Safety and Efficacy of BGP-15 in Patients With Type 2 Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

Randomized, Double-blind, Placebo-controlled, Parallel Group, Multiple Dose, Multicenter Study to Assess Safety & Efficacy of BGP-15 Administered Orally 1 or 2 Times Daily With Metformin & Sulfonylurea or Metformin in T2 Diabetic Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01069965
• Other study ID #: BGP-15-CLIN-IR04
• Secondary ID: 2009-013328-21
• Status: Terminated
• Phase: Phase 2
• First received: February 16, 2010
• Last updated: September 26, 2014
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: September 2014
• Source: N-Gene Research Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

This is a safety and dose finding efficacy study to evaluate the effects of BGP-15 over the dose range of 100 mg/day to 400 mg/day. Doses are applied once or twice a day for 13 weeks as add-on therapy to the combination of metformin and sulfonylurea treatment or metformin alone in patients with Type 2 Diabetes Mellitus.

Description:

This is a randomized, double-blind, placebo-controlled, parallel group, multiple dose, multicenter study with 5 treatment arms and 1 placebo arm. Patients should be treated with both metformin and SU or metformin alone. Patients will be randomized to 100,100 + 100, 200, 200 + 200, and 400 mg/day or placebo, as an add-on to their current treatment. The study consists of 2 periods:

• A 14-day screening period for ascertaining the inclusion/exclusion criteria; and,

• A 13-week treatment period with different doses of BGP-15 or placebo as an add-on therapy to metformin and SU treatment or metformin treatment alone.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 196
• Est. completion date: October 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion criteria

Patients meeting all of the following criteria will be eligible for enrollment:

1. Male and female patients with T2DM at time of diagnosis as defined by the American Diabetes Association (ADA) criteria;

2. Age between 30 and 70 years (inclusive);

3. HbA1c =7.5% - =12.0% at Screening, Visit 1;

4. FPG =270 mg/dL (15.0 mmol/L);

5. Body mass index (BMI) >27 and =40 kg/m2;

6. Current treatment with either metformin alone or in combination with SU. The dose of the current treatment must be stable for at least 8 weeks prior to randomization. Patients being treated with metformin must be at their optimal or near-optimal dose (=1500 mg/day ± 500 mg/day for a range of 1000 to 2000 mg/day), and patients being treated with SU must be receiving at least one half of the maximum approved SU dose;

7. Women may be enrolled if all three of the following criteria are met:

1. They have a negative serum pregnancy test at Screening;

2. They are not breast feeding; and,

3. They do not plan to become pregnant during the study AND if one of the following three criteria is met:

i. They have had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form; ii. They have been postmenopausal for at least 1 year; or, iii. They are of childbearing potential and will practice one of the following methods of birth control throughout the study: injectable or implantable hormonal contraception or intrauterine device; or two of the following methods of birth control throughout the study: oral or patch contraception plus a barrier contraceptive (eg, diaphragm plus spermicide, male or female condom plus spermicide, or vasectomized male partner). Abstinence, partner's use of condoms, and vasectomy are NOT acceptable methods of contraception;

8. Willingness to sign an informed consent document; and,

9. No conditions that hinder participation in the trial, as determined by the Investigator and Sponsor.

Exclusion criteria

Patients meeting any of the following criteria will be ineligible for enrollment:

1. Treatment with peroxisome proliferator-activated receptor (PPAR) agonists (including fibrates) within the last 3 months;

2. Treatment with dipeptidyl peptidase 4 (DPP-4) inhibitors, acarbose, or incretins within the last 3 months;

3. Chronic use of insulin injections within the last 1 month;

4. Hypoglycemia requiring third party assistance within the last 3 months;

5. Impaired hepatic function measured as alanine aminotransferase (ALAT) >2X the upper reference limit;

6. Impaired renal function measured as serum creatinine >150 umol/L (1.7 mg/dL);

7. Decompensated heart failure (New York Heart Association [NYHA] class III and IV);

8. Unstable angina pectoris or myocardial infarction within the last 12 months;

9. Clinically significant ECG abnormalities at screening including QTc interval (Bazett's) =450 msec or AV block >1st degree;

10. Uncontrolled, treated or untreated hypertension (systolic blood pressure [BP] =160 mmHg and/or diastolic BP =100 mmHg);

11. Any condition that the Investigator and/or Sponsor feel would interfere with trial participation or evaluation of the results eg, drug abuse or serious disease such as acquired immunodeficiency syndrome/human immunodeficiency syndrome (AIDS/HIV) antibodies, Hepatitis B, or Hepatitis C;

12. Pregnancy or breastfeeding, the intention to become pregnant, or judged to be using inadequate contraceptive measures;

13. History of alcohol and/or drug dependence within the last 2 years;

14. Receipt of any investigational drug or medical device within 3 months prior to this trial;

15. Fasting triglycerides >700 mg/dL at screening; or,

16. Diagnosis or treatment of cancer within the past 5 years except for excision of basal cell or squamous cell skin lesions.

