A Placebo Controlled Safety and Efficacy Study of INT131... | NCT00631007 | Trialant
NCT00631007
Sponsor
InteKrin Therapeutics, Inc.
Status
Completed
Last Update Posted
Sep 13, 2010Estimated
Enrollment
367Actual
Phase
Phase 2
Conditions
Type 2 Diabetes Mellitus
Interventions
INT131 besylate
Pioglitazone HCl
Placebo
Countries
United States
Mexico
Protocol Section
Identification Module
NCT ID
NCT00631007
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INT131-007
Secondary IDs
Not provided
Brief Title
A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator
Official Title
A Randomized, Double-Blind, Placebo-Controlled, 24-Week Study to Evaluate the Efficacy and Safety of INT131 Besylate Compared to Pioglitazone in Subjects With Type 2 Diabetes
Acronym
Not provided
Organization
InteKrin Therapeutics, Inc.INDUSTRY
Status Module
Record Verification Date
Aug 2010
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 2008
Primary Completion Date
Aug 2009Actual
Completion Date
Sep 2009Actual
First Submitted Date
Feb 27, 2008
First Submission Date that Met QC Criteria
Mar 6, 2008
First Posted Date
Mar 7, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 18, 2010
Results First Submitted that Met QC Criteria
Aug 18, 2010
Results First Posted Date
Sep 13, 2010Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 18, 2010
Last Update Posted Date
Sep 13, 2010Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
InteKrin Therapeutics, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a 24 week study comparing the efficacy of four dose levels of INT131 besylate with pioglitazone HCl in patients with type 2 diabetes. Eligible patients will be men and women (of non-childbearing potential or using dual barrier methods of contraception) between 30 and 75 years of age who are minimally responsive to treatment with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy.
INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone HCl.
Drug: INT131 besylate
INT131 besylate 1 mg
Experimental
INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone HCl
Drug: INT131 besylate
INT131 besylate 2 mg
Experimental
INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone HCl
Drug: INT131 besylate
INT131 besylate 3 mg
Experimental
INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone HCl
Drug: INT131 besylate
pioglitazone HCl 45 mg
Active Comparator
pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
Drug: Pioglitazone HCl
placebo
Placebo Comparator
Interventions
Name
Type
Description
Arm Group Labels
Other Names
INT131 besylate
Drug
Once-daily, oral
INT131 besylate 0.5 mg
INT131 besylate 1 mg
INT131 besylate 2 mg
INT131 besylate 3 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward
HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent
Weeks 0-24
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.
The change from baseline reflects the Week 24 FPG minus the Week 0 FPG with last observation carried forward.
Weeks 0-24
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Type 2 diabetes and on either sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 3 months at stable dose
Males and Females (of non-childbearing potential or who are using dual barrier methods of contraception) between 30 and 75 years of age
HbA1c must be ≥7.5% and ≤10% at screening
Fasting Plasma Glucose must be <240 mg/dL at screening
Exclusion Criteria:
History of type 1 diabetes
History of diabetic ketoacidosis
NYHA Class III or IV cardiac status or hospitalization for congestive heart failure within 6 weeks prior to Visit 1
Treatment with any non-peroxisome proliferator-activated receptor (non-PPAR) antidiabetic agent, investigational or approved, other than metformin or permitted sulfonylureas within 3 months prior to screening
Treatment with rosiglitazone, pioglitazone, or any PPAR investigational antidiabetic agent within 6 month prior to screening
Presence of diabetic complications, which in the opinion of the investigator, would complicate the subject's participation in the study (i.e., require initiation of new medication)
DePaoli AM, Higgins LS, Henry RR, Mantzoros C, Dunn FL; INT131-007 Study Group. Can a selective PPARgamma modulator improve glycemic control in patients with type 2 diabetes with fewer side effects compared with pioglitazone? Diabetes Care. 2014 Jul;37(7):1918-23. doi: 10.2337/dc13-2480. Epub 2014 Apr 10.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Patients 30 - 75 years of age with type 2 diabetes mellitus with inadequate glycemic control (HbA1c ≥7.5% and ≤ 10% and a Fasting Plasma Glucose <240 mg/dL) at screening on sulfonylurea monotherapy or sulfonylurea plus metformin were eligible to enter the study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
INT131 Besylate 0.5 mg
INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
FG001
INT131 Besylate 1 mg
INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
placebo administered once-daily, matching placebo to INT131 besylate and matching placebo to pioglitazone HCl
Drug: Placebo
Pioglitazone HCl
Drug
Once-daily, oral
pioglitazone HCl 45 mg
Actos
Placebo
Drug
Once-daily, oral
placebo
Los Angeles
California
90057
United States
VA San Diego Healthcare System
San Diego
California
92161
United States
Apex Research Institute
Santa Ana
California
92705
United States
Internal Medicine of the Rockies
Colorado Springs
Colorado
80910
United States
Creekside Endocrine Associates, PC
Denver
Colorado
80209
United States
Clinical Research Consulting, LLC
Milford
Connecticut
06460
United States
MedStar Research Institute
Washington D.C.
