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Metabolic Cardiovascular SyndromePhase 1/2NCT01408667

Hyperinsulinemic Euglycemic Clamp Protocol

A Phase 1/2 study testing TRC150094 in people with Metabolic Cardiovascular Syndrome, run by Torrent Pharmaceuticals Limited at 1 site in Netherlands.

Completed

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

Official record
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Trial summary

The purpose of the study is to determine the safety and efficacy of TRC150094 in male patients with cardiometabolic risk. Cardiometabolic risk which is the overall risk of cardiovascular disease (CVD) and diabetes resulting from the presence of hypertension, HDL cholesterol, insulin resistance, dysglycemia and… Read more about this study

Who is it for?
Ages 30 to 65 years, men only
Conditions the study is for
Metabolic Cardiovascular Syndrome
What is being tested?
TRC150094
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteNetherlands
Study dates
Nov 2011to Mar 2012
Phase
Phase 1/2
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 30 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects will be considered eligible for entry in the study if they meet all of the following criteria.
  • Adult male
  • Age range 30-65 years at screening
  • Caucasian or Indian ethnicity
  • Waist circumference ≥ 102 cm for Caucasians and ≥ 90 cm for Indians at screening.
  • Fasting Serum Insulin ≥ 10 mU/ml at screening
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  • Blood Pressure ≥ 130/85 mmHg at screening (or patients taking medication for hypertension)
  • Stable weight during 3 months prior to the study (assessed through medical history of the patient)
  • Drug naive diabetic patients* or patients with impaired fasting glucose i.e > 100 mg/dl or 5.5 mmol/l and < 200 mg/dl or 11.0 mmol/l Diabetic patients who were taking metformin and have undergone washout for at least 4 weeks before Day 0 and are currently on life style modification as a treatment for diabetes will also be allowed in the study
  • Willingness to give written informed consent (prior to any study-related procedures being performed) and ability to adhere to the study restrictions and assessments schedule.
  • Diabetic patient is defined as a patient with a documented history of type II DM or a documented history of a fasting glucose > 200mg/dl or 11.0 mmol/l or 2x fasting glucose > 126 mg/dl or 6.9 mmol/l (2x =recorded twice).

Who cannot join

  • Subjects will not be considered eligible for entry in the study if they meet one or more of the following criteria.
  • Medical history, physical examination, vital signs, clinical laboratory tests, 12-lead ECG and Chest X ray (to exclude tuberculosis in India only) with any significant abnormalities, in the opinion of the investigator.
  • Subjects with any known somatic illness, including neoplasm, endocrine disorder such as cushing's disease, PCOD and uncontrolled hypothyroidism, neurologic disorder, active infection, or recent surgical procedure within 3 months of the study initiation.
  • Subject currently using medication, which can influence glucose or FFA metabolism such as fibrates, niacin, ACE inhibitors, PPAR agonists, omega 3 fatty acids.
  • eGFR < 60 mL/min/1.73m2 at screening as evaluated by Modification of Diet in Renal Disease (MDRD) method.
  • History of angina, Myocardial Infarction (MI) or stroke since last 6 months.
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  • Hypertension with SBP/DBP ≥160/100 mmHg at screening.
  • ALT or AST ≥ ULN*3 at screening
  • History or presence of malignancy.
  • History of recreational drug use within the last 30 days, or regular consumption of greater than 2 units of alcohol/day.
  • History of allergy to the test drug or any drug chemically similar to the drug under investigation.
  • Seropositive for Hepatitis B, Hepatitis C or HIV.
  • Subjects suffering from any psychiatric (acute or chronic) illness.
  • Intake of any medication except those permitted in this study (see Section 6.6).
  • Intake of any investigational drug in the period within 3 months prior to the first dose of study drug.
  • History of significant blood loss due to any reason, including blood donation, in the 12 weeks prior to the first dose of study drug; or the total blood loss in the last 3 months, including for this study, exceeds 450 mL.
  • History of any bleeding disorder.
  • Existence of any surgical or medical condition which, in the judgment of the principal investigator, might interfere with the absorption, distribution, metabolism or excretion of the study drug or might be likely to compromise the safety of the subject.
  • Inability to communicate or co-operate with the investigator because of language problems, poor mental development or impaired cerebral function.
  • Inability to comply with study requirements.
  • Positive drugs of abuse test (at screening) and alcohol breath test.
  • Heavy smokers (who are smoking >15 cigarettes or equivalent per day).

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Academic Medical Centre,

    Amsterdam, Amsterdam, 1100 DD

Other trials in Netherlands

About this study

Official title: A Phase 2A, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety and Efficacy of TRC150094 in Increasing Insulin Sensitivity in Male Patients With Increased Cardiometabolic Risk

The purpose of the study is to determine the safety and efficacy of TRC150094 in male patients with cardiometabolic risk. Cardiometabolic risk which is the overall risk of cardiovascular disease (CVD) and diabetes resulting from the presence of hypertension, HDL cholesterol, insulin resistance, dysglycemia and visceral obesity.

Read the detailed description

20 Subjects will be enrolled in Veeda Clinical research,India and another 20 subjects at Amsterdam, the Netherlands. The maximum duration of participation in the study for each subject will be 9.5 weeks including a less than or equal to 4 weeks screening period, 4 weeks of treatment and a 10 days post treatment follow-up evaluation period.

