A Phase IIa, Double-Blind, Placebo-Controlled, Randomised, Fourfold Cross-Over Study to Investigate the Glucose Lowering Effects of Dextromethorphan and Amantadine in Subjects with Type 2 Diabetes Mellitus (T2DM) after an Oral Glucose Tolerance Test

• Conditions: Type 2 diabetes mellitus; MedDRA version: 14.0Level: 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: EUCTR2011-002986-39-DE
• Lead Sponsor: Profil Institut für Stoffwechselforschung GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-22
• Last Update Posted: 24 June 2013

Recruitment & Eligibility

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

Inclusion Criteria

Male with T2DM on a stable regimen of metformin monotherapy, between 45 and 70 years of age, with a BMI between 25 and 35 kg/m2, HbA1c between 6.5 and 8% (extremes included).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4
;
Male with T2DM on a stable regimen of metformin monotherapy, between 45 and 70 years of age, with a BMI between 25 and 35 kg/m2, HbA1c between 6.5 and 8% (extremes included).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

- Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis
- Current or previous treatment with insulin therapy
- Treatment with any hypoglycaemic medication other than metformin within the three months prior to screening
- Any severe medical or surgical history of conditions likely to confound study assessments or study endpoints
- Serious respiratory, serious and/or unstable coronary heart disease, congestive heart failure of New York Heart Association Class II or worse, second/third degree heart block, superior vena cava syndrome, uncontrolled hypertension, history of stroke (within the preceding 6 months) or serious peripheral vascular disease
- History of arrhythmia that is symptomatic or requires treatment
- Marked diabetic complications
- Any respiratory disease leading to respiratory insufficiency and/or depression
- Clinically significant vital signs or 12-lead ECG findings
- Clinical or laboratory evidence of hepatic dysfunction or disease
- Moderate or severe renal dysfunction defined as a calculated GFR <70 ml/min
- Uncontrolled high blood pressure
- History of relevant drug and/or food allergies or a history of severe anaphylactic reaction
- Use of concomitant medication which would confound study conduct
;
- Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis
- Current or previous treatment with insulin therapy
- Treatment with any hypoglycaemic medication other than metformin within the three months prior to screening
- Any severe medical or surgical history of conditions likely to confound study assessments or study endpoints
- Serious respiratory, serious and/or unstable coronary heart disease, congestive heart failure of New York Heart Association Class II or worse, second/third degree heart block, superior vena cava syndrome, uncontrolled hypertension, history of stroke (within the preceding 6 months) or serious peripheral vascular disease
- History of arrhythmia that is symptomatic or requires treatment
- Marked diabetic complications
- Any respiratory disease leading to respiratory insufficiency and/or depression
- Clinically significant vital signs or 12-lead ECG findings
- Clinical or laboratory evidence of hepatic dysfunction or disease
- Moderate or severe renal dysfunction defined as a calculated GFR <70 ml/min
- Uncontrolled high blood pressure
- History of relevant drug and/or food allergies or a history of severe anaphylactic reaction
- Use of concomitant medication which would confound study conduct

Study & Design

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