A Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

• Sponsor: Astellas Pharma Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01023945
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Actual Duration (Months): 4.6
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief Summary

The primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety, tolerability and pharmacokinetics are also evaluated.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: ASP1941; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Randomized, Double-blind, Placebo Controlled, Monotherapy Study to Assess the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
• Actual Study Start Date: Nov 7, 2009
• Actual Primary Completion Date: Mar 26, 2010
• Actual Study Completion Date: Mar 26, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP1941 high dose group oral	Drug: ASP1941; oral
Experimental: ASP1941 low dose group oral	Drug: ASP1941; oral
Placebo Comparator: Placebo group oral	Drug: Placebo; oral

Outcome Measures

Primary Outcome Measures

1. Change in plasma glucose levels [On day 14]

Secondary Outcome Measures

1. Urinary glucose excursion [On day 14]

2. Pharmacokinetic parameter of ASP1941 [On day 14]

3. Safety by adverse events, routine safety laboratories and vital signs. [During treatment]

4. Change in serum insulin levels [On day 14]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type 2 diabetic patients for at least 12 weeks

• HbA1c value between 7.0 and 10.0% at screening

• Fasting plasma glucose ≥ 126mg/dL and < 240mg/dL at screening

• Body Mass Index (BMI) 20.0 - 45.0 kg/m2.

Exclusion Criteria:

• Type 1 diabetes mellitus patients

• Serum creatinine > upper limit of normal

• Proteinuria（albumin/creatinine ratio > 300mg/g）

• Dysuria and/or urinary tract infection

• Significant renal, hepatic or cardiovascular diseases

• Severe gastrointestinal diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Kantou		Japan

Sponsors and Collaborators

• Astellas Pharma Inc

Investigators

• Study Chair: Use Central Contact, Astellas Pharma Inc

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Link to results on Astellas Clinical Study Results website

Publications

None provided.

• Responsible Party: Astellas Pharma Inc
• ClinicalTrials.gov Identifier: NCT01023945
• Other Study ID Numbers: 1941-CL-0070
• First Posted: Dec 2, 2009
• Last Update Posted: Aug 9, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Astellas Pharma Inc: ASP1941; Diabetes mellitus; Blood glucose
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Ipragliflozin

Study Results

No Results Posted as of Aug 9, 2018