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DiabetesPhase 2/3ANDESNCT00525577

ANDES-AGI-1067 as a Novel Antidiabetic Agent Evaluation Study

A Phase 2/3 study testing AGI-1067 in people with Diabetes, run by AtheroGenics at 90 sites in 8 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This double-blind, placebo-controlled, dose-finding study is designed to identify the lowest AGI-1067 dose that improves glycemic control as measured by HbA1c and fasting glucose in subjects with Type 2 diabetes mellitus. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes
What is being tested?
AGI-1067
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,012 participants
Where
90 sitesin 8 countries
Study dates
Aug 2007to Sep 2008
Phase
Phase 2/3
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide informed written consent prior to entry.
  • Be male or female 18-75 years of age at the time of entry and have Type 2 diabetes for a minimum of 6 months prior to Screening 1 visit.
  • Have an HbA1c level measured at the Screening 1 and Screening 2 visits with a minimum level at ≥7.5% for both visits, as determined by the core lab analysis.
  • Be taking either 1 or no antidiabetic agents. If on an antidiabetic medication, it must be of the sulphonylurea, metformin, or glitazone class, and the dosage must have been stable for the last 3 months prior to the Screening 1 visit. Note that no combination medications (i.e., counted as more than 1 agent) will be permitted prior to Randomization and that the use of GLP mimetrics, DPPIV inhibitors, or colesevelam are not permitted (rescue medication will be allowed at 3 months).
  • Subjects who are using hormone replacement therapy must have been on stable doses of their hormone replacement therapy for at least 3 months prior to the Screening 1 visit.
  • Females must not be breast feeding or pregnant. If they are of child-bearing potential, they must be using a reliable method of birth control considered suitable by the Investigator. If on hormonal contraceptives for more than 6 months, subjects will be allowed to participate in the study provided that this therapy remains constant throughout the study and for a period of 2 months after the end of the study.

Who cannot join

  • Have Type 1 diabetes or history of ketoacidosis determined by medical history
  • Have an HbA1c of more than 10.5% or a fasting glucose of >240 mg/dL (13.3 mmol/L) at either the Screening 1 [Visit 1] or Screening 2 [Visit 2])
  • Have a history of severe diabetic neuropathy including autonomic neuropathy, gastroparesis, or lower limb ulceration or amputation.
  • Have a history of long-term therapy with insulin (>30 days) within the last year or >7 days within the last 3 months.
  • Require parenteral corticosteroids or recurrent continuous oral corticosteroid treatment (>2 weeks) within the last 3 months.
  • Use weight loss drugs (e.g., orlistat, sibutramine, phenylpropanolamine, phentermine, or similar prescription or over-the-counter medications) within 3 months of the Screening 1 visit or intentional weight loss of ≥4 kg in the previous 6 months.
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  • Have had a new antidiabetic medication added, or the dose of an existing antidiabetic medication changed, in the last 3 months prior to the Screening 1 visit.
  • Have had a stroke, MI, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA), or admission with unstable angina within the last 6 months prior to the Screening 1 visit.
  • Have congestive heart failure New York Heart Association Class III or IV (Appendix B).
  • Have taken any of the following drugs in 6 months prior to the Screening 1 visit: cholestyramine, colestid, cyclosporine, or isotretinoin.
  • Have acute infections requiring parenteral antibiotic treatment within the last 3 months.
  • Have uncontrolled hypertension (defined as systolic blood pressure >180 mmHg).
  • Have platelets <100,000 K/cu mm (x 103/μL) at the Screening 1 visit.
  • Have active liver disease or hepatic dysfunction (total bilirubin, aspartate aminotransferase [AST], alanine aminotransferase [ALT] >1.5 times upper limit of normal [ULN]) as determined by core lab analysis at either the Screening 1 visit or the Screening 2 visits.
  • Subjects with long QT syndrome as evidence by a QTc at the Screening 1 visit of >460 msec in males or >480 msec in females or subjects taking and requiring continued therapy with antiarrhythmic medications such as sotalol, quinidine, dofetilide, amiodarone or other drugs known to significantly prolong the QT interval (this will not include drugs associated with minor effect on the QT interval of less than 15 msec.)
  • Have known major chronic infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the Investigator (including diabetes mellitus too severe to allow the subject to safely participate in this study).
  • Have had a life-threatening illness or any history of cancer or malignancy within the past 5 years (except for basal cell carcinoma).
  • Have had surgery requiring inpatient admission within 30 days prior to the Screening 1 visit.
  • Considered unreliable as a study participant based on the Investigator's (or designee's) knowledge of the subject (e.g., history of alcohol or other drug abuse, inability or unwillingness to adhere to the protocol, or psychosis).
  • Have a history of intolerance or previous use of probucol within the last 5 years.
  • Have participated in a previous study with AGI-1067.
  • Have participated in any investigational drug study within 30 days prior to study entry, or expects to participate in any other investigational drug study during the course of ANDES.

