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Trial record 50 of 126 for:    diabetes type 1 AND (woman OR women OR female) AND Metabolism

The PK and PD of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM

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ClinicalTrials.gov Identifier: NCT02582840
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This randomized, single-blind, 3 arm, parallel group, placebo controlled PK/PD study will enrol 30 Japanese male and female patients with T1DM and age 18 to 65 years, with inadequate glycemic control on insulin defined as HbA1c ≥ 7.0% and ≤ 10.0% at screening visit. lacebo-controlled design. Patients will be randomized in a 1:1:1 ratio into one of the 3 single-blinded treatment arms; dapagliflozin 5 mg, dapagliflozin 10 mg or placebo. CSII user are excluded.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Dapagliflozin 5mg Drug: Dapagliflozin 10mg Drug: Placebo tablet Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Clinical Pharmacology and Long Term Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With Type 1 Diabetes Who Have Inadequate Glycemic Control
Study Start Date : October 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: dapagliflozin 5mg
dapagliflozin tablet 5mg
Drug: Dapagliflozin 5mg
Dapagliflozin, a blood glucose lowering drug. Oral dose

Experimental: dapagliflozin 10mg
dapagliflozin tablet 10mg
Drug: Dapagliflozin 10mg
Dapagliflozin, a blood glucose lowering drug. Oral dose

Placebo Comparator: Placebo
dapagliflozin tablet 5mg placebo or 10 mg placebo
Drug: Placebo tablet
Placebo tablet. Oral dose




Primary Outcome Measures :
  1. <Part A>PK variables: Cmax for dapagliflozin and dapagliflozin 3-Oglucuronide [ Time Frame: From baseline to 7 days ]
    To evaluate the pharmacokinetics (PK) of 7 days repeated doses of dapagliflozin in Japanese patients with type 1 diabetes mellitus (T1DM) with inadequate glycemic control under standard insulin therapy.

  2. <Part A>PK variables: Tmax for dapagliflozin and dapagliflozin 3-Oglucuronide [ Time Frame: From baseline to 7 days ]
    To evaluate the pharmacokinetics (PK) of 7 days repeated doses of dapagliflozin in Japanese patients with type 1 diabetes mellitus (T1DM) with inadequate glycemic control under standard insulin therapy.

  3. <Part A>PK variables: AUCτ for dapagliflozin and dapagliflozin 3-Oglucuronide [ Time Frame: From baseline to 7 days ]
    To evaluate the pharmacokinetics (PK) of 7 days repeated doses of dapagliflozin in Japanese patients with type 1 diabetes mellitus (T1DM) with inadequate glycemic control under standard insulin therapy.

  4. <Part A>PK variables: Ratio of dapagliflozin 3-O-glucuronide AUCτ to dapagliflozin AUCτ. [ Time Frame: From baseline to 7 days ]
    To evaluate the pharmacokinetics (PK) of 7 days repeated doses of dapagliflozin in Japanese patients with type 1 diabetes mellitus (T1DM) with inadequate glycemic control under standard insulin therapy.

  5. <Part A>PD variables: 24 hour urinary glucose excretion to Day 7. [ Time Frame: From baseline to 7 days ]
    To evaluate the pharmacodynamics (PD) of 7 days repeated doses of dapagliflozin in Japanese patients with type 1 diabetes mellitus (T1DM) with inadequate glycemic control under standard insulin therapy.


Secondary Outcome Measures :
  1. <Part A>Change from baseline in fasting plasma glucose (FPG) on Day7 [ Time Frame: From baseline to 7 days ]
    To evaluate the PD of 7 days repeated doses of dapagliflozin in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.

  2. <Part A>Change from baseline in daily insulin dose on Day7 [ Time Frame: From baseline to 7 days ]
    To evaluate the PD of 7 days repeated doses of dapagliflozin in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.

  3. <Part A>Change from baseline in SBP on Day7 [ Time Frame: From baseline to 7 days ]
    To evaluate the PD of 7 days repeated doses of dapagliflozin in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.

