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

Diabetes Clinical Trial

— ANDES  

Official title:

AGI-1067 as a Novel Antidiabetic Agent Evaluation Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00525577
• Other study ID #: AGI-1067-052
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: September 4, 2007
• Last updated: February 4, 2008
• Start date: August 2007
• Est. completion date: September 2008

Study information

• Verified date: February 2008
• Source: AtheroGenics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth Africa: Medicines Control CouncilIndia: Ministry of HealthGeorgia: Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal DevicesUkraine: Ministry of HealthMacedonia: Ethics CommitteeRussia: Pharmacological Committee, Ministry of Health
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1012
• Est. completion date: September 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Provide informed written consent prior to entry.

2. 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.

3. 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.

4. 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).

5. 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.

6. 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.

Exclusion Criteria:

1. Have Type 1 diabetes or history of ketoacidosis determined by medical history

2. 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])

3. Have a history of severe diabetic neuropathy including autonomic neuropathy, gastroparesis, or lower limb ulceration or amputation.

4. Have a history of long-term therapy with insulin (>30 days) within the last year or >7 days within the last 3 months.

5. Require parenteral corticosteroids or recurrent continuous oral corticosteroid treatment (>2 weeks) within the last 3 months.

6. 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.

7. 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.

8. 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.

9. Have congestive heart failure New York Heart Association Class III or IV (Appendix B).

10. Have taken any of the following drugs in 6 months prior to the Screening 1 visit:

cholestyramine, colestid, cyclosporine, or isotretinoin.

11. Have acute infections requiring parenteral antibiotic treatment within the last 3 months.

12. Have uncontrolled hypertension (defined as systolic blood pressure >180 mmHg).

13. Have platelets <100,000 K/cu mm (x 103/µL) at the Screening 1 visit.

14. 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.

15. 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.)

16. 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).

17. Have had a life-threatening illness or any history of cancer or malignancy within the past 5 years (except for basal cell carcinoma).

18. Have had surgery requiring inpatient admission within 30 days prior to the Screening 1 visit.

19. 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).

20. Have a history of intolerance or previous use of probucol within the last 5 years.

21. Have participated in a previous study with AGI-1067.

22. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Placebo
Placebo tablet, once daily
• AGI-1067
75 mg AGI-1067 tablet, once daily
• AGI-1067
150 mg AGI-1067 Tablet, once daily

