A study to evaluate the effect of ASP 1941 in adult patients with type 2 diabetes mellitus

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2010/091/000343
• Date of registration: 18-06-2010
• Prospective Registration: Yes
• Primary sponsor: Astellas Pharma Inc
• Public title: A study to evaluate the effect of ASP 1941 in adult patients with type 2 diabetes mellitus
• Scientific title: A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP 1941 in Subjects with Type 2 Diabetes Mellitus.
• Date of first enrolment: 11-08-2010
• Target sample size: 378
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=1545
• Study type: Interventional
• Study design: Other; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 2

Countries of recruitment

Georgia, India, Mexico, Other, Philippines, United States of America

Contacts

• Name: Sheetal Suresh

• Name: Sheetal Suresh

Key inclusion & exclusion criteria

Inclusion criteria: - Subject has been diagnosed with type 2 diabetes

- Subject has a HbA1c value between 6.8 and 9.5%

- Subject has never, is not currently taking anti-diabetic medication OR is receiving a single anti-diabetic agent or low-doses two anti-diabetic medications and is willing to discontinue them during the study

- Subject is on a stable diet and exercise program

- Female subject is not pregnant and agrees to use an acceptable form of contraception throughout the duration of the study
Exclusion criteria: - Subject has type 1 diabetes mellitus
- Subject is using insulin therapy
- Subject has a serum creatinine higher than upper limit of normal
- Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal
- Subject has persistent, uncontrolled severe hypertension as indicated by a systolic blood pressure > 180 mmHg or a diastolic blood pressure of >110 mmHg
- Subject has had significant cardiovascular disease such as myocardial infarction or a vascular intervention (e.g., angioplasty or stent) in the last 3 months
- Subject is known to have hepatitis or be a carrier of hepatitis B surface antigen, hepatitis C virus antibody or is known positive for H1V1 and/or HIV2
- Subject has a history of lactic acidosis
- Subject has a history of drug and alcohol abuse/dependency within last lst 12 months
- Subject has had a malignancy in the last 5 years, except for successfully treated basal or squamous cell carcinoma of the skin or of the cervix
- Subject has a symptomatic urinary tract infection or genital infection
- Female subject is lactating
- Subject has an unstable medicalor psychiatric illness

Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: ASP 1941: Drug(including placebo), Oral tablet (Lowest dose, low dose, high dose, highest dose)
Control Intervention1: Metformin: Active Comparator, Oral tablet

Primary Outcome(s)

Mean change from baseline in Hemoglobin A1c(HbA1c)Timepoint: 12 weeks

Secondary Outcome(s)

1) Mean change from baseline in fasting plasma glucose (FPG)Timepoint: 12 weeks

2) Proportion of subjects achieving target goal of HbA1c less than 7.0%Timepoint: 12 weeks

Secondary ID(s)

NCT01071850

1941-CL-0004

Source(s) of Monetary Support

Astellas Pharma Inc.

Ethics review

Status: Approved
Approval date:
Contact:

Bharti Research Inst of Diabetes & Endocrinology, Institutional Ethics Committee

Status: Approved
Approval date:
Contact:

DIACON Hospital, Ethics Committee

Status: Approved
Approval date:
Contact:

Ethics Committee, Diabetes Thyroid Hormone Research Inst Pvt Ltd

Status: Approved
Approval date:
Contact:

Institutional Ethics Committee of Hormone Care and Research Center