator’s opinion would exclude the subject from the study·
- Acute or chronic diseases which can cause severe tissue hypoxia, e.g. cardiac and respiratory insufficiency or acute myocardial infarction·
- Acute conditions which can impair renal function, e.g. dehydration or severe infections·
- Uncontrolled high blood pressure [BP] (diastolic BP >100 mmHg or systolic BP >180 mmHg)·
- History of drug-induced Torsade de Pointes, or presence of a familial long QT syndrome·
- Impairment of hepatic function (alkaline phosphatase or aspartate aminotransferase [AST], or alanine aminotransferase [ALT] >3 x the upper limit of normal)·
- Evidence of retinopathy of severity >=35, in the Classification of Retinopathy Severity (Early Treatment Diabetic Retinopathy Study (assessed by an ophthalmologist in the 6 months preceding inclusion)·
- Pregnancy or lactation·
- History of any clinically important neurological disorders and/or epilepsy·
- Mental handicap, legal incapacity, or any history of clinically important emotional and/or psychiatric illness·
- Presence of a contraindication to the study medication, including metformin·
- Known hypersensitivity to any of the constituents or excipients of the study drug and metformin tablets, or history of relevant drug and/or food allergies (e.g. anaphylactic, anaphylactoid reactions)·
- Change in currently used medication and/or use of any new prescription or non-prescription medication within 14 days prior to randomization. The occasional use of paracetamol is not prohibited·
- Positive screen for hepatitis B surface antigen (HbsAg), antibody to the hepatitis A virus (anti-HAV; immunoglobulin M [IgM]), antibody to hepatitis C virus (anti-HCV) or antibodies to human immunodeficiency virus (anti-HIV) 1 and 2 at screening·
- Any history of alcohol abuse or drug addiction·
- Smoking of more than 10 cigarettes or 3 cigars or 3 pipes per day ·
- Participation in a clinical study within 60 days before randomization ·
- Donation of blood within 90 days before randomization

Study & Design

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