Trial locations and contacts

90 sites in 8 countries.

90 sites in 8 countries

India30 sites

  • Second floor , Silver Brook Building,

    Ahmedabad

  • Shantiniketan Hospital

    Ahmedabad

  • Bangalore Diabetes

    Bangalore

  • Bhagwan Mahaveer Jain Hospital

    Bangalore

  • M.s. Ramaiah Memorial Hospital

    Bangalore

  • St. Johns Medical College and Hospital,

    Bangalore

  • Belgaum Diabetes Centre

    Belagavi

  • Dr. V Seshiah Diabetes Care and Research Institute

    Chennai

  • Madras Research Center

    Chennai

  • Sri Ramachandra Medical Centre

    Chennai

  • Mediciti Hospital, 5-9-22

    Hyderabaad

  • Medwin Hospitals

    Hyderabaad

  • Sai's Endocrine and Growth Centre

    Hyderabaad

  • Diabetes, Thyroid and Endocrine

    Jaipur

  • Saytam Hospital and Research Centre

    Jaipur

  • Amrita Institute of Medical Sciences

    Kochi

  • Dayanand Medical College & Hospital

    Ludhiana

  • IRL-Synexus Clinical Research Centre

    Mumbai

  • Medicine C Railway Hospital, Byculla

    Mumbai

  • T.N.M. College & BYL Nair CH

    Mumbai

  • TMMC&LTMGH, Sion Hospital

    Mumbai

  • All India Institute of Medical Sciences

    New Dehli

  • Apollo Health Education Research and Foundation(AHERF)

    New Dehli

  • Fortis Flt. Lt. Rajan Dhall Hospital

    New Dehli

  • Maulana Azad Medical College and Lok Nayak Hospital

    New Dehli

  • Sir Ganga Ram Hospital

    New Dehli

  • Jehangir Hospital

    Pune

  • Orange Diabetes Speciality Clinic

    Pune

  • SUT Hospital

    Trivandrum

  • Endocrine & Diabetes Centre

    Visakhapatnam

Other trials in India

South Africa27 sites

  • Josha Research, Rubins Building

    Bloemfontein

  • Quinta Research

    Bloemfontein

  • 21 Concert Boulevard

    Cape Town

  • Brooklyn Medical Centre

    Cape Town

  • Paarl Research Centre, Medicross Paarl

    Cape Town

  • Tiervlei Trial Centre, Karl Bremer Hospital

    Cape Town

  • TREAD Research Tygerberg Hosp

    Cape Town

  • 8 Flamco Terrace

    Chatsworth

  • 203 Maxwell Centre

    Durban

  • 700 Medi Centre

    Durban

  • Mount Edgecombe Medical Centre, Suite 15

    Durban

  • Randles Rd Medical Centre

    Durban

  • 1644 Starling Street

    Johannesburg

  • Centre for Diabetes & Endocrinology

    Johannesburg

  • DJW Navorsing

    Johannesburg

  • Melrose Arch

    Johannesburg

  • Seva Sadan, Room 6

    Johannesburg

  • Union Hospital, Room 209

    Johannesburg

  • Wits Donald Gordon Clinical Trial Site

    Johannesburg

  • Mercantile Hospital

    Port Elizabeth

  • 122 Louis Pasteur Building

    Pretoria

  • 456 Leyd Steer

    Pretoria

  • Eastmed Medical Centre

    Pretoria

  • GCT Trial Centre Jubilee, Jubilee Hospital

    Pretoria

  • The Bay Hospital, Suite M5

    Richards Bay

  • Helderberg Diabetes and Medical Centre

    Somerset West

  • 14 Medgate Medical Centre

    Umhlanga

Other trials in South Africa

Ukraine13 sites

  • Department of Endocrinology of Bukovina State Medical University

    Chernivtsy

  • Institute of Problem of Endocrinological Pathology UAMS.

    Kharkiv

  • Kharkov Regional Clinical Hospital

    Kharkiv

  • Bogomolets National Medical University

    Kiev

  • Department of Endocrinology, Scientific Center of Radiation Medicine

    Kiev

  • Komisarenko Institute of Endocrinology and Metabolism of UAMS

    Kiev

  • Ukrainian Scientific and Practical Center of Endocrinology Surgery

    Kiev

  • Lviv Regional Endocrinology Health Center

    Lviv

  • Odessa State Medical University.