District of Columbia
20003
United States
Clinical Research of South Florida
Coral Gables
Florida
33134
United States
The Center for Diabetes and Endocrine Care
Hollywood
Florida
33021
United States
Baptist Diabetes Associates, PA
Miami
Florida
33156
United States
International Research Associates, LLC
Miami
Florida
33156
United States
Elite Research Institute
Miami
Florida
33169
United States
Suncoast Clinical Research, Inc.
New Port Richey
Florida
34652
United States
Suncoast Clinical Research, Inc.
Palm Harbor
Florida
34652
United States
Meridien Research
Tampa
Florida
33606
United States
Meridien Research
Tampa
Florida
34203
United States
Clinical Research of Central Florida
Winter Haven
Florida
33880
United States
Executive Health and Research Associates, Inc.
Atlanta
Georgia
30342
United States
Endocrine Research Solutions, Inc.
Roswell
Georgia
30076
United States
Cedar-Crosse Research Center
Chicago
Illinois
60607
United States
ICCT Reseach International
Chicago
Illinois
60611
United States
American Health Network
Indianapolis
Indiana
46254
United States
L-Marc Research Center
Louisville
Kentucky
40213
United States
New Orleans Center for Clinical Research
New Orleans
Louisiana
70119
United States
Stephen R. Smith, MD
Baltimore
Maryland
21234
United States
Olive Branch Family Medical Center
Olive Branch
Mississippi
38654
United States
Diabetes and Endocrinology Specialists, Inc.
Chesterfield
Missouri
63017
United States
Saint Luke's Lipid and Diabetes Reseach Center
Kansas City
Missouri
64111
United States
Bozeman Deaconess Internal Medicine Associates
Bozeman
Montana
59715
United States
Comprehensive Clinical Research
Berlin
New Jersey
08009
United States
Kaleida Health Diabetes Center
Buffalo
New York
14209
United States
UNC Diabetes Care Center/Highgate Specialty Center
Durham
North Carolina
27713
United States
Fairbrook Medical Clinic
Hickory
North Carolina
28602
United States
Diabetes & Endrocrinology Consultants
Morehead City
North Carolina
28557
United States
The Lindner Clinical Trial Center
Cincinnati
Ohio
45219
United States
IVA Research
Cincinnati
Ohio
45245
United States
Rapid Medical Research, Inc
Cleveland
Ohio
44122
United States
Opitmed Research, LTD
Columbus
Ohio
43235
United States
ResEvo LLC
Cuyahoga Falls
Ohio
44223
United States
Delaware Smith Clinic
Delaware
Ohio
43015
United States
Prestige Clinical Research
Franklin
Ohio
45005
United States
Wells Institute for Health Awareness
Kettering
Ohio
45429
United States
Frederick C Smith Clinic
Marion
Ohio
43302
United States
Your Diabetes Endocrine Nutrition Group, LLC
Mentor
Ohio
44060
United States
Clinical Research Source, Inc
Perrysburg
Ohio
43551
United States
Tri-State Medical Group, Inc.
Beaver
Pennsylvania
15009
United States
Lycoming Internal Medicine, Inc.
Jersey Shore
Pennsylvania
17740
United States
New England Center for Clinical Research
Cranston
Rhode Island
02920
United States
Hartwell Research Group
Anderson
South Carolina
29621
United States
Medical Research South
Charleston
South Carolina
29407
United States
Palmetto Clinical Trial Services, LLC
Simpsonville
South Carolina
29681
United States
Dallas Diabetes and Endocrine Research Center
Dallas
Texas
75230
United States
Research Institute of Dallas
Dallas
Texas
75231
United States
Baylor University Endocrine Center
Dallas
Texas
75246
United States
Diabetes Center of the Southwest
Midland
Texas
79705
United States
Quality Research, Inc.
San Antonio
Texas
78209
United States
DGD Research
San Antonio
Texas
78229
United States
Salem VA Medical Center R&D Office
Salem
Virginia
24153
United States
Nucleo Medico Vallarta
Guadalajara
Jalisco
Mexico
Comite Mexicano para la Prevencion de la Osteoporosis A.C.
