A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator - Full Text View

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: INT131 besylate Drug: Pioglitazone HCl Drug: Placebo	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Endocrine Diseases Metabolic Disorders

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Further study details as provided by InteKrin Therapeutics, Inc.:

Primary Outcome Measures:

Change From Baseline in Hemoglobin A1c (HBA1c) at Week 24 With Last Observation Carried Forward [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
HbA1c is measured as percent. Thus this change from baseline reflects the week 24 HbA1c percent minus the Week 0 HbA1c percent

Secondary Outcome Measures:

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 With Last Observation Carried Forward. [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
The change from baseline reflects the Week 24 FPG minus the Week 0 FPG with last observation carried forward.

Enrollment:	367
Study Start Date:	February 2008
Study Completion Date:	September 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: INT131 besylate 0.5 mg INT131 besylate 0.5 mg once-daily administration and matching placebo to pioglitazone HCl.	Drug: INT131 besylate Once-daily, oral
Experimental: INT131 besylate 1 mg INT131 besylate 1 mg once-daily administration and matching placebo to pioglitazone HCl	Drug: INT131 besylate Once-daily, oral
Experimental: INT131 besylate 2 mg INT131 besylate 2 mg administered once-daily and matching placebo to pioglitazone HCl	Drug: INT131 besylate Once-daily, oral
Experimental: INT131 besylate 3 mg INT131 besylate 3 mg administered once-daily and matching placebo to pioglitazone HCl	Drug: INT131 besylate Once-daily, oral
Active Comparator: pioglitazone HCl 45 mg pioglitazone HCl 45 mg administered once-daily and matching placebo to INT131 besylate	Drug: Pioglitazone HCl Once-daily, oral Other Name: Actos
Placebo Comparator: placebo placebo administered once-daily, matching placebo to INT131 besylate and matching placebo to pioglitazone HCl	Drug: Placebo Once-daily, oral

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Body mass index >45 kg/m2
Fasting triglycerides >500 mg/dL
Uncontrolled hypertension (sitting systolic blood pressure >160 mmHg and/or sitting diastolic blood pressure >100 mmHg
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631007

Show 66 Study Locations

Sponsors and Collaborators

InteKrin Therapeutics, Inc.

Investigators

Study Director:

David Orloff, MD

Medpace, Inc.

More Information

No publications provided

Responsible Party:	Chief Executive Officer, InteKrin Therapeutics Inc.
ClinicalTrials.gov Identifier:	NCT00631007 History of Changes
Other Study ID Numbers:	INT131-007
Study First Received:	February 27, 2008
Results First Received:	August 18, 2010
Last Updated:	August 18, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by InteKrin Therapeutics, Inc.:

Type 2 diabetes
diabetes
diabetes mellitus
diabetes mellitus, type 2
non-TZD
thiazolidinedione
selective peroxisome proliferator-activated receptor gamma modulator
SPPARM
peroxisome proliferator-activated receptor gamma

PPAR gamma
insulin sensitizer
glucose control
endocrinopathy
hypoglycemic agent
sulfonylurea
metformin
pioglitazone
nutritional and metabolic diseases

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013