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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699737
• Other study ID #: AT851-U-12-002
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2012
• Last updated: July 25, 2013
• Start date: September 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Akros Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• JTT-851

• Glimepiride
Encapsulated Glimepiride tablets
• Placebo for Active

• Placebo for comparator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akros Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship between dose and response of JTT-851	To explore the relationship between the JTT-851 dose (exposure) and response	12 weeks	No
Primary	Change in glycosylated hemoglobin (HbA1c) after administration of JTT-851	To investigate the change in glycosylated hemoglobin (HbA1c) after JTT-851 administration, once daily for 12 weeks	12 weeks	No
Secondary	Safety and tolerability of JTT-851 in patients with type 2 diabetes compared to glimepiride and placebo	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.	12 weeks	Yes
Secondary	Effect on ancillary efficacy measures	To investigate the effect of JTT-851 administration on ancillary efficacy measures in patients with type 2 diabetes compared to glimepiride and placebo.	12 weeks	No
Secondary	Pharmacokinetics of JTT-851 and its metabolites	To evaluate the pharmacokinetics of JTT-851 and its metabolites in patients with type 2 diabetes	12 weeks	No