Mexico City
Mexico DF
06100
Mexico
Centro Especializado en Diabetes y Obisidad (EDOPEC)
Mexico City
Mexico DF
11650
Mexico
Instituto Nacional de Nutricion Salvador Zubiran (INNSZ)
Mexico City
Mexico DF
14000
Mexico
Instituto Mexicano de Investigacion Clinica
Mexico City
Mexico DF
Mexico
Unidad Metabolica y Cardiovascular SC
Cuernavaca
Morelos
Mexico
Hospital Santa Engracia
Monterrey
Nuevo León
66220
Mexico
FG002
INT131 Besylate 2 mg
INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
FG003
INT131 Besylate 3 mg
INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
FG004
Pioglitazone HCl 45 mg
pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
FG005
Placebo
placebo administered once-daily
FG00060 subjects
FG00161 subjects
FG00263 subjects
FG00362 subjects
FG00460 subjects
FG00561 subjects
COMPLETED
FG00049 subjects
FG00150 subjects
FG00253 subjects
FG00353 subjects
FG00448 subjects
FG00546 subjects
NOT COMPLETED
FG00011 subjects
FG00111 subjects
FG00210 subjects
FG0039 subjects
FG00412 subjects
FG00515 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG0043 subjects
FG0052 subjects
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0034 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Persistent Hyperglycemia
FG0002 subjects
FG0012 subjects
FG0025 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0004 subjects
FG0015 subjects
FG0022 subjects
FG0032 subjects
FG004
Other
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
INT131 Besylate 0.5 mg
INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
BG001
INT131 Besylate 1 mg
INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
BG002
INT131 Besylate 2 mg
INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
BG003
INT131 Besylate 3 mg
INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
BG004
Pioglitazone HCl 45 mg
pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
BG005
Placebo
placebo administered once-daily
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00060
BG00161
BG00263
BG00361
BG00460
BG00561
BG006366
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00054.9± 8.48
BG00158.0± 9.18
BG00256.1± 7.98
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00024
BG00129
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00029
BG00131
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0006
BG0017
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00051
BG00150
BG002
Hemoglobin A1c
Mean
Standard Deviation
Percent
Title
Denominators
Categories
Title
Measurements
BG0008.3± 0.76
BG0018.3± 0.71
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward
HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent
Randomized subjects who took at least 1 dose of double blind treatment. To be included in analysis of change from baseline to week 24 with last observation carried forward, subjects must have had baseline measurement and at least 1 post baseline measurement.
Posted
Mean
Standard Deviation
Percernt
Weeks 0-24
ID
Title
Description
OG000
INT131 Besylate 0.5 mg
INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
OG001
INT131 Besylate 1 mg
INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
OG002
INT131 Besylate 2 mg
INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
OG003
INT131 Besylate 3 mg
INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
OG004
Pioglitazone HCl 45 mg
pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
OG005
Placebo
placebo administered once-daily
Units
Counts
Participants
OG00060
OG00159
OG00261
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.3± 0.86
OG001-0.6± 0.72
OG002-0.9± 0.97
OG003
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward.
The change from baseline reflects the Week 24 FPG minus the Week 0 FPG with last observation carried forward.
Randomized subjects who took at least 1 dose of double blind treatment. To be included in analysis of change from baseline to week 24 with last observation carried forward, subjects must have had baseline measurement and at least 1 post baseline measurement.
Posted
Mean
Standard Deviation
mg/dL
Weeks 0-24
ID
Title
Description
OG000
INT131 Besylate 0.5 mg
INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
OG001
INT131 Besylate 1 mg
INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
OG002
INT131 Besylate 2 mg
INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
OG003
INT131 Besylate 3 mg
INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
Time Frame
Adverse events were collected from randomization to week 26.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
INT131 Besylate 0.5 mg
INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone.