  4. <Part A>Adverse event [ Time Frame: From baseline to 7 days ]
    To assess the safety and tolerability of 7 days repeated doses of dapagliflozin in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.

  5. <Part A>Physical examination [ Time Frame: From baseline to 7 days ]
    To assess the safety and tolerability of 7 days repeated doses of dapagliflozin in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.

  6. <Part A>ECG [ Time Frame: From baseline to 8 days ]
    To assess the safety and tolerability of 7 days repeated doses of dapagliflozin in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.

  7. <Part A>Clinical laboratory measures, urine test. [ Time Frame: From baseline to 7 days ]
    To assess the safety and tolerability of 7 days repeated doses of dapagliflozin in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed Written Informed Consent Subjects or their legally responsible representatives must be willing and able to give signed and dated written informed consent.
  • Target Population Diagnosis of T1DM. In addition, the following criteria also needs to be met; Central laboratory test of C-peptide < 0.7 ng/mL Subject re-enrolment: This study does not permit the re-enrolment of a subject who has discontinued the study as a screen failure
  • Insulin use for at least 12 months prior to the enrolment per subject report or medical records and Method of insulin administration (MDI) must have been unchanged for at least 3 months prior to the enrolment per subject report or medical records. Subjects must be taking a total daily insulin dose of ≥ 0.3 U/kg/day for at least 3 months prior to the enrolment. CSII users are excluded. MDI insulin administration subject must be on ≥ 3x injections per day.
  • Gender and reproductive Status Japanese men and women.
  • HbA1c eligibility criteria include: Screening Visit: Central laboratory HbA1c ≥ 7.0 % and ≤ 10.0 % (One repeat HbA1c test for subjects in screening if their initial test result was an HbA1c ± 0.2% of the cut off values)
  • BMI ≥ 20.0 kg/m², ≤ 35.0 kg/m² at visit 1
  • Ages 18 to 65 years, inclusive - ≥ 18 years old and < 20 years old must have assent forms signed and dated by their parents or guardians

Exclusion Criteria:

  • Target Disease Exceptions History of T2DM In cases where the subject has a history of T2DM and has a documented history of being auto-antibody positive for GAD65, tyrosine phosphatase IA-2/IA-2β, or Zinc Transporter 8 (ZnT8), or fasting c-peptide value below the lower limit of detection performed by local or central laborator, the subject will be eligible for screening
  • Maturity onset diabetes of young (MODY), Pancreatic surgery, chronic pancreatitis, or other pancreatic disorders that could result in decreased β-cell capacity (eg, pancreatogenous diabetes)
  • Any antihyperglycemic agent use, other than thiazolidinediones, or insulin, within 1 month prior to the screening visit. Use of thiazolidinediones within 6 months prior to the screening visit.
  • History of DKA requiring medical intervention (eg, emergency room visit and/or hospitalization) within 1 month prior to the enrolment
  • History of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to the enrolment
  • Malignancy within 5 years of the enrolment (with the exception of treated basal cell or treated squamous cell carcinoma)
  • History of bladder cancer
  • History of radiation therapy to the lower abdomen or pelvis at any time Unstable pre-proliferative and proliferative retinopathy (untreated or under treatment).
  • Physical and Laboratory Test Findings Aspartate aminotransferase (AST) > 3x upper limit of normal (ULN) Alanine aminotransferase (ALT) > 3x ULN Serum total bilirubin (TB) > 2.0 mg/dL (34.2 μmol/L).
  • Estimated GFR (eGFR) by the Japanese Society of Nephrology formula ≤ 60 mL/min/1.73m2. Hemoglobin ≤ 11.0 g/dL (110 g/L) for men; hemoglobin ≤ 10.0 g/dL (100 g/L) for women.
  • Positive for hepatitis B surface antigen or anti-hepatitis C virus antibody
  • Abnormal Free T4

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582840


Locations
Japan
Fukuoka-shi, Japan
Sponsors and Collaborators
AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02582840     History of Changes
Other Study ID Numbers: D1695C00001sub
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016

Keywords provided by AstraZeneca:
Japanese patients with type 1 diabetes with inadequate glycemic control on insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs