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

NCT00525577 | Unknown Phase 2 DMC

• 1 other identifier: AGI-1067-052
• Study Type: interventional
• Target: 1,012
• Locations: 8 countries
• Sites: 90

Brief 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. Glycemic control will be measured during a 6-month treatment period in subjects who are on 1 or no antidiabetic drugs

Conditions

Diabetes

Keywords

Type 2 diabetes, glycemic control

Outcome Measures

Primary Outcomes (1)

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

  6 month

Secondary Outcomes (1)

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

  6 month

Study Arms (3)

1:A

EXPERIMENTAL

Placebo

Drug: Placebo

2:B

EXPERIMENTAL

AGI-1067 75 mg

Drug: AGI-1067

3:C

EXPERIMENTAL

AGI-1067 150 mg

Drug: AGI-1067

Interventions

Placebo DRUG

Placebo tablet, once daily

1:A

AGI-1067 DRUG

75 mg AGI-1067 tablet, once daily

Also known as: AGI-1067 (succinobucol)

2:B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.)

Sponsors & Collaborators

• AtheroGenics: lead

Study Sites (90)

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Diabetes and Glandular Disease

San Antonio, Texas, 78237, United States

Location

Clinic for the Internal Medicine-Clinical Center Banja Luka

Banja Luka, Bosnia and Herzegovina

Location

Center of Endocrinology, Metabology & Nutriology

Tbilisi, Georgia

Location

Diagnostic Services Ltd.

Tbilisi, Georgia

Location

Georgian Diabetes Center

Tbilisi, Georgia

Location

Healthy Life Center

Tbilisi, Georgia

Location

Institute of Cardiology

Tbilisi, Georgia

Location

Tbilisi Center of Endocrinology

Tbilisi, Georgia

Location

Tbilisi State Medical University Clinic #1

Tbilisi, Georgia

Location

Second floor , Silver Brook Building,

Ahmedabad, India

Location

Shantiniketan Hospital

Ahmedabad, India

Location

Bangalore Diabetes

Bangalore, India

Location

Bhagwan Mahaveer Jain Hospital

Bangalore, India

Location

M.s. Ramaiah Memorial Hospital

Bangalore, India

Location

St. Johns Medical College and Hospital,

Bangalore, India

Location

Belgaum Diabetes Centre

Belagavi, India

Location

Dr. V Seshiah Diabetes Care and Research Institute

Chennai, India

Location

Madras Research Center

Chennai, India

Location

Sri Ramachandra Medical Centre

Chennai, India

Location

Mediciti Hospital, 5-9-22

Hyderabaad, India

Location

Medwin Hospitals

Hyderabaad, India

Location

Sai's Endocrine and Growth Centre

Hyderabaad, India

Location

Diabetes, Thyroid and Endocrine

Jaipur, India

Location

Saytam Hospital and Research Centre

Jaipur, India

Location

Amrita Institute of Medical Sciences

Kochi, India

Location

Dayanand Medical College & Hospital

Ludhiana, India

Location

IRL-Synexus Clinical Research Centre

Mumbai, India

Location

Medicine C Railway Hospital, Byculla

Mumbai, India

Location

T.N.M. College & BYL Nair CH

Mumbai, India

Location

TMMC&LTMGH, Sion Hospital

Mumbai, India

Location

All India Institute of Medical Sciences

New Dehli, India

Location

Apollo Health Education Research and Foundation(AHERF)

New Dehli, India

Location

Fortis Flt. Lt. Rajan Dhall Hospital

New Dehli, India

Location

Maulana Azad Medical College and Lok Nayak Hospital

New Dehli, India

Location

Sir Ganga Ram Hospital

New Dehli, India

Location

Jehangir Hospital

Pune, India

Location

Orange Diabetes Speciality Clinic

Pune, India

Location

SUT Hospital

Trivandrum, India

Location

Endocrine & Diabetes Centre

Visakhapatnam, India

Location

Clinical Hospital "Dr. Trifun Panovski"