1
60
15
60
EG001
INT131 Besylate 1 mg
INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone
1
61
37
61
EG002
INT131 Besylate 2 mg
INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone
2
63
37
63
EG003
INT131 Besylate 3 mg
INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone
0
61
35
61
EG004
Pioglitazone HCl 45 mg
pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate
4
60
34
60
EG005
Placebo
placebo administered once-daily
4
61
24
61
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected63 at risk
EG0030 events0 affected61 at risk
EG004
Angina pectoris
Cardiac disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected63 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected63 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected63 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected63 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected63 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected61 at risk
EG0021 events1 affected63 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected63 at risk
EG003
Gastroesophageal reflux disease
Gastrointestinal disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected63 at risk
EG003
Influenza
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected60 at risk
EG0011 events1 affected61 at risk
EG0020 events0 affected63 at risk
EG003
Non-Cardiac chest pain
General disorders
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected63 at risk
EG003
Pharyngeal abscess
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected63 at risk
EG003
Staphylococcal abscess
Infections and infestations
MedDRA (11.0)
Non-systematic Assessment
EG0000 events0 affected60 at risk
EG0010 events0 affected61 at risk
EG0022 events1 affected63 at risk
EG003
Spermatocele
Reproductive system and breast disorders
MedDRA (11.0)
Non-systematic Assessment
EG0001 events1 affected60 at risk
EG0010 events0 affected61 at risk
EG0020 events0 affected63 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0002 affected60 at risk
EG0010 affected61 at risk
EG0024 affected63 at risk
EG0033 affected61 at risk
EG0040 affected60 at risk
EG0052 affected61 at risk
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA (11.0)
Systematic Assessment
EG0004 affected60 at risk
EG0012 affected61 at risk
EG0021 affected63 at risk
EG003
Hypoglycemia
Metabolism and nutrition disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected60 at risk
EG0013 affected61 at risk
EG0027 affected63 at risk
EG003
Influenza
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0002 affected60 at risk
EG0015 affected61 at risk
EG0025 affected63 at risk
EG003
Oedema peripheral
General disorders
MedDRA (11.0)
Systematic Assessment
EG0003 affected60 at risk
EG0018 affected61 at risk
EG0028 affected63 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0001 affected60 at risk
EG0012 affected61 at risk
EG0023 affected63 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (11.0)
Systematic Assessment
EG0002 affected60 at risk
EG0018 affected61 at risk
EG0023 affected63 at risk
EG003
Weight gain
Investigations
MedDRA (11.0)
Systematic Assessment
EG0000 affected60 at risk
EG0012 affected61 at risk
EG0021 affected63 at risk
EG003
diarrhoea
Gastrointestinal disorders
MedDRA (11.0)
Systematic Assessment
EG0001 affected60 at risk
EG0012 affected61 at risk
EG0022 affected63 at risk
EG003
headache
Nervous system disorders
MedDRA (11.0)
Systematic Assessment
EG0000 affected60 at risk
EG0015 affected61 at risk
EG0023 affected63 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Investigator and Institution shall only be permitted to publish or present the results of that portion of the Study conducted at Institution with Sponsor's prior written consent, which consent may be withheld at Sponsor's sole discretion.
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Executive Officer
InteKrin Therapeutics
650-941-5501
Info@intekrin.com
ID
Term
D003924
Diabetes Mellitus, Type 2
D003920
Diabetes Mellitus
D004700
Endocrine System Diseases
D009750
Nutritional and Metabolic Diseases
Ancestor Terms
ID
Term
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000077205
Pioglitazone
Ancestor Terms
ID
Term
D045162
Thiazolidinediones
D013844
Thiazoles
D013457
Sulfur Compounds
D009930
Organic Chemicals
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
5 subjects
FG0053 subjects
0 subjects
FG0052 subjects
2 subjects
FG0055 subjects
1 subjects
FG0053 subjects
1 subjects
FG0050 subjects
54.8
± 9.76
BG00455.8± 10.40
BG00555.3± 10.93
BG00655.8± 9.50
32
BG00325
BG00432
BG00528
BG006170
Male
BG00036
BG00132
BG00231
BG00336
BG00428
BG00533
BG006196
29
BG00332
BG00428
BG00531
BG006180
Not Hispanic or Latino
BG00031
BG00130
BG00234
BG00329
BG00432
BG00530
BG006186
6
BG0035
BG0045
BG0057
BG00636
Asian
BG0000
BG0010
BG0022
BG0031
BG0041
BG0050
BG0064
Native Hawaiian or Other Pacific Islander
BG0001
BG0010
BG0020
BG0030
BG0041
BG0052
BG0064
Black or African American
BG0007
BG0014
BG00210
BG0036
BG0049
BG0056
BG00642
White
BG00046
BG00150
BG00245
BG00349
BG00444
BG00546
BG006280
52
BG00352
BG00451
BG00549
BG006305
Mexico
Title
Measurements
BG0009
BG00111
BG00211
BG0039
BG0049
BG00512
BG00661
8.5
± 0.69
BG0038.3± 0.65
BG0048.2± 0.67
BG0058.4± 0.80
BG0068.3± 0.72
60
OG00458
OG00558
-1.0
± 0.80
OG004-0.9± 0.94
OG005-0.1± 0.87
OG004
Pioglitazone HCl 45 mg
pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate