A Study of ASP1941 in Combination With Insulin in Patients With Type 1 Diabetes Mellitus

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Phase III Study of ASP1941 Double-blind, Parallel-group Study in Combination With Insulin in Patients With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02897219
• Other study ID #: 1941-CL-6002
• Status: Completed
• Phase: Phase 3
• Start date: August 29, 2016
• Est. completion date: March 15, 2018

Study information

• Verified date: March 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to confirm efficacy of ASP1941 based on the changes in HbA1c and to assess its safety in subjects with type 1 diabetes mellitus receiving ASP1941 once daily in combination with insulin for 24 weeks. This study will also assess the safety/efficacy of long-term treatment (52 weeks).

Description:

This study consists of two parts. In Part 1, ASP1941 or placebo will be administered orally in a blind manner. In Part 2, the long-term safety and efficacy of ASP1941 will be evaluated in patients who have participated in the study and completed the Part 1.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: March 15, 2018
• Est. primary completion date: July 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• The subject has been diagnosed with type 1 diabetes mellitus

• The subject has been receiving insulin therapy for the treatment of diabetes mellitus.

• The subject has not switched from an insulin product to another insulin product or switched between continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI).

• The subject has an HbA1c value between 7.5% and 11.0% and the difference of HbA1c value is within ± 2.0%.

• The subject has a fasting blood C-peptide level < 0.6 ng/mL.

• The subject has a body mass index (BMI) between 20.0 kg/m2 and 35.0 kg/m2.

Exclusion Criteria:

• The subject has type 2 diabetes mellitus.

• The subject has participated in a clinical study or post marketing study of another drug or medical equipment within 12 weeks (84 days) before providing written informed consent, or is currently participating in such a study.

• The subject has received treatment with ASP1941 (ipragliflozin) or participated in a clinical study of ASP1941 (excluding subjects who discontinued before the investigational period).

• The subject participated in this study previously.

• The subject has received a hypoglycemic agent other than insulin or an a-glucosidase inhibitor.

• The subject has proliferative retinopathy (except for those who have undergone photocoagulation etc. and whose symptoms are stable).

• The subject has experienced severe hypoglycemia.

• The subject has experienced diabetic ketoacidosis.

• The subject has chronic disease that requires the continuous use of corticosteroids, immunosuppressants, etc.

• The subject has symptomatic urinary tract infection or symptomatic genital infection.

• The subject has a history of recurrent urinary tract infection or recurrent genital infection.

• The subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, or another serious heart disease.

• The subject has a concomitant malignant tumor or a history of malignant tumor

• The subject has a history of an allergy to ASP1941 (ipragliflozin) and/or similar drugs (drugs possessing SGLT2 inhibitory action).

• The subject has psychiatric disorder that is inappropriate for participation in the study.

• The subject has drug addiction or alcohol abuse.

• The subject has severe infection or serious trauma, or is perioperative.

• The subject has a history of medically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant.

• The subject has any symptoms of dysuria, anuria, oliguria, or urinary retention.

• The subject has severe renal impairment or end-stage renal failure requiring dialysis.

• The subject has an Aspartate Aminotransferase and/or Alanine Aminotransferase value that exceeds 2 times, or a total bilirubin value that exceeds 1.5 times the upper limit of the reference range.

• The subject has uncontrolled severe hypertension.

• The subject has serious gastrointestinal disease or a history of operation for serious gastrointestinal disease.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• ipragliflozin
Oral administration once daily
• Placebo
Oral administration once daily

Other:
• Insulin Therapy
Continuous subcutaneous insulin infusion or multiple daily injections as standard of care

Locations

Country	Name	City	State
Japan	Site JP00005	Aichi
Japan	Site JP00028	Aichi
Japan	Site JP00003	Chiba
Japan	Site JP00013	Chiba
Japan	Site JP00035	Chiba
Japan	Site JP00022	Fukuoka
Japan	Site JP00023	Fukuoka
Japan	Site JP00031	Fukuoka
Japan	Site JP00002	Gunma
Japan	Site JP00011	Gunma
Japan	Site JP00006	Hiroshima
Japan	Site JP00033	Hokkaido
Japan	Site JP00034	Hokkaido
Japan	Site JP00021	Hyogo
Japan	Site JP00009	Ibaraki
Japan	Site JP00010	Ibaraki
Japan	Site JP00004	Kanagawa
Japan	Site JP00015	Kanagawa
Japan	Site JP00016	Kanagawa
Japan	Site JP00019	Mie
Japan	Site JP00008	Nagasaki
Japan	Site JP00024	Nagasaki
Japan	Site JP00025	Nagasaki
Japan	Site JP00032	Nagasaki
Japan	Site JP00026	Niigata
Japan	Site JP00020	Osaka
Japan	Site JP00029	Osaka
Japan	Site JP00036	Osaka
Japan	Site JP00012	Saitama
Japan	Site JP00017	Shizuoka
Japan	Site JP00018	Shizuoka
Japan	Site JP00001	Tochigi
Japan	Site JP00030	Tokushima
Japan	Site JP00014	Tokyo
Japan	Site JP00027	Toyama
Japan	Site JP00007	Yamaguchi

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c		Baseline and Week 24 (end of treatment period 1)
Secondary	Change from baseline in HbA1c		Baseline and up to Week 56
Secondary	Change from baseline in Fasting plasma glucose		Baseline and up to Week 56
Secondary	Change from baseline in self-monitored blood glucose level		Baseline and up to Week 56
Secondary	Change from baseline in leptin		Baseline and up to Week 52
Secondary	Change from baseline in glycoalbumin		Baseline and up to Week 52
Secondary	Change from baseline in adiponectin		Baseline and up to Week 52
Secondary	Change from baseline in glucagon		Baseline and up to Week 52
Secondary	Change from baseline in number of units of insulin administered concomitantly	Comprehensively assessed by basal insulin daily dose, bolus insulin daily dose and total insulin daily dose.	Baseline and up to Week 56
Secondary	Change from baseline in body weight		Baseline and up to Week 56
Secondary	Change from baseline in waist circumference		Baseline and up to Week 52
Secondary	Safety assessed by incidence of adverse events		Up to Week 56
Secondary	Safety assessed by sitting blood pressure		Up to Week 56
Secondary	Safety assessed by sitting pulse rate		Up to Week 56
Secondary	Safety assessed by standard 12-lead electrocardiogram		Up to Week 56
Secondary	Safety assessed by laboratory tests: Hematology		Up to Week 56
Secondary	Safety assessed by laboratory tests: Biochemistry		Up to Week 56
Secondary	Safety assessed by laboratory tests: Urinalysis		Up to Week 56

External Links

•   Link to results on the Astellas Clinical Study Results website