AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 2DXM/AMTNCT01441986

Dextromethorphan, Amantadine and Glucose Homeostasis in Diabetes Subjects

A Phase 2 study testing Dextromethorphan hydrobromide and Amantadine in people with Type 2 Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this trial is to demonstrate that dextromethorphan (DXM) and amantadine compared to placebo exert blood glucose (BG) lowering effects following an oral glucose tolerance test (OGTT) in male subjects with T2DM. Read more about this study

Who is it for?
Ages 45 to 70 years, men only
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Dextromethorphan hydrobromide and Amantadine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteGermany
Study dates
Sep 2011to May 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male subjects with a diagnosis of type 2 diabetes mellitus according to ADA criteria at least 4 months prior to screening
  • Medical history without major pathology (with the exception of type 2 diabetes)
  • On a stable regimen of metformin monotherapy for at least 3 months
  • Body mass index (BMI) between 25 and 35kg/m2, both inclusive
  • HbA1c ≥ 6.5 and <7.5%
  • A male subject who is sexually active and not surgically sterilised, must agree to use adequate contraceptive methods from the time of first study drug administration until 90 days after last dosing.
  • Ability and willingness to abstain from grapefruit juice (and all grapefruit containing products) throughout the study starting 24 hours prior to first study drug administration and from alcohol, methylxanthine-containing beverages or food (coffee, tea, Coke, chocolate, "power drinks"), tobacco products and from engaging in strenuous physical activity from 24 hours prior to each admission until discharge from the unit.

Who cannot join

  • 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 (except for treatment within a clinical trial, for surgical procedures or during an acute illness for 7 days and more than 14 days before the first administration of study drug)
  • Treatment with any hypoglycaemic medication other than metformin within the three months prior to screening
  • Subjects with any severe medical or surgical history of conditions likely to confound study assessments or study endpoints, for example but not limited to haemoglobinopathies, inflammatory bowel disease, cystic fibrosis, bariatric surgery and/or any surgery shortening the intestine, history of galactose intolerance, lactose- or glucose-galactose-malabsorption
  • Serious respiratory, serious and/or unstable coronary heart disease (unstable angina, myocardial infarction within the preceding 6 months), congestive heart failure of New York Heart Association Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnoea), second/third degree heart block, superior vena cava syndrome, uncontrolled hypertension, history of congenital QT-syndrome within family, history of stroke (within the preceding 6 months) or serious peripheral vascular disease
  • History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (grade 3), left bundle branch block, or asymptomatic sustained ventricular tachycardia are not allowed
Show all 26Show fewer
  • Marked diabetic complications: severe autonomic or sensory neuropathy including gastroparesis; proliferative retinopathy
  • Any respiratory disease leading to respiratory insufficiency and/or depression including but not limited to: asthma bronchiale, chronic obstructive pulmonary disease.
  • Clinically significant vital signs including known bradycardia with pulse rate < 55/min or 12-lead ECG findings including pre-treatment QTc > 420 msec (if the ECG shows a QTc value of > 420 ms, two further ECGs will be repeated within the next 30 minutes, at least 2 minutes apart, with the mean value of these 3 consecutive ECGs being conclusive).
  • History of or current prostata hyperplasia
  • History of or current narrow angle glaucoma
  • Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis or coagulation screening tests, as judged by the Investigator
  • Moderate or severe renal dysfunction defined as a calculated GFR < 70 ml/min using the Cockcroft-Gault calculation
  • Clinical or laboratory evidence of hepatic dysfunction or disease; laboratory evidence defined as any of the following parameters: alkaline phosphatase > 2x upper limit of normal (ULN), ALT > 2x ULN, AST > 2x ULN or bilirubin > 3x ULN. Isolated mild rise in bilirubin considered to be due to Gilbert's condition is allowed
  • Uncontrolled high blood pressure (DBP > 95 mmHg and/or SBP > 160 mmHg), unless clearly documented to be white-coat hypertension
  • History of any psychiatric condition that might impair the subject's ability to understand or to comply with the requirements of the study or to provide informed consent
  • History of relevant drug and/or food allergies or a history of severe anaphylactic reaction
  • Smoking more than 5 cigarettes/cigars/pipes daily and not willing to abstain from any consume of tobacco products 24 hours prior to each admission until discharge
  • Currently active or history of alcohol abuse (defined as an intake of more than 24 units of alcohol per week; one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits) or drug addiction (including soft drugs like cannabis products)
  • Positive alcohol test at screening Use of concomitant medication which would confound study conduct
  • Monoamine oxidase (MAO) inhibitors or selective serotonin reuptake inhibitors (SSRI) (Fluoxetine, Paroxetine), any other antipsychotic and antidepressant medication or drugs with depressant effects on the central nervous system.
  • Antiarrhythmic therapy class IA (e.g. Chinidin, Disopyramide, Procainamide) and class III (e.g. Sotalol)
  • Antihistaminic therapy (e.g. Astemizole, Terfenadine)
  • Use of macrolide antibiotics (e.g. Erythromycin, Clarythromycin) and gyrase inhibitors (e.g. Sparfloxacin) Use of antimycotic therapy (e.g. Bupidin, Halofantrine, Cotrimoxazole, Pentamidine, Cisapride, Bepridil)
  • Use of weight-loss agents
  • Medications which have the potential to inhibit CYP450 2D6: Amiodarone, Chinidin, Haloperidol, Paroxetine, Propafenone, Thioridazine, Cimetidine and Ritonavir.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil Institute for Metabolic Research