Locations

Country	Name	City	State
Bosnia and Herzegovina	Clinic for the Internal Medicine-Clinical Center Banja Luka	Banja Luka
Former Serbia and Montenegro	Institute for Endocrinology, Diabetes and Metabolic-Clinical Center Serbia	Belgrade
Former Serbia and Montenegro	Clinic for the Internal Medicine-Clinical Cente Bijelo Polje	Bijelo Polje
Former Serbia and Montenegro	Clinic for the Internal Medicine-Clinical Cente Kotor	Kotor
Former Serbia and Montenegro	Clinic for the Internal Medicine-Clinical Cente Kragujevac	Kragujevac
Former Serbia and Montenegro	Clinic of endocrinologyClinical Center Nis	Nis
Former Serbia and Montenegro	Clinic for the Internal Medicine-Clinical Center Podgorica	Podgorica
Georgia	Center of Endocrinology, Metabology & Nutriology	Tbilisi
Georgia	Diagnostic Services Ltd.	Tbilisi
Georgia	Georgian Diabetes Center	Tbilisi
Georgia	Healthy Life Center	Tbilisi
Georgia	Institute of Cardiology	Tbilisi
Georgia	Tbilisi Center of Endocrinology	Tbilisi
Georgia	Tbilisi State Medical University Clinic #1	Tbilisi
India	Second floor , Silver Brook Building,	Ahmedabad
India	Shantiniketan Hospital	Ahmedabad
India	Bangalore Diabetes	Bangalore
India	Bhagwan Mahaveer Jain Hospital	Bangalore
India	M.s. Ramaiah Memorial Hospital	Bangalore
India	St. Johns Medical College and Hospital,	Bangalore
India	Belgaum Diabetes Centre	Belgaum
India	Dr. V Seshiah Diabetes Care and Research Institute	Chennai
India	Madras Research Center	Chennai
India	Sri Ramachandra Medical Centre	Chennai
India	Amrita Institute of Medical Sciences	Cochin
India	Mediciti Hospital, 5-9-22	Hyderabaad
India	Medwin Hospitals	Hyderabaad
India	Sai's Endocrine and Growth Centre	Hyderabaad
India	Diabetes, Thyroid and Endocrine	Jaipur
India	Saytam Hospital and Research Centre	Jaipur
India	Dayanand Medical College & Hospital	Ludhiana
India	IRL-Synexus Clinical Research Centre	Mumbai
India	Medicine C Railway Hospital, Byculla	Mumbai
India	T.N.M. College & BYL Nair CH	Mumbai
India	TMMC&LTMGH, Sion Hospital	Mumbai
India	All India Institute of Medical Sciences	New Dehli
India	Apollo Health Education Research and Foundation(AHERF)	New Dehli
India	Fortis Flt. Lt. Rajan Dhall Hospital	New Dehli
India	Maulana Azad Medical College and Lok Nayak Hospital	New Dehli
India	Sir Ganga Ram Hospital	New Dehli
India	Jehangir Hospital	Pune
India	Orange Diabetes Speciality Clinic	Pune
India	SUT Hospital	Trivandrum
India	Endocrine & Diabetes Centre	Visakhapatnam
Macedonia, The Former Yugoslav R	Clinical Hospital "Dr. Trifun Panovski"	Bitola
Macedonia, The Former Yugoslav R	General Hospital, Kumanovo	Kumanovo
Macedonia, The Former Yugoslav R	General Hospital, Ohrid,	Ohrid,
Macedonia, The Former Yugoslav R	University Clinical Center Skopje	Skopje
South Africa	Josha Research, Rubins Building	Bloemfontein
South Africa	Quinta Research	Bloemfontein
South Africa	21 Concert Boulevard	Cape Town
South Africa	Brooklyn Medical Centre	Cape Town
South Africa	Paarl Research Centre, Medicross Paarl	Cape Town
South Africa	Tiervlei Trial Centre, Karl Bremer Hospital	Cape Town
South Africa	TREAD Research Tygerberg Hosp	Cape Town
South Africa	8 Flamco Terrace	Chatsworth
South Africa	203 Maxwell Centre	Durban
South Africa	700 Medi Centre	Durban
South Africa	Mount Edgecombe Medical Centre, Suite 15	Durban
South Africa	Randles Rd Medical Centre	Durban
South Africa	1644 Starling Street	Johannesburg
South Africa	Centre for Diabetes & Endocrinology	Johannesburg
South Africa	DJW Navorsing	Johannesburg
South Africa	Melrose Arch	Johannesburg
South Africa	Seva Sadan, Room 6	Johannesburg
South Africa	Union Hospital, Room 209	Johannesburg
South Africa	Wits Donald Gordon Clinical Trial Site	Johannesburg
South Africa	Mercantile Hospital	Port elizabeth
South Africa	122 Louis Pasteur Building	Pretoria
South Africa	456 Leyd Steer	Pretoria
South Africa	Eastmed Medical Centre	Pretoria
South Africa	GCT Trial Centre Jubilee, Jubilee Hospital	Pretoria
South Africa	The Bay Hospital, Suite M5	Richards Bay
South Africa	Helderberg Diabetes and Medical Centre	Somerset West
South Africa	14 Medgate Medical Centre	Umhlanga
Ukraine	Department of Endocrinology of Bukovina State Medical University	Chernivtsy
Ukraine	Institute of Problem of Endocrinological Pathology UAMS.	Kharkov
Ukraine	Kharkov Regional Clinical Hospital	Kharkov
Ukraine	Bogomolets National Medical University	Kiev
Ukraine	Department of Endocrinology, Scientific Center of Radiation Medicine	Kiev
Ukraine	Komisarenko Institute of Endocrinology and Metabolism of UAMS	Kiev
Ukraine	Ukrainian Scientific and Practical Center of Endocrinology Surgery	Kiev
Ukraine	Lviv Regional Endocrinology Health Center	Lviv
Ukraine	Odessa State Medical University.	Odessa
Ukraine	M.V. Sklifosovskiy Regional Clinical Hospital.	Poltava
Ukraine	Semashko Republic Clinical Hospital	Simferopol
Ukraine	Reginal Clinical Endocrinological Health Center	Vinnitsa
Ukraine	Basin Clinical Hospital	Zaporizhya
United States	Diabetes and Glandular Disease	San Antonio	Texas
United States	Clinical Research Atlanta	Stockbridge	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
AtheroGenics

Countries where clinical trial is conducted

United States,  Bosnia and Herzegovina,  Former Serbia and Montenegro,  Georgia,  India,  Macedonia, The Former Yugoslav Republic of,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	• Change of HbA1c from baseline throughout the study • Change of FPG from baseline throughout the study•		6 month	No