At each study site, 20 subjects will be enrolled. Each subject will attend the study centre in a fasting state, for a screening visit, 2 study visits (one baseline and one end of treatment), 1 intermediate safety visit and 1 post-study follow-up visit (Total 5 visits). The subjects at each site will be randomized to receive TRC150094 or placebo in a ratio of 1:1. 50 mg dose will be administered once daily (morning) under fasting conditions. Dosing will take place daily on Days 1-28. Subjects will arrive at the study centre for screening visit. Physical examination, vital signs, safety biochemistry and laboratory investigations for verification of inclusion/ exclusion criteria will be performed during screening visit. Subjects meeting all the inclusion criteria and none of the exclusion criteria and who have given their informed consent for the study will be asked to come for the study on Day 0 (or day -1 if required). Baseline investigations (including baseline clamp procedure and hepatic MRS) will be done on Day 0 (or day -1). Subjects will receive properly labelled bottle containing either Active treatment or Placebo as per the randomization number of the subject.

Being tested
TRC150094, Placebo
Keywords
insulin sensitivity, cardiometabolic risk, hyperinsulinemic euglycemic clamp
Medical subject headings
Metabolic Syndrome, Insulin Resistance

What participants receive

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

  • TRC150094Drug

    50 mg Tablets once a day

  • PlaceboOther

    Tablets once daily

Study groups in NCT01408667
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo
TRC150094Active comparatorNot described
Receives: Drug: TRC150094

What is being measured

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

  1. The safety of TRC150094 once daily dosing for 4 weeks in male patients with increased cardiometabolic risk will be determined.

    Safety parameters will include haematology, safety biochemistry, vital signs, ECG and AE check.

    Measured: 1 month

  2. The efficacy (in increasing insulin sensitivity) of TRC150094 once daily dosing for 4 weeks in male patients with increased cardiometabolic risk will be determined.

    Efficacy assessment will include Insulin Sensitivity to be determined by:

    Rate of Glucose Disposal Suppression of Endogenous Glucose Production Suppression of rate of lipolysis

    Measured: 1 month

Secondary outcomes (2)

  1. The effect of TRC150094 on hepatic fat and metabolic parameters will be evaluated.

    Early efficacy markers to be explored includes:

    • Hepatic fat by magnetic resonance spectroscopy
    • Lipid parameters
    • Metabolic markers such as adiponectin, IL-6, TNF-alpha, CRP, glucagon, leptin etc.

    Measured: 1 month

  2. The ethnic differences for effect of TRC150094 on Insulin sensitivity parameters will be evaluated.

    Difference in insulin sensitivity parameters (rate of glucose disposal) between caucasian and Indian populations.

    Measured: 1 month

Timeline

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

  1. First posted3 Aug 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionMar 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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01408667
Sponsor's protocol ID
CT/P015/CMR/2010/02_01
Other IDs
2011-002398-42
Status last verified
Jul 2012
First submitted
29 Jul 2011
Last updated
10 Jul 2012
Results posted
No
Data monitoring committee
No

Publications

  • Zambad SP, Munshi S, Dubey A, Gupta R, Busiello RA, Lanni A, Goglia F, Gupta RC, Chauthaiwale V, Dutt C. TRC150094 attenuates progression of nontraditional cardiovascular risk factors associated with obesity and type 2 diabetes in obese ZSF1 rats. Diabetes Metab Syndr Obes. 2011 Jan 6;4:5-16. doi: 10.2147/DMSOTT.S15323.

    PubMed 21448317

  • Cioffi F, Zambad SP, Chhipa L, Senese R, Busiello RA, Tuli D, Munshi S, Moreno M, Lombardi A, Gupta RC, Chauthaiwale V, Dutt C, de Lange P, Silvestri E, Lanni A, Goglia F. TRC150094, a novel functional analog of iodothyronines, reduces adiposity by increasing energy expenditure and fatty acid oxidation in rats receiving a high-fat diet. FASEB J. 2010 Sep;24(9):3451-61. doi: 10.1096/fj.10-157115. Epub 2010 May 7.

    PubMed 20453112

  • van der Valk F, Hassing C, Visser M, Thakkar P, Mohanan A, Pathak K, Dutt C, Chauthaiwale V, Ackermans M, Nederveen A, Serlie M, Nieuwdorp M, Stroes E. The effect of a diiodothyronine mimetic on insulin sensitivity in male cardiometabolic patients: a double-blind randomized controlled trial. PLoS One. 2014 Feb 21;9(2):e86890. doi: 10.1371/journal.pone.0086890. eCollection 2014.

    PubMed 24586256

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TRC150094 in people with Metabolic Cardiovascular Syndrome, run by Torrent Pharmaceuticals Limited at 1 site in Netherlands.

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 11 inclusion and 22 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 10 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The safety of TRC150094 once daily dosing for 4 weeks in male patients with increased cardiometabolic risk will be determined. (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT01408667, which also lists 3 linked publications.

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 10 Jul 2012; AzTrials last refreshed its copy on 27 Oct 2026.

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