    Neuss, North Rhine-Westphalia, 41460

Other trials in Germany

About this study

Official title: A Phase IIa, Double-blind, Placebo-controlled, Randomised, Fourfold Crossover 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

The purpose of this trial is to demonstrate that dextromethorphan (DXM) and amantadine compared to placebo exert blood glucose (BG) lowering effects following an oral glucose tolerance test (OGTT) in male subjects with T2DM.

Read the detailed description

Type 2 diabetes mellitus (T2DM) is characterized by hyperglycemia due to an impaired insulin activity (insulin resistance) or a reduced insulin production by the pancreas. The restoration of adequate insulin secretion represents one of the goals of several antidiabetic therapies such as sulfonylureas or incretin mimetics. Lowering blood glucose in type 2 diabetes mellitus (T2DM) prevents complications, microvascular complications in particular. Weight reduction is also a fundamental target in the treatment of T2DM; however, achieving weight loss through lifestyle measures is difficult, and the problem of obesity is often exacerbated by therapy with glucose-lowering agents such as insulin, that cause weight gain.

Pancreatic ß- cells are part of the pancreatic islets, of which 1-2 millions are located within the human pancreas. Interestingly, pancreas function is controlled in part by the central nervous system and ß- cells have many features in common with neurons, including the expression of tyrosine hydroxylase (TH), neural guidance molecules, such as Eph receptors and ephrins, neural cell adhesion molecules, such as N-Cadherin and NCAM (Neural Cell Adhesion Molecule), and NMDA (N-Methyl-D-Aspartate)-type glutamate receptors. Thus, it has been hypothesized that some drugs available for manipulating the central nervous system(CNS) may also act on the pancreatic ß- cells and may be of use for T2DM and MODY treatment. NMDA receptors represent key targets for drugs against several neuronal diseases with excitotoxicity as a contributing mechanism, such as Parkinson's and Alzheimer disease, as well as for the therapy of CNS-controlled disease symptoms, such as coughing.

Glutamate NMDA receptors are transmembrane, excitatory cell surface receptors at the level of the CNS and pancreatic islets. NMDA antagonists thus exert a preponderantly antiexcitatory effect on the CNS and decrease the central activation of the adrenal gland. This potentially leads to indirect effects on pancreatic cells and insulin secretion, but even direct effects on pancreatic ß-cells have been suggested by the antagonism of pancreatic NMDA receptors.

Being tested
Dextromethorphan hydrobromide, Amantadine, Pacebo 1 (placebo for Amantadine), Placebo 2 (fo Dextromethorphan)
Keywords
dextromethorphan, amantadine, blood glucose lowering effect, oral glucose tolerance test
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dextromethorphan hydrobromideDrug

    Also called Dextromethorphan, Ratiopharm GmbH

    Dextromethorphan hydrobromide•1 H2O; 30 mg; hard capsules; single, oral dose.

  • AmantadineDrug

    Also called Amantadine, STADA Arzneimittel AG.

    Amantadine hydrochloride 100 mg; tablets; single, oral dose.

  • Pacebo 1 (placebo for Amantadine)Drug

    Also called P-Tabletten weiß 10 mm Lichtenstein, Winthrop Arzneimittel.

    Talets for oral use; single dose.

  • Placebo 2 (fo Dextromethorphan)Drug

    Also called Empty capsules, Capsugel Bornem Belgium.

    Capsles for oral administration; single dose.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the blood glucose (BG) concentration-time profile

    Measured: from 1-3 hours post-dose (i.e. from 0-2 hours after an OGTT)

Secondary outcomes (2)

  1. Area under the blood glucose concentration-time profile

    Measured: 0-1 hour post-dose (i.e. before starting the OGTT)

  2. Adverse events

    Measured: 5 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01441986
Sponsor's protocol ID
0533-DXM
Acronym
DXM/AMT
Status last verified
Jul 2012
First submitted
22 Sep 2011
Last updated
12 Jul 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dextromethorphan hydrobromide and Amantadine in people with Type 2 Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the blood glucose (BG) concentration-time profile (time frame: from 1-3 hours post-dose (i.e. from 0-2 hours after an OGTT)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01441986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in