Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus - Full Text View

Purpose

The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients either treated with metformin or treatment-naïve.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: JTT-851 Drug: Glimepiride Drug: Placebo for Active Drug: Placebo for comparator	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 Phase 2, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of JTT-851 in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Glimepiride

U.S. FDA Resources

Further study details as provided by Akros Pharma Inc.:

Primary Outcome Measures:

Change in glycosylated hemoglobin (HbA1c) after administration of JTT-851 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To investigate the change in glycosylated hemoglobin (HbA1c) after JTT-851 administration, once daily for 12 weeks

Secondary Outcome Measures:

Safety and tolerability of JTT-851 in patients with type 2 diabetes compared to glimepiride and placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
To evaluate the safety and tolerability of JTT-851 when administered for 12 weeks in patients with type 2 diabetes compared to glimepiride and placebo.
Effect on ancillary efficacy measures [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To investigate the effect of JTT-851 administration on ancillary efficacy measures in patients with type 2 diabetes compared to glimepiride and placebo.
Pharmacokinetics of JTT-851 and its metabolites [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To evaluate the pharmacokinetics of JTT-851 and its metabolites in patients with type 2 diabetes

Other Outcome Measures:

Relationship between dose and response of JTT-851 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To explore the relationship between the JTT-851 dose (exposure) and response

Estimated Enrollment:	300
Study Start Date:	September 2012
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: JTT-851 Dose 1 JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks	Drug: JTT-851 Drug: Placebo for comparator
Experimental: JTT-851 Dose 2 JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks	Drug: JTT-851 Drug: Placebo for comparator
Experimental: JTT-851 Dose 3 JTT-851 Tablets and Placebo comparator capsule, administered once daily for 12 weeks	Drug: JTT-851 Drug: Placebo for comparator
Active Comparator: Glimepiride Dose 1 Active Comparator Capsule and Placebo Tablets, administered once daily for 12 weeks	Drug: Glimepiride Encapsulated Glimepiride tablets Drug: Placebo for Active
Placebo Comparator: Placebo active & Placebo comparator Placebo Tablets for study drug and Placebo Capsule for active comparator, administered once daily for 12 weeks	Drug: Placebo for Active Drug: Placebo for comparator

Detailed Description:

This is a randomized, double-blind, double-dummy, placebo and active-controlled (glimepiride), multi-center, parallel-group study to investigate the effect of JTT-851 on HbA1c and other ancillary efficacy parameters and to assess the safety, tolerability, and pharmacokinetics of JTT-851 in inadequately-controlled treatment-naïve or metformin-treated type 2 diabetic patients.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females with type 2 diabetes, 18-70 years of age at Visit 1
Managing diabetes with diet and exercise only or currently being treated with a stable dose of metformin (at least 1500 mg/day)
Glycosylated hemoglobin at Visit 1 between 7.5% and 10.0%, if on metformin and between 7.5% and 10.9%, if without treatment
Body mass index (BMI) ≥ 23.0 kg/m^2 and ≤ 45.0 kg/m^2 at Visit 1

Exclusion Criteria:

Females who are pregnant or breast-feeding
Known medical history or presence of type 1 diabetes or acute metabolic diabetic complications, unstable or rapidly progressing retinopathy, nephropathy or neuropathy
Acute coronary syndrome or uncontrolled hypertension
Does not meet all diet or previous/concomitant medication restriction criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699737

Show 79 Study Locations

Sponsors and Collaborators

Akros Pharma Inc.

Investigators

Study Chair:

Hisashi Kodama, Ph.D.

Akros Pharma Inc.

More Information

No publications provided

Responsible Party:	Akros Pharma Inc.
ClinicalTrials.gov Identifier:	NCT01699737 History of Changes
Other Study ID Numbers:	AT851-U-12-002
Study First Received:	October 2, 2012
Last Updated:	January 28, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Akros Pharma Inc.:

Diabetes

Additional relevant MeSH terms:

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

Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013