Bitola, North Macedonia

Location

General Hospital, Kumanovo

Kumanovo, North Macedonia

Location

General Hospital, Ohrid,

Ohrid, North Macedonia

Location

University Clinical Center Skopje

Skopje, North Macedonia

Location

Institute for Endocrinology, Diabetes and Metabolic-Clinical Center Serbia

Belgrade, Serbia and Montenegro

Location

Clinic for the Internal Medicine-Clinical Cente Bijelo Polje

Bijelo Polje, Serbia and Montenegro

Location

Clinic for the Internal Medicine-Clinical Cente Kotor

Kotor, Serbia and Montenegro

Location

Clinic for the Internal Medicine-Clinical Cente Kragujevac

Kragujevac, Serbia and Montenegro

Location

Clinic of endocrinologyClinical Center Nis

Nis, Serbia and Montenegro

Location

Clinic for the Internal Medicine-Clinical Center Podgorica

Podgorica, Serbia and Montenegro

Location

Josha Research, Rubins Building

Bloemfontein, South Africa

Location

Quinta Research

Bloemfontein, South Africa

Location

21 Concert Boulevard

Cape Town, South Africa

Location

Brooklyn Medical Centre

Cape Town, South Africa

Location

Paarl Research Centre, Medicross Paarl

Cape Town, South Africa

Location

Tiervlei Trial Centre, Karl Bremer Hospital

Cape Town, South Africa

Location

TREAD Research Tygerberg Hosp

Cape Town, South Africa

Location

8 Flamco Terrace

Chatsworth, South Africa

Location

203 Maxwell Centre

Durban, South Africa

Location

700 Medi Centre

Durban, South Africa

Location

Mount Edgecombe Medical Centre, Suite 15

Durban, South Africa

Location

Randles Rd Medical Centre

Durban, South Africa

Location

1644 Starling Street

Johannesburg, South Africa

Location

Centre for Diabetes & Endocrinology

Johannesburg, South Africa

Location

DJW Navorsing

Johannesburg, South Africa

Location

Melrose Arch

Johannesburg, South Africa

Location

Seva Sadan, Room 6

Johannesburg, South Africa

Location

Union Hospital, Room 209

Johannesburg, South Africa

Location

Wits Donald Gordon Clinical Trial Site

Johannesburg, South Africa

Location

Mercantile Hospital

Port Elizabeth, South Africa

Location

122 Louis Pasteur Building

Pretoria, South Africa

Location

456 Leyd Steer

Pretoria, South Africa

Location

Eastmed Medical Centre

Pretoria, South Africa

Location

GCT Trial Centre Jubilee, Jubilee Hospital

Pretoria, South Africa

Location

The Bay Hospital, Suite M5

Richards Bay, South Africa

Location

Helderberg Diabetes and Medical Centre

Somerset West, South Africa

Location

14 Medgate Medical Centre

Umhlanga, South Africa

Location

Department of Endocrinology of Bukovina State Medical University

Chernivtsy, Ukraine

Location

Institute of Problem of Endocrinological Pathology UAMS.

Kharkiv, Ukraine

Location

Kharkov Regional Clinical Hospital

Kharkiv, Ukraine

Location

Bogomolets National Medical University

Kiev, Ukraine

Location

Department of Endocrinology, Scientific Center of Radiation Medicine

Kiev, Ukraine

Location

Komisarenko Institute of Endocrinology and Metabolism of UAMS

Kiev, Ukraine

Location

Ukrainian Scientific and Practical Center of Endocrinology Surgery

Kiev, Ukraine

Location

Lviv Regional Endocrinology Health Center

Lviv, Ukraine

Location

Odessa State Medical University.

Odesa, Ukraine

Location

M.V. Sklifosovskiy Regional Clinical Hospital.

Poltava, Ukraine

Location

Semashko Republic Clinical Hospital

Simferopol, Ukraine

Location

Reginal Clinical Endocrinological Health Center

Vinnitsa, Ukraine

Location

Basin Clinical Hospital

Zaporizhya, Ukraine

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

succinobucol

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Walker Long, MD

  AtheroGenics, Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 6, 2007
• Study Start: August 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: September 1, 2008
• Last Updated: February 6, 2008

Record last verified: 2008-02

Locations

NO (4); BO (1); SE (6); US (2); ZA (27); UA (13); GE (7); IN (30)