    Odesa

  • M.V. Sklifosovskiy Regional Clinical Hospital.

    Poltava

  • Semashko Republic Clinical Hospital

    Simferopol

  • Reginal Clinical Endocrinological Health Center

    Vinnitsa

  • Basin Clinical Hospital

    Zaporizhya

Other trials in Ukraine

Georgia7 sites

  • Center of Endocrinology, Metabology & Nutriology

    Tbilisi

  • Diagnostic Services Ltd.

    Tbilisi

  • Georgian Diabetes Center

    Tbilisi

  • Healthy Life Center

    Tbilisi

  • Institute of Cardiology

    Tbilisi

  • Tbilisi Center of Endocrinology

    Tbilisi

  • Tbilisi State Medical University Clinic #1

    Tbilisi

Other trials in Georgia

Serbia and Montenegro6 sites

  • Institute for Endocrinology, Diabetes and Metabolic-Clinical Center Serbia

    Belgrade

  • Clinic for the Internal Medicine-Clinical Cente Bijelo Polje

    Bijelo Polje

  • Clinic for the Internal Medicine-Clinical Cente Kotor

    Kotor

  • Clinic for the Internal Medicine-Clinical Cente Kragujevac

    Kragujevac

  • Clinic of endocrinologyClinical Center Nis

    Nis

  • Clinic for the Internal Medicine-Clinical Center Podgorica

    Podgorica

Other trials in Serbia and Montenegro

North Macedonia4 sites

  • Clinical Hospital "Dr. Trifun Panovski"

    Bitola

  • General Hospital, Kumanovo

    Kumanovo

  • General Hospital, Ohrid,

    Ohrid

  • University Clinical Center Skopje

    Skopje

Other trials in North Macedonia

United States2 sites

  • Diabetes and Glandular Disease

    San Antonio, Texas, 78237

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

Other trials in United States

Bosnia and Herzegovina1 site

  • Clinic for the Internal Medicine-Clinical Center Banja Luka

    Banja Luka

Other trials in Bosnia and Herzegovina

About this study

Official title: AGI-1067 as a Novel Antidiabetic Agent Evaluation Study

This double-blind, placebo-controlled, dose-finding study is designed to identify the lowest AGI-1067 dose that improves glycemic control as measured by HbA1c and fasting glucose in subjects with Type 2 diabetes mellitus. Glycemic control will be measured during a 6-month treatment period in subjects who are on 1 or no antidiabetic drugs

Conditions
Diabetes
Being tested
Placebo, AGI-1067
Keywords
Type 2 diabetes, glycemic control
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

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

  • PlaceboDrug

    Placebo tablet, once daily

  • AGI-1067Drug

    Also called AGI-1067 (succinobucol)

    75 mg AGI-1067 tablet, once daily

  • AGI-1067Drug

    Also called AGI-1067 (succinobucol)

    150 mg AGI-1067 Tablet, once daily

Study groups in NCT00525577
Study groupRoleWhat they receive
1:AExperimentalPlacebo
Receives: Drug: Placebo
2:BExperimentalAGI-1067 75 mg
Receives: Drug: AGI-1067
3:CExperimentalAGI-1067 150 mg
Receives: Drug: AGI-1067

What is being measured

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

  1. Change from baseline in HbA1c to the 6-month time point is identical in the study groups (placebo and AGI-1067 treatment groups)

    Measured: 6 month

Secondary outcomes (1)

  1. • Change of HbA1c from baseline throughout the study • Change of FPG from baseline throughout the study•

    Measured: 6 month

Timeline

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

  1. First posted6 Sep 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionJun 2008 (estimated)
  4. Study completionSep 2008 (estimated)

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,012 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00525577
Sponsor's protocol ID
AGI-1067-052
Acronym
ANDES
Status last verified
Feb 2008
First submitted
4 Sep 2007
Last updated
6 Feb 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing AGI-1067 in people with Diabetes, run by AtheroGenics at 90 sites in 8 countries.

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 6 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: status not confirmed, as of the sponsor's last update on 6 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in India, South Africa, Ukraine, Georgia, Serbia and Montenegro and 3 more countries. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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?

Change from baseline in HbA1c to the 6-month time point is identical in the study groups (placebo and AGI-1067 treatment groups) (time frame: 6 month). 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 NCT00525577.

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 6 Feb 2008.

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