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 Mellitus

Intervention

Drug:
• BGP-15 100 mg QD
Two 50 mg BGP-15 capsules by mouth in the morning; and two Placebo capsules by mouth in the evening
• BGP-15 100 mg BID
One 100 mg BGP-15 capsule by mouth in the morning; and one 100 mg BGP-15 capsule by mouth in the evening
• Placebo BID
Two Placebo capsules by mouth in the morning; and two Placebo capsules by mouth in the evening
• BGP-15 200 mg QD
Two 100 mg BGP-15 capsule by mouth in the morning; and two Placebo capsule by mouth in the evening
• BGP-15 200 mg BID
Two 100 mg BGP-15 capsules by mouth in the morning; and two 100 mg BGP-15 capsules by mouth in the evening
• BGP-15 400 mg QD
Two 200 mg BGP-15 capsules by mouth in the morning; and two Placebo capsules by mouth in the evening

Locations

Country	Name	City	State
Germany	Diabetespraxis Bad Mergentheim	Bad Mergentheim
Germany	Praxis Dr. Schätzl	Großheirath-Rossach
Germany	Universitätsklinikum Köln	Köln
Germany	Schwerpunktpraxis Diabetes	Neuwied
Germany	Diabetologische Schwerpunktpraxis	Siegen
Hungary	DRUG Research Center Hungary Kft.	Balatonfüred
Hungary	Semmelweis University 2nd Clinic for Internal Medicine	Budapest
Hungary	Petz Aladar Country Teaching Hospital, Dept of Diabetology and Metabolism	Gyor
Hungary	Dr. Bugyi Istvan Hospital, Diabetology Outpatient Clinic	Szentes
Hungary	Zala County Hospital Department of Diabetology	Zalaegerszeg
United States	Athens Medical Group	Athens	Tennessee
United States	ICCT Research International, Inc.	Chicago	Illinois
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Atlanta Pharmaceutical Research	Decatur	Georgia
United States	Creekside Endocrine Associates PC	Denver	Colorado
United States	Upstate Pharmaceutical Research	Greenville	South Carolina
United States	Mountain View Clinical Research	Greer	South Carolina
United States	Juno Research, LLC.	Houston	Texas
United States	Medstar Health Research Institute	Hyattsville	Maryland
United States	The Center for Pharmaceutical Research, P.C.	Kansas City	Missouri
United States	Juno Research, LLC.	Katy	Texas
United States	Nevada Alliance Against Diabetes	Las Vegas	Nevada
United States	Andrew J. Lewin Medical Corporation DBA National Research Institute	Los Angeles	California
United States	Center for Clinical Trials, LLC.	Paramount	California
United States	Cetero Research-San Antonio	San Antonio	Texas
United States	Southeastern Research Associates, Inc.	Taylors	South Carolina
United States	Orange County Research Center	Tustin	California
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida
United States	New Hanover Medical Research	Wilmington	North Carolina
United States	Piedmont Medical Research, LLC.	Winston-Salem	North Carolina

Sponsors (7)

Lead Sponsor	Collaborator
N-Gene Research Laboratories, Inc.	Barc NV, Haupt Pharma Wülfing GmbH, Integrium, Kinexum LLC, Msource Medical Development GmbH, Thermo Fisher Scientific

Countries where clinical trial is conducted

United States,  Germany,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Glycosylated Hemoglobin at Week 13		Baseline and Week 13	No
Secondary	Change from Baseline in Fasting Plasma Glucose at Weeks 4, 8, 13		Baseline and Weeks 4, 8, and 13	No
Secondary	Change from Baseline in Plasma Glucose at Week 13		Baseline and Week 13	No
Secondary	Cardiovascular and metabolic biomarkers at Baseline and 13 weeks		Baseline and Week 13	Yes